Technology transfer plan & exhibit

Information of Technology Transfer plan and exhibit

1. Technology transfer plan & exhibit Presented by- Akshay Prakash Nehe Final year B pharmacy, AVCOP Sangamner Sem -7 Roll no. 52

2. Technology transfer Technology transfer is very common in pharmaceutical manufacturing but is often taken for granted, which can led to production problems and increased costs. This presentation describes various steps for performing a successful technology transfer

3. Transfer of technology TOT- A logical procedure that controls the transfer of an established process together with its documentation of professional expertise to site capable of reproducing the process and its support functions to a predetermined level of performance Ref no. 2

4. Flowchart of technology transfer in pharmaceutical industry Ref no. 5

5. Technology transfer plan The TT plan is to describe items & contents of technology to be transferred, and detailed procedures of individual transfer & transfer schedule establish judgment criteria for the completion of the transfer. The transferring party should prepare the plan before the implementation of the transfer & reach an agreement on its contents with the transferred party The Report- Both transferring & transferred parties should document the TT report The exhibit- After taking scale-up batches of product, manufacturing of exhibit batches takes place. In case of exhibit bathes sizes are increased along with equipment & their processes This is done for filing purpose in regulatory agencies Ref no. 6

6. Tech transfer documentation steps 1 st documentation step Purpose- to provide a general framework for a tech transfer & details its scope Should include description of teams, stakeholders, changes Tech transfer’s success criteria The tech transfer package should contain as much information as necessary to ensure that the receiving unit can successfully complete the tech transfer on time and within budget Implementing a risk assessment strategy and mitigating those risks will bring a robustness to the transfer process & ultimately prepare it for validation Detail execution of every important steps & various activities

7. Need of technology transfer The developer should not be financially sound to require discovered drug to the whole development because it includes various steps. In such cases, the collaboration of the developer with a corporation is needed so the invention could reach to the market. If demand rises for the product then with collaboration within developer & producing units to induce reciprocally benefitted . - Points with respect to actual technology or process developer. Importance of Technology Transfer It leads to the economic expansion of pharmaceutical industry influencing the economic performance of the nation It leads to collaboration of science and business which may result in the introduction of a new drug or health tool to the market It is critical process which results in transferring the scientific findings of the research labs to be available to the commercial units Ref no. 3

8. Technology Transfer Team Controlling temp, pressure of particular area Calibration status of machines & equipment Key persons To make a bridge between research technologist & manufacturing unit Cross verify instructions provided by QA personnel’s Confirm capacity & capability of manufacturing unit Setting up testing procedures & testing specifications Validating methods with QA personnel Check & update equipment status Quality testing of formulation, post manufacturing Perform final review including Equipment qualification Testing procedures Conducting validation Stability studies Release of formulation to commercialization Getting ready general info regarding formulation within kind of written format - Dossier Ref no. 4

9. Technology Transfer protocol The TT protocol should list the intended sequential stages of the transfer. The protocol should include; Objective; Scope; Key personnel & their responsibilities; A parallel comparison of materials methods & 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 & acceptance criteria for analytical methods Info on trial production batches, qualification batches & process validation; Change control for any process deviation encountered; Assessment of end product; Arrangements for keeping retention samples of active ingredients, intermediates and finished products & info on ref substances where applicable. Conclusion, including signed-off approval by project manager. Ref no. 2

10. Planned transfer activities Pilot batches To perform functionality characterization of the active ingredient & critical excipients Manufacturing of small pilot batches to confirm feasibility of product using API & excipients that receiving unit should using. Stability batch Based on recommendation of technical report, company manufacture stability batch to issue manufacturing/packaging protocol, batch reports as well as stability protocol Evaluate & confirm critical process parameters & implement in-process testing controls during stability batch Scale up Scale up refers to rise within batch size of the product Product generated at this stage to access qualification & determine whether a new tooling or packaging configuration is required or not Other studies Perform a process validation, cleaning validation/validation, bulk holding time, and packaging validation studies A report generated by this studies is needed for filing to restrictive agencies. Ref no. 1

11. Examples side-by-side process comparison Sending unit Receiving unit Pre-blend Screen excipient A & B through a #12 mesh screen using a Sweco screener. Blend both for 5 minutes in a 10-cubic-foot V-blender. Blending Screen excipients C & D and API through a #12 mesh screen using a Sweco screener. Add Excipients C, D, and pre-blend between two equal parts of API. Mix for 10 minutes in a 60-cubic-foot V- blender with intensifier bar operating Compression Compress tablets on a Korsch XL400 tablet press at 42-50 rpm (88,200-105)tablets per hour. Tablet core is a 3/8- inch round, flat, beveled tablet with a “C” logo embossed on one side and “250” on the reverse Pre-blend Order of addition, hand versus automated mixing and screening, screen size, type and size of equipment, mixing time Blending For each blending step: order of addition, ingredient quantities, screen size, mixing time, mixing speed. Compression Model and make of tablet press, compression, speed range, description of logo on both sides. Ref no. 1

12. Example of initial risk management Item Level of change Risk Risk mitigation Active ingredients Major Will use different supplier of directly compressible active ingredients granulation Tested lots from three suppliers for chemical & physical properties. Will conduct pilot plant studies. Excipients Minor Will use the same suppliers Sources were already qualified at receiving site. Composition/formulation Minor Change to % of lubricant used within SUPAC limits Will monitor sticking issues during pilot plant. Batch size Minor RS will run a similar batch size to that of the sending site within EWV Will perform blend-time studies on pilot & scale up batches. Major equipment Moderate Moving from a high shear blender to a V-blender Will perform-/-batches to confirm the uniformity of final blend

13. Item Level of change Risk Risk mitigate In-process controls Minor Will maintain same or more stringent in-process controls Will confirm in-process controls in pilot and scale-up studies. Analytical test methods – Raw materials and finished products None No changes planned or will use USP methods Will verify all the compendial methods. Will transfer finished products. Finished product specifications None No changes planned Will use the same release specifications Stability Primary packaging components None Moderate No changes planned Planning to change the bottle supplier. Will use the same type of resin but from different supplier Will use the same stability specifications Will perform accelerated & long-term stability studies on pilot study batches Ref no, 1

14. TT agencies in India Asian & Pacific center for transfer of technology (APCTT) National Research Development corporation (NRDC) Technology information, Forecasting and assessment Council (TIFAC) Biotech Consortium India Limited (BCIL) Technology Bureau for Small Enterprises (TBSE) Small Industries Development Bank of India (SIDBI) Ref no. 2

15. Success of technology transfer “C” Ref no. 3

16. Barriers of technology transfer The basic challenges faces by the organization while transferring the technology can broadly be defined as Economic factors Poor business administration , lack of business agreement, lack of pre risk management Technical factors The difference in the infrastructure of research lab and manufacturing unit leads to technical issues Miscellaneous factors Inadequate funding in imp areas like research centers leads to incompetent results Labour issues In pharma sector highly skilled and experienced persons are required , lack in their no. may results in low production Ref no. 4

17. Successful TT example Eli Lily has entered in technology transfer agreement with Shasun chemicals & Drugs for the manufacturing of Anti TB drug CYCLOSERINE produced by Shasun to meet Eli Lily global demand Conclusion A tech transfer plan is a living document that captures all activities & changes & risk involved in a technology transfer, A valuable tool that a project manager or a technical lead maintains from the project inception up to the completion of all activities TT can be considered successful if a receiving unit can routinely reproduce the transferred product, process or method against a predefined set of specifications . Technology transfer provides an opportunity to reduce cost on drug discovery & development thus major pharmaceutical companies look for technology transfer opportunity as it reduces risk, cost , & rate of failure Ref no. 6

18. Reference Technology transfer, by Anthony grenier, Copyright @CSE publishing March 2019 Tablet & capsules Study material by Dr. N. Patra BP 702 T. Industrial pharmacy II Technology transfer in pharmaceutical industry; transfer of process from development to commercialization : IJPSR (2013), vol. 4, issue 5 review article by Rahul dogra, Rajeev garg & Prakash jadhav TT: An overview process, review article by K. Pandey, H. Joshi.., published @IJCPR in 2018 Technology transfer; case studies from real world, @PDA Israel, by Ofer Dublinsky in March 2019 Technology transfer in pharmaceutical industry by K. Amneet, Sharma o. p R&D dept in morepen labs @IJCPR in 2013

19. Thank you