Critical Quality Attributes for Live Viral Vaccines. Mark S. Galinski Vaccine Analytical Sciences, MedImmune, Mountain View, CA USA
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1 Critical Quality Attributes for Live Viral Vaccines Mark S. Galinski Vaccine Analytical Sciences, MedImmune, Mountain View, CA USA
2 Terminology Quality Release Standards The specifications and procedures applicable to an establishment or to the manufacture or release of products, which are prescribed in the Code of Federal Regulations (CFR) or established in the biologics license application (BLA) to assess the product Prescribed by FDA regulations or contained in the BLA are designed to ensure the safety, purity, and potency, stability and sterility (if applicable) of biological products 2
3 Terminology Cont d Quality Attributes Physical, chemical, or biological property or characteristic of a material that directly or indirectly impacts quality Critical Quality Attributes (CQAs) A quality attribute that must be controlled within predefined limits to ensure that the product is acceptable for its intended use. > Meets safety, purity, potency, stability, and clinical performance Critical Process Parameters (CPPs) A manufacturing process parameter that must be controlled (predefined limits) to ensure the product meets its quality attributes 3
4 Vaccines Vaccines are biological products that stimulate the immune system to protect against or prevent a disease Immunity can be antibodies, cellular immune responses, or both, Vaccine products from a variety of microorganisms and viruses have been prepared using different methods of manufacture Inactivated microorganisms (microbial or viral) Live attenuated microorganisms (microbial or viral) Subunit proteins and/or polysaccharides (microbial or viral) Recombinant-derived attenuated or replication incompetent viruses Recombinant DNA expression vectors 4
5 Commercial Viral Vaccines LVV: Live Viral Vaccine TIV: Traditional Inactivated Vaccine Sub: Subunit Vaccine Viral Type 1 Adenovirus LVV 2 Hepatitis A TIV 3 Hepatitis B Sub 4 HPV Sub 5 Influenza LVV, TIV 6 Japanese encephalitis TIV 7 Measles LVV 8 Mumps LVV 9 Poliomyelitis LVV, TIV 10 Rabies TIV 11 Rotavirus LVV 12 Rubella LVV 13 Smallpox LVV 14 Varicella LVV 15 Yellow fever LVV 5
6 Live Virus Vaccines (LVV) LVVS are complex biological products API is an infectious (replicating) virus Adenovirus Influenza Mumps Rotavirus Varicella-Zoster 6
7 Live Virus Vaccines (LVV) Manufacturing processes are complex biological systems with minimal downstream processing Well characterized cell substrates Well characterized virus stock seeds RM with minimal or no animal derived products Terminal sterilization is not always performed > Aseptic processing requirement Products given to healthy subjects to prevent disease Tolerance for any AE is low 7
8 MASTER SEED TO VACCINE Upstream Processing Master Virus Seed Critical Quality Attributes Quality Potency Safety Efficacy Stability Manufacturer s Working Stock Seed Harvested Virus Single Harvest Multiple Harvest Pool Bulk Virus Vaccine Drug Substance Final Formulation Drug Product Downstream Processing 8
9 MASTER SEED TO VACCINE Two-Tiered Seed System Master Virus Seed (MVS) Manufacturer s Working Stock Seed (MWSS) Harvested Virus Single Harvest Multiple Harvest Pool Virus Seeds Bulk Virus Vaccine Drug Substance Manufacturing Cell Substrate Final Formulation Drug Product 9
10 Master Cell Bank to Vaccine Cell Substrate Two-Tiered Cell Banking System Master Cell Bank (MCB) Manufacturer s Working Cell Bank (MWCB) Cell Expansion Manufacturing Cell Substrate Virus Manufacturing MVS MWVS Bulks Virus Seeds 10
11 VACCINE MANUFACTURING CQA s Cell Substrate What CQAs must be controlled to ensure that the product is acceptable for its intended use? Cell Substrate (MCB, WCB, EOP) Purity sterility, mycoplasma, mycobacteria, in vitro/in vivo adventitious agent testing, PERT, co-cultivation indicator cells, PCR amplification select agents Safety Tumorigenicity, DNA oncogenicity, risk assessments TSE-BSE Characterization Identity, karyology, morphology, TEM, Population Doubling Level (PDL) for vaccine manufacture, senescence PDL 11
12 VACCINE MANUFACTURING CQA s MVS MWSS What CQAs must be controlled to ensure that the product is acceptable for its intended use? Master & Working Stock Seeds Purity Sterility,mycoplasma, mycobacteria, in vitro/in vivo adventitious agent testing, PERT, co-cultivation indicator cells, PCR amplification select agents Safety Attenuation, phenotype, absence of neurovirulent activity Characterization Identity, morphology, genome sequence, genetic stability 12
13 Bulk Vaccine Manufacturing Cell Substrate Expansion Vial Cryopreserved Cells Cell number, viability following recovery, stability LN2 Cell Substrate Expansion C for cell growth, cell plant density (cells/cm²), cell harvest, viability, PDL, confluency (%) Bioreactor Plant Control Cells C for cell growth, cell plant density (cells/cm²), PDL, confluency (%) 13
14 Bulk Vaccine Manufacturing Virus infection (MWVS) MWVS Cryopreserved MWVS PFU/TCID 50 /FFU per ml, stability -60 C or lower Infect Bioreactor Cell Substrate Day post-plant cell substrate, multiplicity of infection, C for virus adsorption/growth, culture medium Control Cells Treat as bioreactor except no virus infection 14
15 Bulk Vaccine Manufacturing Harvest Virus Fluids Harvested Virus Fluids Day post-infection Sterility, extraneous agent testing, potency Stabilizer addition Sterility, potency Control Harvested Fluids Day post-infection Absence cytopathic effects Sterility, extraneous agent testing Stabilizer addition Sterility Direct cell substrate hemadsorption testing Identity 15
16 Bulk Vaccine Manufacturing Downstream Processing HVF Harvested Virus Fluids Simple Downstream Processing Pooling (multiple harvests or sublots) Filtration (removal of intact cells) Dispense Drug Substance & Freeze Potency Identity Volume, freezing rates, -60 C or less Stability Harvested Virus Fluids Complex Downstream Processing UF, DF, TFF, Ultracentrifugation CQAs process dependent: flux, exchange volumes, time, density, temperature, x-gravity, etc. Sterilization (bioburden) Potency Dispense Drug Substance & Freeze Potency Identity Volume, freezing rates, -60 C or less Stability 16
17 Bulk Vaccine Manufacturing Drug Substance Manufacturing Process Residuals Residuals ae typically measured in bulk to meet final container specification Host cell Cell protein DNA Ovalbumin Culture medium components Fetal/calf bovine serum Neomycin Process Contaminants Downstream processing components Benzonase Materials of construction (chromatography or membrane) leachates 17
18 Final Filled Vaccine Manufacturing Drug Product Final Formulated Bulk (Excipients & Vaccine Bulk) Excipients Provide for product stability (ph control, protein stability) Proteins such as gelatin, human serum albumin, recombinant proteins Sugars, amino acids, inorganic salts Formulation Parameters Component volumes, order of addition, mixing time/speed, temperature, potency of FFB Target post-fill potency reflecting loss on formulation Stability 18
19 Final Filled Vaccine Manufacturing Drug Product Final Container Filling Container and closure Glass vial, syringe, stoppers, (product contact) Filling Parameters Volume Potency Stability Materials of construction, leachates, lubricants, closure (lyophilization) 19
20 Final Filled Vaccine Manufacturing Drug Product Final Container Lyophilization Freezing rate, lyophilization parameters for primary and secondary drying Elegance (cake quality) Moisture Stability Photosensitivity Potency (process target) Liquid Stable Clarity Stability Photosensitivity Potency (process target) 20
21 Final Filled Vaccine Manufacturing Drug Product Final Container Product Release Testing Potency (minimum/maximum release potency) Sterility General Safety Volume (to deliver) Identity Color & appearance Osmolality Total protei Final Container Stability Container closure Sterility Long-term real-time Intermediate storage (-25 C or less) Market-released storage (2-8 C or frozen) 21
22 Final Filled Vaccine Manufacturing Drug Product Final Container Stability Container closure Sterility Long-term real-time Intermediate storage (-25 C or less) Market-released storage (2-8 C or frozen) Final Container Stability Container closure Sterility Long-term real-time Intermediate storage (-25 C or less) Market-released storage (2-8 C or frozen) 22
23 Summary Manufacturing processes are complex biological systems with minimal downstream processing Well characterized cell substrates Well characterized virus stock seeds Control of al all RMs Process consistency to reproduce drug product and drug substance from lot-to-lot Potency is the key biological measure of the product 23
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