U-2 tech transfer tech transfer tech transfer.pptx

tech transfer tech transfer tech transfer tech transfer tech transfer tech transfer

1. TECHNOLOGY TRANSFER

2. Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”. It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible and authorized party. INTRODUCTION

3. Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies. INTRODUCTION

4. Systematic Process : Technology transfer requires a documented and planned approach. Expert Personnel : It must be carried out by trained and knowledgeable individuals. Quality System: The entire process must operate within a quality system. Comprehensive Documentation: Extensive documentation of data is essential, covering all aspects from development to production and quality control. Key Players: The process involves a sending unit (SU), a receiving unit, and a unit responsible for managing the process, which could be a separate entity. INTRODUCTION

5. Technology transfer can be considered successful if there is documented evidence that the RU can routinely reproduce the transferred product, process or method against a predefined set of specifications as agreed with the SU. In the event that the RU identifies particular problems with the process during the transfer, the RU should communicate them back to the SU to ensure continuing knowledge management. INTRODUCTION

6. Technology transfer projects, particularly those between different companies, have legal and economic implications. If such issues, which may include intellectual property rights, royalties, pricing, conflict of interest and confidentiality, are expected to impact on open communication of technical matters in any way, they should be addressed before and during planning and execution of the transfer. INTRODUCTION

7. This document gives guidance in principle and provides general recommendations on the activities necessary to conduct a successful intra or intersite transfer of technology as described in the Introduction to these guidelines. The intention is to address the basic considerations needed for a successful transfer in order to satisfy the regulatory authority defined for the transfer process. SCOPE

8. The guidelines will be applied to manufacturing active pharmaceutical ingredients (APIs), manufacturing and packaging of bulk materials, manufacturing and packaging of finished pharmaceutical products (FPPs) and/or performing analytical testing. The recommendations provided in these guidelines apply to all dosage forms but need to be adjusted on a case-by-case basis SCOPE

9. ACCEPTANCE CRITERIA Measurable terms under which a test result will be considered acceptable. Active Pharmaceutical Ingredient (API) Substance having direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. GLOSSARY

10. BRACKETING An experimental design to test only the extremes of, for example, dosage strength. The design assumes that the extremes will be representative of all the samples between the extremes. GLOSSARY change control (C/C) A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.

11. commissioning The setting up, adjustment and testing of equipment or a system to ensure that it meets all the requirements, as specified in the user requirement specification, and capacities as specified by the designer or developer GLOSSARY control strategy A planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related tomaterials and components related to drug substances and drug product materials

12. corrective action (C/A) Any action to be taken when the results of monitoring at a critical control point indicate a loss of control. critical Having the potential to impact on product quality or performance in a significant way . critical control point (CCP) A step at which control can be applied and is essential to prevent or eliminate a pharmaceutical quality hazard or to reduce it to an acceptable level. GLOSSARY

13. gap analysis Identification of critical elements of a process which are available at the SU but are missing from the RU. good manufacturing practices (GMP) That part of quality assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization GLOSSARY

14. The RU should be able to accommodate the intended production capacity. If possible, it should be established at the outset whether the intention is to perform single-batch manufacture, continuous production or campaigns. Consideration should be given to the level and depth of detail to be transferred to support production and any further process development and optimization at the RU as intended under the transfer project plan. Production: transfer (processing, packaging and cleaning)

15. The specifications and relevant functional characteristics of the starting materials (APIs and excipients) to be used at the RU should be consistent with materials used at the SU. Any properties which are likely to influence the process or product should be identified and characterized Production: transfer (processing, packaging and cleaning)

16. The SU should provide the RU with the open (applicant’s) part of the API master file (APIMF or drug master file (DMF) or active substance master file (ASMF)), or equivalent information and any relevant additional information on the API of importance for the manufacture of the pharmaceutical product. FOR EXAMPLE,: Manufacturer and associated supply chain; Step of the API to be transferred; Flow chart of synthesis pathway, outlining the process, including entry points for raw materials, critical steps, process controls and intermediates; where relevant, definitive physical form of the API (including photomicrographs and other relevant data) and any polymorphic and solvate forms; Solubility profile; Active pharmaceutical ingredients (API

17. if relevant, pH in solution; partition coefficient, including the method of determination; intrinsic dissolution rate, including the method of determination; particle size and distribution, including the method of determination; bulk physical properties, including data on bulk and tap density, surface area and porosity as appropriate; water content and determination of hygroscopicity, including water activity data and special handling requirements; Active pharmaceutical ingredients (API

18. microbiological considerations (including sterility, bacterial endotoxins and bioburden levels where the API supports microbiological growth) in accordance with national, regional or international pharmacopoeial requirements; specifications and justification for release and end-of-life limits; summary of stability studies conducted in conformity with current guidelines, including conclusions and recommendations on retest date; Active pharmaceutical ingredients (API

19. List of potential and observed synthetic impurities, with data to support proposed specifications and typically observed levels; • information on degradants, with a list of potential and observed degradation products and data to support proposed specifications and typically observed levels; potency factor, indicating observed purity and justification for any Active pharmaceutical ingredients (API

20. recommended adjustment to the input quantity of API for product manufacturing, providing example calculations; and special considerations with implications for storage and or handling, including but not limited to safety and environmental factors (e.g. as specified in material safety data sheets) and sensitivity to heat, light or moisture. Active pharmaceutical ingredients (API

21. Organization and management

22. TRANSFER PROTOCOL HAS… objective; scope; key personnel and their responsibilities; a parallel comparison of materials, methods and equipment; the transfer stages with documented evidence that each critical stage has been satisfactorily accomplished before the next commences; identification of critical control points; experimental design and acceptance criteria for analytical methods; information on trial production batches, qualification batches and process validation; change control for any process deviations encountered; assessment of end-product; arrangements for keeping retention samples of active ingredients, intermediates and finished products, and information on reference substances where applicable; and conclusion, including signed-off approval by project manager.

23. Project team Any transfer project will be managed by a team comprising members with clearly defined key responsibilities. The team should be drawn from members of relevant disciplines from both the SU and RU sites. The team members should have the necessary qualifications and experience to manage their particular aspect of the transfer.

24. Production: transfer (processing, packaging and cleaning) The RU should be able to accommodate the intended production capacity. If possible, it should be established at the outset whether the intention is to perform single-batch manufacture, continuous production or campaigns. Consideration should be given to the level and depth of detail to be transferred to support production and any further process development and optimization at the RU as intended under the transfer project plan. 5.3 Consideration should be given to the technical expertise, site technology and site capabilities for the RU. It should be identified upfront by the SU of any process robustness issues so that plans may be put in place at the RU. 5.4 The SU and the RU should jointly develop a protocol for the transfer of relevant information related to the process under consideration from the SU to the RU, as well as the development of a comparable process at the RU.

25. Information on process and finished pharmaceutical products information Product Characterization : Qualitative & Quantitative CompositionThis section will detail the active ingredients, excipients, and any other components. It'll specify the exact quantity of each ingredient, ensuring the formula is clearly defined Physical Description This slide will describe the product's physical attributes, such as its appearance, color, form (e.g., tablet, powder, liquid), and any other distinguishing physical characteristics. Method of Manufacture This outlines the step-by-step process of how the product is made, from raw materials to the final product. It includes all stages, like mixing, granulation, filling, or sterilization.

26. Information on process and finished pharmaceutical products information Qualitative and Quantitative Composition : This point details the ingredients. The qualitative aspect lists all the components present, while the quantitative aspect specifies the exact amount or concentration of each ingredient. Physical Description : This is a visual and sensory description of the finished product. It includes details like its appearance (color, clarity), form (solid, liquid, powder), odor, and texture. Method of Manufacture : This describes the step-by-step process used to create the product. It outlines the sequence of operations, from raw material procurement to the final finished good.

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28. Information on process and finished pharmaceutical products information In-Process Controls : These are the checks and tests performed during the manufacturing process to ensure the product is being made correctly. This point covers the specific parameters monitored at various stages to maintain quality and consistency.

29. Information on process and finished pharmaceutical products information 1. Granulation In-process controls for granulation focus on the uniformity and physical properties of the granules before they are compressed into tablets. Key parameters checked include: Moisture Content : Ensures the granules are neither too wet (which can cause sticking) nor too dry (which can cause crumbling). This is often measured using a moisture analyzer. Particle Size Distribution : Guarantees the granules have a consistent size range for proper flow and content uniformity. This is checked using sieves. Bulk and Tapped Density : Measures how well the granules will flow and compress.

30. In-Process Controls Coating For tablets that are coated (e.g., for taste masking, ease of swallowing, or controlled release), in-process controls are crucial for a successful final product. Weight Gain : The tablets are weighed before and after coating to ensure the correct amount of coating material has been applied.

31. In-Process Controls Appearance : Visual inspection is performed to check for any defects like chipping, cracking, or color variation. Uniformity : Ensures the coating is evenly distributed across all tablets.

32. In-Process Controls Filling In-process controls for liquid or powder filling processes focus on accuracy and sterility. This is particularly important for injectable products. Fill Volume/Weight : The volume of liquid or weight of powder in each vial, ampoule, or bottle is checked to ensure it meets the labeled amount. Leak Testing : Vials and containers are tested to ensure a proper seal, preventing contamination or product loss. Sterility and Particulate Matter : In sterile environments, samples are taken to check for microbial contamination and foreign particles.

33. FILL VOLUME

34. In-Process Controls Packaging The final stage of in-process controls ensures the product is correctly labeled and packaged for distribution. Label Integrity : Checks are performed to ensure the correct label is affixed and that it is legible, with accurate batch numbers, expiration dates, and bar codes. Blister Pack Integrity : For blister-packed products, checks are done to ensure each cavity contains a tablet and that the seal is secure, preventing moisture ingress. Count and Assembly : Verifies that the correct number of products are placed in each carton and that the package insert is included.

35. Information on process and finished pharmaceutical products information Control Method and Specifications : This refers to the final quality control tests performed on the finished product. The control methods are the specific analytical procedures used, and the specifications are the acceptance criteria or limits that the product must meet.

36. Information on process and finished pharmaceutical products information Uniformity of Dosage Units Content Uniformity : This method involves individually testing a number of units to verify that the API content of each unit falls within a tight specification. Weight Variation : For products with a high percentage of active ingredient, a simpler method of weighing individual units can be used, as the weight directly correlates with the amount of API.

37. Info on process and finished pharma products information Dissolution testing measures how quickly and completely the active ingredient dissolves from a solid dosage form (like a tablet or capsule) in a specific liquid medium. This is a critical quality attribute because for a drug to be absorbed into the bloodstream and be effective, it must first dissolve. The control method uses specialized apparatuses with specific media and stirring speeds. The specification is a percentage of drug released over a certain time (e.g., "not less than 80% dissolved in 30 minutes"). Disintegration testing is a related test that measures the time it takes for a tablet to break apart, but it does not measure drug release.

38. Info on process and finished pharma products information PURITY AND IMPURITIES These tests ensure the finished product is free from harmful chemical contaminants. Purity testing verifies the absence of related substances, degradation products, or residual solvents that may have formed during the manufacturing process. The control method often uses a highly sensitive chromatographic technique to separate and identify these impurities.

39. Info on process and finished pharma products information PURITY AND IMPURITIES The specifications are strict limits for each impurity, often expressed as a percentage of the total drug substance. These limits are set to ensure the product remains safe throughout its shelf life.

40. Info on process and finished pharma products information Microbiological and Particulate Testing Sterility Testing : For injectable products, ophthalmic solutions, and other sterile preparations, this test is performed to confirm the complete absence of viable microorganisms. The control method involves inoculating culture media with the product and incubating it for a set time, with the specification being "no growth.“

41. Info on process and finished pharma products information Microbiological and Particulate Testing Bacterial Endotoxins Test (BET): This test detects and quantifies pyrogens (fever-inducing substances) from Gram-negative bacteria. It is a critical safety measure for any product administered directly into the bloodstream. Particulate Matter : For parenteral products, this test ensures the product is free of visible and sub-visible particles that could cause vascular blockage.

42. Info on process and finished pharma products information Microbiological and Particulate Testing The control method uses a light obscuration or microscopic method, with specifications setting limits on the number and size of particles allowed per container.

43. Information on process and finished pharmaceutical products information Packaging Components : This point identifies and describes all the materials used to package the product. It includes primary packaging (e.g., bottle, blister pack) that is in direct contact with the product, as well as secondary and tertiary packaging.

44. Information on process and finished pharmaceutical products information Packaging Configurations : This outlines the various sizes and arrangements in which the product is sold. It specifies the number of units per box, the volume per container, and any other unique packaging setups. Safety and Handling Considerations : This point covers all necessary information for the safe use, storage, and handling of the product. It includes details about potential hazards, required personal protective equipment (PPE), and proper disposal instructions.

45. SU should provide any information on the history of process information on clinical development, e.g. information on the rationale for the synthesis, route and form selection, technology selection, equipment, clinical tests, and product composition; • information on scale-up activities: process optimization, statistical optimization of critical process parameters, critical quality attributes,

46. Information on process and finished pharmaceutical products information Information on clinical development, e.g. information on the rationale forthe synthesis, route and form selection, technology selection, equipment, clinical tests, and product composition; Information on scale-up activities: process optimization, statistical optimization of critical process parameters, critical quality attributes, pilot report and or information on pilot-scale development activities indicating the number and disposition of batches manufactured;

47. Information on process and finished pharmaceutical products information information or report on full-scale development activities, indicating the number and disposition of batches manufactured, and deviation and change control (sometimes referred to as change management) reports which led to the current manufacturing process;

48. Information on process and finished pharmaceutical products information the change history and reasons, e.g. a change control log, indicating any changes to the process or primary packaging or analytical methods as apart of process optimization or improvement; information on investigations of problems and the outcomes of theinvestigations

49. SU SHOULD SEND THE FOLLOWING TO RU a detailed description of facility requirements and equipment;• information on starting materials, applicable MSDS and storage requirements for raw materials and finished products; description of manufacturing steps (narrative and process maps or flow charts, and or master batch records), including qualification of inprocessing hold times and conditions, order and method of raw material addition and bulk transfers between processing steps; description of analytical methods;

50. SU SHOULD SEND THE FOLLOWING TO RU Identification and justification of control strategy (e.g. identification of critical performance aspects for specific dosage forms, identification of process control points, product quality attributes and qualification of critical processing parameter ranges, statistical process control (SPC) charts); Design space, in cases where this has been defined; validation information, e.g. validation plans and reports; annual product quality reviews;

51. TASKS OF RU comparison and assessment of suitability and qualification of facility andequipment ; description of manufacturing process and flow of personnel and ofmaterials at the RU (narrative and or process maps or flow charts); determination of critical steps in manufacture, including hold times, endpoints, sampling points and sampling techniques (13)

52. TASKS OF RU writing and approval of SOPs for all production operations (e.g. dispensing,granulation or blending or solution preparation, tablet compression, tabletcoating , encapsulation, liquid filling, primary and secondary packagingand in-process quality control), packaging, cleaning, testing and storage;

53. TASKS OF RU evaluation of stability information, with generation of site-specific stability data if required (14); compliance with regulatory requirements for any changes made, e.g. in terms of batch size

54. Packaging The transfer of packaging operations should follow the sameprocedural patterns as those of the production transfer. Information on packaging to be transferred from the SU to the Ru includes specifications for a suitable container or closure system, Any relevant additional information on design, packing, processing or labelling requirements and tamper-evident and anti-counterfeiting measures needed for qualification of packaging components at the RU. For QC testing of packaging components, specifi cations should beprovided for drawings, artwork and material (for example, glass, card orfibre board).

55. Cleaning During the manufacturing process, pharmaceutical products and APIs can be contaminated by other pharmaceutical products or APIs if the plant is processing different products. To minimize the risk of contamination and cross-contamination, operator exposure and environmental effects, adequate cleaning procedures are essential.

56. Cleaning Cleaning procedures and their validation are site-specific. In order for the RU to define its cleaning strategy the SU should provide information on cleaning at the SU to minimize cross-contamination due to residues from previous manufacturing steps, operator exposure and environmental impact, including:— information on solubility of active ingredients, excipients and vehicles;— minimum therapeutic doses of active ingredients;— therapeutic category and toxicological assessment; and— existing cleaning procedures.

57. Cleaning Before the transfer, the SU should provide information on limits for product residues, and the rationale for limit selection. Based on the information provided by the SU, cleaning procedures should be designed at the RU, taking into account relevant characteristics of the starting materials (e.g. potency, toxicity, solubility, corrosiveness and temperature sensitivity), manufacturing equipment design and configuration, cleaning agent and products residue.

58. Quality control: analytical method transfer Transfer of analytical methods should accommodate all the analytical testing required to demonstrate compliance of the product to be transferred with the registered specification Analytical methods used to test pharmaceutical products, starting materials, packaging components and cleaning (residue) samples, if applicable, should be implemented at the testing laboratory before testing of samples for process validation studies is performed by the RU. Process validation samples may be tested at the RU, the SU or a third laboratory.

59. SU’s responsibilities for the transfer of analytical methods Provide method-specific training for analysts and other quality controlstaff , if required; Assist in analysis of QC testing results; Define all methods to be transferred for testing a given product, startingmaterial or cleaning sample; Define experimental design, sampling methods and acceptance criteria; Provide any validation reports for methods under transfer and demonstratetheir robustness;• provide details of the equipment used, as necessary (part of validationreport , if available) and any standard reference samples; Provide approved procedures used in testing; and Review and approve transfer reports.

60. RU’s responsibilities for the transfer of analytical methods review analytical methods provided by the SU, and formally agree onacceptance criteria before execution of the transfer protocol ensure that the necessary equipment for QC is available and qualified at the RU site. The equipment used by the RU during the analytical transfers should meet appropriate specifications to ensure the requirements of the method or specification are met; Ensure that adequately trained and experienced personnel are in place for analytical testing; Provide a documentation system capable of recording receipt and testing of samples to the required specification using approved test methods, and of reporting, recording and collating data and designation of status(approved, rejected, quarantine);

61. Possible experimental designs and acceptance criteria for analytical testing

62. Possible experimental designs and acceptance criteria for analytical testing

63. Premises The SU should provide information on relevant health, safety andenvironmental issues, including: Inherent risks of the manufacturing processes ( e.G. Reactive chemicalhazards , exposure limits, fire and explosion risks); Health and safety requirements to minimize operator exposure ( e.G.Atmospheric containment of pharmaceutical dust); Emergency planning considerations ( e.G. In case of gas or dust release,spillage , fire and firewater run-off); Identification of waste streams and provisions for re-use, recycling and/or disposal.

64. Premises The SU should provide a list of equipment, makes and models involved in the manufacture, filling, packing and or control of the product, process or method to be transferred, together with existing qualification and validation documentation. Relevant documentation may include:— drawings;— manuals;— maintenance logs;— calibration logs; and— procedures (e.g. regarding equipment set-up, operation, cleaning, maintenance, calibration and storage).

65. Premises The RU should review the information provided by the SU togetherwith its own inventory list including the qualification status (IQ, OQ, PQ)of all equipment and systems, and perform a side-by-side comparison of equipment at the two sites in terms of their functionality, makes, models and qualification status.

66. Documentation

67. Qualification and validation The extent of qualification and or validation to be performed should be determined on the basis of risk management principles. Qualification and validation should be documented

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69. Global Regulatory Gatekeepers Three major international bodies set the standards for technology transfer, ensuring safety and quality across borders. Their focuses, while overlapping, have distinct areas of emphasis. FDA, EMA, and WHO. FDA emphasizes strict adherence to cGMP and validation, EMA champions a comprehensive, risk-based approach within a quality system, WHO provides a foundational, globally-applicable framework.

70. AGENCIES IN TECH-TRANSFER Three major international bodies set the standards for technology transfer, ensuring safety and quality across borders. Their focuses, while overlapping, have distinct areas of emphasis. This chart illustrates the primary focus areas of the FDA, EMA, and WHO. The FDA emphasizes strict adherence to cGMP and validation, the EMA champions a comprehensive, risk-based approach within a quality system, and the WHO provides a foundational, globally-applicable framework.

71. Phase 1: Initiation Define the project's scope, objectives, and key stakeholders. A dedicated project team is formed and a high-level plan is created. Phase 2: Planning Conduct a detailed gap analysis between the sending and receiving sites. A comprehensive quality risk assessment is performed to identify and mitigate potential issues. Phase 3: Execution The core of the project: transferring documentation, processes (manufacturing, cleaning), and analytical methods. Training and validation batches are key activities. Phase 4: Close-Out Finalize the summary report, document lessons learned, and formally conclude the project. The receiving unit takes full ownership of the process.

72. The Pillars of Quality: ICH Guidelines Q8 Pharmaceutical Development Focuses on building quality into the product from the very beginning using Quality by Design (QbD) principles. Q9 Quality Risk Management Provides a systematic process for assessing, controlling, and reviewing risks to product quality throughout the lifecycle. Q10 Pharmaceutical Quality System Describes a comprehensive model for a quality system that covers the entire product lifecycle, including tech transfer.

73. Biotech Consortium India Limited (BCIL) A key intermediary focused on the biotech sector. BCIL acts as a facilitator for: ✔Licensing & IP Management ✔Technical & Financial Consulting ✔Project Management Support

74. BCIL 1. Public Sector Enterprise Organizational Structure : BCIL is a not-for-profit company incorporated under the Companies Act of 1956, emphasizing its mission over profit generation. Funding and Capital : Its primary financial sources are government funding and investments from Indian financial institutions. Operational Alignment : As a public sector enterprise, BCIL's operations are aligned with India's national goals and policies for scientific development and public welfare in the biotechnology sector.

75. 2. Government Affiliation BCIL works directly under the supervision of the Department of Biotechnology (DBT) . This ensures that its strategies and projects are in harmony with India's broader biotech policy landscape. This strong government tie provides BCIL with the authority and resources to manage and implement various flagship programs initiated by the DBT, such as the Biotechnology Industry Partnership Programme . The affiliation also lends credibility and trust, which is crucial when brokering deals between public research institutions and private companies.

76. 3. Core Mission BCIL's primary goal is the commercialization of indigenous biotechnology research. It aims to transform lab-scale innovations into market-ready products and processes. It focuses on making scientific research from universities and national labs accessible to the industry , ensuring that public investment in R&D translates into tangible economic and societal benefits. The consortium plays a vital role in building a robust biotech ecosystem in India, which includes supporting startups, facilitating collaborations, and promoting innovation.

77. 4. Facilitator and Intermediary Acting as a nodal agency , BCIL serves as a single point of contact for companies looking to acquire new technologies and for institutions wanting to commercialize their research. It organizes workshops, conferences, and networking events to bring together scientists, entrepreneurs, and investors to foster new business opportunities. The consortium’s expertise helps streamline complex transactions, from initial due diligence to final contract negotiations, making the technology transfer process more efficient.

78. 5. Bridging the Gap BCIL specializes in overcoming the "valley of death" in biotech, which is the difficult transition of a technology from the research phase to a commercially viable product . It provides crucial support for technology validation and scale-up , helping to refine processes to be suitable for industrial-scale manufacturing. By acting as a liaison, it helps resolve common issues like a lack of trust or misalignment of expectations between academic researchers and industrial partners.

79. 6. Licensing Support BCIL assists in the entire licensing lifecycle , including finding potential licensees for technologies developed at public research institutions. It helps in the negotiation of fair and reasonable terms for licensing agreements , ensuring that the intellectual property rights of the technology developers are protected while the licensees receive a commercially viable deal. The consortium manages the administrative and legal aspects of licensing, making it a hassle-free process for both parties.

80. 7. Intellectual Property Management BCIL provides comprehensive services in Intellectual Property (IP) management, including conducting novelty searches, patent landscape analyses, and freedom-to-operate studies. It offers expert advice on filing, prosecuting, and maintaining patents, trademarks, and other IP assets both in India and abroad. The consortium also conducts IP awareness and capacity-building programs for scientists and researchers to help them understand the importance of IP protection.

81. 8. Technical Guidance BCIL's team of experts provides hands-on technical support to companies, offering advice on process optimization, quality control, and troubleshooting during technology implementation. This guidance is essential for ensuring that the transferred technology is successfully integrated into the company’s existing manufacturing processes. It also helps clients in preparing regulatory dossiers and meeting biosafety guidelines , which are critical for the commercialization of biotech products. 9. Project Management Support The consortium provides a structured approach to managing technology transfer projects from start to finish. This includes defining project milestones, allocating resources, and tracking progress to ensure projects are completed on time and within budget. Effective project management by BCIL minimizes risks associated with tech transfer and maximizes the chances of a successful outcome for all stakeholders.

82. 10. Client Focus BCIL's services are tailored to a diverse clientele, ranging from academic institutions and government organizations to first-generation entrepreneurs and large corporations. It provides specialized support to biotech startups that may lack the resources or expertise to navigate the complex landscape of technology commercialization and IP. The consortium works closely with its clients to understand their specific needs and offers customized solutions, positioning itself as a strategic partner in their growth journey.

83. National Research Development Corporation (NRDC) Promotes the commercialization of indigenous technologies from public R&D labs. NRDC's role is vital for: • ✔Patenting & Licensing of Innovations • ✔Transferring Lab-Scale Inventions • ✔Fostering Academia-Industry Links

84. Asian and Pacific Centre for Transfer of Technology (APCTT) Role Promotes Innovation and Technology Transfer: APCTT acts as a facilitator for the transfer and commercialization of new and emerging technologies, including those in the pharmaceutical sector. Strengthens National Capacity: It assists member countries in developing their abilities to manage national innovation systems and improve the terms of technology transfer. Fosters Regional Cooperation: The center promotes networks and partnerships among governments, R&D institutions, and private companies to facilitate the transfer of environmentally sound technologies and other innovations across the Asia-Pacific region.

85. Query successful Based on the provided information, here are the details about the role and responsibilities of the Asian and Pacific Centre for Transfer of Technology (APCTT) as they relate to the pharmaceutical industry, in short points. Role Promotes Innovation and Technology Transfer: APCTT acts as a facilitator for the transfer and commercialization of new and emerging technologies, including those in the pharmaceutical sector. Strengthens National Capacity: It assists member countries in developing their abilities to manage national innovation systems and improve the terms of technology transfer. Fosters Regional Cooperation: The center promotes networks and partnerships among governments, R&D institutions, and private companies to facilitate the transfer of environmentally sound technologies and other innovations across the Asia-Pacific region.

86. Responsibilities Biotechnology and Traditional Medicine: The APCTT's initiatives have focused on creating networks like the Biotechnology Information Network for Asia (BINASIA) and the Asia-Pacific Traditional Medicine and Herbal Technology Network (APTMNET) to connect stakeholders in these fields. Information Dissemination: APCTT publishes knowledge products, such as the Asia-Pacific Tech Monitor, to share information on technological innovations, market developments, and relevant policies. Capacity Building: It provides training and workshops for policymakers and technology promotion institutions to enhance their skills in managing technology transfer projects and intellectual property. Matchmaking and Business Partnerships: The center hosts technology databases and platforms to assist technology providers and seekers in finding partners for joint ventures, research collaborations, and commercialization of technologies. Examples include requests for technologies to manufacture intravenous fluids, specific drugs like Methyl Cobalamine , and other pharmaceutical products.

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88. TIFAC TIFAC (Technology Information, Forecasting and Assessment Council) The Technology Information, Forecasting and Assessment Council ( TIFAC ) is an autonomous body under the Department of Science & Technology, Government of India. It functions as a think tank to guide and catalyze national initiatives in science and technology.

89. TIFAC These can include: Technology Assessment and Innovation Management Intellectual Property Rights (IPR) and related activities Administration & Finance Technology Foresight IT Cell

90. Technology Foresight Studies: TIFAC conducts studies to assess the current state of technology, forecast future trends, and identify potential challenges and opportunities for the country. This includes producing major documents like Technology Vision 2020 and Technology Vision 2035 . Innovation Support: It supports and funds technology innovation projects, particularly those involving Micro, Small and Medium Enterprises (MSMEs) .

91. Technology Commercialization : TIFAC helps in transferring technology from research labs to the market. For instance, it has implemented programs for the commercialization of homegrown technologies. Mission-Mode Programs : TIFAC has been involved in several mission-based programs aimed at a specific technological goal, such as the Fly Ash Mission and the Sugar Technology Mission . Capacity Building : The council trains scientists and other professionals in intellectual property rights ( IPR ) and technology management.

92. Policy Guidance : It provides a forward-looking perspective on technology to guide government ministries and departments in formulating their policies and plans. Bridge Between Academia, Industry, and Government : TIFAC facilitates collaboration and a symbiotic relationship between research institutions, industries, and government bodies. Problem Identification : The organization's studies and reports help to flag critical technology gaps and provide a holistic view of the technological landscape, enabling the government to respond effectively to global and national challenges. Promoting Indigenous Technology : A key role is to promote the development and use of indigenous technologies, thereby contributing to the vision of a self-reliant India (Atma Nirbhar Bharat).

93. TBSE Technology Bureau for Small Enterprises (TBSE) The Technology Bureau for Small Enterprises (TBSE) is an agency established to help small and medium-sized enterprises (MSMEs) in India access and adopt new technologies to improve their competitiveness. It functions as a platform to bridge the technology gap between MSMEs and global markets.

94. TBSE Connect Technology Suppliers and Seekers: TBSE identifies and connects MSMEs looking for technological upgrades with providers of new technologies from around the world. Promote Technology-Based Ventures : It helps small businesses establish joint ventures and business collaborations to leverage global technological opportunities. Build Confidence and Trust : It offers a professionally managed system to help build confidence and trust between potential partners during complex negotiations.

95. TBSE Technology Information: TBSE maintains an extensive computerized database of technology options from various countries, providing MSMEs with updated information on technology sources and how to access them. Matchmaking: It actively recognizes partners interested in collaboration and provides support to finalize arrangements for technology transfer and joint ventures. This includes assistance with drafting agreements and preparing business plans.

96. TBSE Finance Syndication: TBSE assists in arranging financing for technology projects through SIDBI and other financial institutions. Business Collaboration: It supports small enterprises in forming business tie-ups for the export of both technologies and their products. Support Services: TBSE provides a range of consultancy services, organizes meetings between buyers and sellers, and helps MSMEs represent their business interests at international events.

97. SIDBI SIDBI is the principal financial institution in India for the promotion, financing, and development of the Micro, Small, and Medium Enterprise (MSME) sector. Established on April 2, 1990, under a special Act of the Indian Parliament, it is under the jurisdiction of the Ministry of Finance, Government of India. 💰 SMALL INDUSTRIES DEVELOPMENT BANK OF INDIA

98. SIDBI Composition SIDBI's ownership and governance structure is diverse: Shareholders: The shares of SIDBI are held by the Government of India and over 20 other institutions, including public sector banks and insurance companies, like the State Bank of India ( SBI ), Life Insurance Corporation ( LIC ), and the National Bank for Agriculture and Rural Development ( NABARD ). Board of Directors: The Board is comprised of a Chairman & Managing Director , Deputy Managing Directors, and nominated directors from the Government of India and other key financial institutions. This ensures a broad representation of stakeholders.

99. SIDBI Principal Financial Institution: It serves as the apex body for regulating and licensing MSME finance companies. Credit Flow Facilitator: Its main mission is to facilitate and strengthen the flow of credit to MSMEs, addressing both financial and developmental gaps in the ecosystem . Promoter & Developer: Beyond financing, SIDBI undertakes promotional and developmental activities, such as training, capacity building, and supporting entrepreneurship.

100. Direct Financing: This involves providing loans directly to MSMEs for various purposes, including working capital, term loans, foreign currency loans, and support against receivables. It also has specific schemes for new entrepreneurs and for purchasing equipment. Indirect Financing (Refinance): This is SIDBI's main channel. It provides refinance to other primary lending institutions (PLIs) like banks and state-level financial institutions. This increases the resource base of these institutions, enabling them to extend more credit to the MSME sector. Developmental Activities: SIDBI adopts a 'credit plus' approach, which includes a range of non-financial services: Technology Upgradation: It helps MSMEs acquire and modernize their technology. Cluster Development: SIDBI supports the development of MSME clusters by improving infrastructure and providing other resources. Entrepreneurship Promotion: It provides support for budding entrepreneurs and helps in skill development.

101. TT related documentation -confidentiality agreement) Protect Intellectual Property (IP): Before a formal agreement (like a licensing agreement) is in place, parties need to evaluate the technology's potential. This requires sharing sensitive information like trade secrets, unpublished patent applications, know-how, and proprietary data. An NDA legally binds the recipient of this information to not disclose it to a third party or use it for any purpose other than the agreed-upon evaluation. Maintain Patentability: Public disclosure of an invention can often destroy its novelty and lead to the loss of patent rights. An NDA ensures that the information shared remains confidential, preserving the right to seek patent protection later. Establish Trust: It creates a framework of trust that allows for open discussions and the exchange of information, which is essential for parties to assess if a technology transfer deal is viable.

102. TT related documentation -confidentiality agreement) Identification of Parties: Clearly states the names and addresses of the disclosing party (the owner of the technology) and the receiving party. Definition of Confidential Information: This is the most crucial part. It must precisely define what constitutes "confidential information." This can be a broad or specific list that includes: Technical data, know-how, and trade secrets. Unpublished research and development data. Financial information, business plans, and customer lists. Formulas, designs, and processes.

103. OBLIGATIONS OF THE RECEIVING PARTY: Outlines what the receiving party must do to protect the confidential information. This includes: Maintaining the information in strict confidence. Using the information only for the stated purpose of evaluation. Limiting access to the information to employees or consultants on a "need-to-know" basis, who are also bound by confidentiality. EXCLUSIONS FROM CONFIDENTIALITY: Information already in the public domain. Information that the receiving party already possessed before the agreement. Information lawfully obtained from a third party without a breach of confidentiality. Information independently developed by the receiving party without using the confidential information.

104. TT MOU A Memorandum of Understanding (MOU) in the pharmaceutical industry serves as a preliminary, non-binding agreement between two or more parties before a formal contract for a technology transfer is finalized. Its main purpose is to outline a framework of cooperation and mutual goals.

105. PURPOSE Signals Intent: It demonstrates a mutual, serious intention to enter into a more detailed, legally binding agreement later. Outlines a Framework: It defines the scope of the technology to be transferred, the roles and responsibilities of each party, and a general timeline. Non-Binding: The key characteristic of an MOU is that, unlike a definitive contract, it is generally not legally enforceable . This provides flexibility for both parties to negotiate without being locked into the terms. Basis for Negotiation: The MOU acts as a roadmap for drafting the final, legally binding Technology Transfer Agreement (TTA) , which will include specific details on intellectual property (IP), financial terms, and other legal obligations.

106. PURPOSE Parties Involved: Clearly identifies the organizations entering into the agreement and their respective roles (e.g., the "sending unit" and the "receiving unit"). Subject of the Transfer: Specifies the technology to be transferred. This might be a specific drug formulation, a manufacturing process, or a new analytical method. Scope of Work: Provides an overview of the activities to be performed by each party. This could include process development, scale-up, validation, and training. Confidentiality: This is one of the most critical parts. The MOU will often incorporate or reference a separate Non-Disclosure Agreement (NDA) to protect sensitive technical, regulatory, and commercial information shared during the negotiation and evaluation phase.

107. LICENSING IN TECH TRANSFER A licensing agreement is a legally binding contract that formalizes the terms of the technology transfer. While each agreement is unique, they generally contain several key components: Definition of Technology : A precise description of the technology and the specific intellectual property rights being licensed (e.g., patents, trademarks, copyrights, know-how, and trade secrets).

108. Exclusivity : Is the license exclusive (only the licensee can use the technology), non-exclusive (the licensor can license to multiple parties), or sole (only the licensee and the licensor can use the technology)? Field of Use : Specifies the market or industry where the technology can be used. Territory : Defines the geographic region where the licensee can operate.

109. Exclusivity : Is the license exclusive (only the licensee can use the technology), non-exclusive (the licensor can license to multiple parties), or sole (only the licensee and the licensor can use the technology)? Field of Use : Specifies the market or industry where the technology can be used. Territory : Defines the geographic region where the licensee can operate.

110. Invention Disclosure : An inventor or research team formally discloses their new technology to the TTO. Assessment : The TTO evaluates the technology’s market potential, novelty, and patentability. This may include a prior art search to see if the invention is truly new. Protection : If the technology has commercial potential, the TTO works to protect the IP, often by filing a patent application. This step is critical as public disclosure without protection can forfeit patent rights. Marketing : The TTO creates a non-confidential summary of the technology and markets it to potential licensees in relevant industries. Negotiation : An interested company contacts the TTO, and negotiations begin. This is often preceded by a Confidentiality Agreement (NDA) to allow for the sharing of sensitive information. Agreement : Once both parties agree on the terms, the final licensing agreement is drafted and executed. The technology and know-how are then formally transferred.

111. The Ultimate Goal: 🛡️ Patient Safety Ensuring consistent quality and efficacy, regardless of where a drug is made. 🌍 Global Harmonization Streamlining approvals and access to medicines across international markets. 💡 Accelerated Innovation Bringing life-saving medicines from the lab to the public faster and more efficiently.

112. National Research Development Corporation (NRDC) Promotes the commercialization of indigenous technologies from public R&D labs. NRDC's role is vital for: • ✔Patenting & Licensing of Innovations • ✔Transferring Lab-Scale Inventions • ✔Fostering Academia-Industry Links

113. QUALITY RISK MANAGEMENT The Quality Risk Management Playbook A proactive, systematic approach to ensuring patient safety throughout the pharmaceutical product lifecycle, as guided by ICH Q9. Why QRM is Non-Negotiable Quality Risk Management (QRM) moves beyond reactive quality control to a proactive, science-based mindset. It's a fundamental shift in how the industry ensures product quality and, ultimately, protects patient health.

114. RISK ASSESSMENT/MAAGEMENT TOOLS RISK CAN BE MINIMISED/CONTROLLED BUT NOT BROUGHT DOWN TO ZERO

115. Case Study: FMEA for Equipment Failure Failure Mode and Effects Analysis (FMEA) is a powerful tool to quantify and prioritize risks. Here, we analyze a critical pump on a drug formulation line to determine its Risk Priority Number (RPN).

116. LINK TO THE DOCUMENT https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/production/trs961-annex7-transfer-technology-pharmaceutical-manufacturing.pdf?sfvrsn=2e302838_0