13-Technological Advances in Manufacturing of Plasma Derived Medicinal Products(PDMPs)_Dr. Ranjeet S Ajmani.pdf

Technological advances in PDMP manufacturing

1. Dr. Ranjeet S Ajmani
Chief Executive Officer : Asia
Aegros, Australia
[email protected]
Technological Advances in Manufacturing of
Plasma Derived Medicinal Products (PDMPs)

2. Science and Technology
§Discovery Vs Invention
§Science :
§Understanding natural process in granular details
§Journey of Unknown /s
§Academic
§Technology :
§Function of time
§Social relevance
§ impact

3. Technology : Evolution and Need
§Science, research and discovery :
§Expensive,
§Affordability
§Time consuming
§IPR- Limited
§Technology : Relatively quicker adoption and global impact


Knowledge and Technology : Biggest Social
Equalizers

4. HistoricalView : II World War

5. Cohn’s Laboratory shipped human serum Albumin to treat casualties of the
Pearl Harbor attack Dec 7, 1941.
Historical View

6. 1941-2024: Conflict Ukraine -Russia

7. Cohn
§Pioneer work
§Separation of proteins- low pH, low temperature,
Alcohol, ionic strength
§Saved many lives and started new concept

But……………. In absence of
§Well structured donor recruitment program
§A well tested plasma @ donor level
§Viral Inactivation protocols at manufacturing level
Erupted to a Global Tragedy …………

8. AIDS – Global Tragedy

9. Public Health Issue: New Viruses
Screening of known agents : Threat of unknowns

10. How viral transmission can happen ?
10
Batch of 2500 LBatch of 5000 L
250 ml
10000 Bags20000 Bags
Chances of one bag being
contaminated/escaped safety
net or Sero Conversion

11. Process and Impact
§One raw material – Many products
§Albumin
§IVIG
§Factor VIII
§Factor IX
§Fibrinogen
§Thrombin
Consumed by one patient- impact family …………….., social life,
professional commitment, public healthcare burden

13. Technology Level: PDMPs
Raw Material:
§Plasma – Recovered, Source, Hyper Immune
§Plasma Storage : FFP, CPP, DDP. NHP etc.
§Plasma bar coding : Under estimated
§Plasma Testing : ELISA, Chemi PCR/NAT.
§Quantity : 1 L vs 80 L/Year
Manufacturing :
§Cohn
§Hybrid
§Chromatography
§Recombinant
§Hemofract
Viral Safety :
§Look back period
§Pool testing : Small, intermediate and manufacturing
§Two / Three steps of Viral Inactivation or removal

14. DonorDonation Blood
Storage
Manufacturing
(first stage)
Viral SafetyFinal
Manufacturing
Finished
Products
Patients
Safety Step : 1
screening
(Questionnaire / Interview
Hemoglobin, Physical Examination
Safety Step : 2
Viral Testing
*HIV – I & II
*Hepatitis – C & B
*Malaria
*Syphilis
Safety Step: 3
Inventory
/Back
Tracking
Safety Step: 4/5
4 Quality Assurance
5 GMP
Safety Step: 6
Inactivation and/ or Removal
Safety Step : 7
Good Clinical
Practice
Safety Step: 8
Post Marketing
Surveillance and
Hemovigilance
Flow Chart of PDMPs

15. “
Of all the forms of inequality,
injustice in healthcare is the most
shocking and inhumane” Rev Dr.
Martin Luther King Jr.
“The richest countries are getting 30
times faster vaccinated than lower
incomes : This vaccination gap is not
just unfair, it threatens everyone”
Antonio Guterres, SG- UN
1965 Vs 2021 ?

16. Country of Sharp Contrast

17. Affordability- Technology Implementation
vProducts from Western Source à Not affordable in
Asian scenario :
vPoor health insurance coverage à High Out-of-Pocket
Expenditure
vLower average income
vLack of govt. support - healthcare expenditure, social
security etc.
vLack of Patient Support Groups & lobbying

18. Harmony and Coexistence