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Vaccine

Attenuated, Inactive, Subunit Vaccine

Vaccines provide active acquired immunity to diseases. Since vaccines are directly given to healthy populations, R&D and production of vaccines demand extremely stringent biosafety requirements. A closed-loop quality control system spanning the entire workflow- from raw material control and process monitoring to product release- must be established to comprehensively reduce biosafety risks.

Biosafety Strategy for Cell and Gene Therapy

Vaccine

Viral Seed Characterization

Virus bank manufacturing is a critical step in producing biopharmaceuticals like vaccines and CGT.

Biosafety Consideration of Virus Bank Manufacturing

Master and Working Virus Seeds Stocks provide the foundational viral material for generating viral vectors or vaccine candidates (live-attenuated/inactivated viruses). To ensure downstream manufacturing success, virus banks must preserve identity, quality, and stability while strictly complying with cGMP standards and regulatory guidelines (FDA/EMA/ICH). It is important to ensure there is no bacterial, fungal, mycoplasma, or adventitious viral agent contamination is present. Therefore, safety testing is essential during the manufacturing process of CGT and vaccines.

Regulatory requirement

All viral seed stock shall be characterized according to the requirements of European Pharmacopoeia 2.6.16 and FDA2010 Guidelines for the management and quality control of bacterial/viral seed banks. Regulations require the use of neutralizing antiserum for post-neutralization tests.

BRC Solutions for Microbial Bank Characterization

The sponsor should provide the neutralization titer required by the corresponding antiserum and antiserum, while showing that the antiserum is free of contamination. If neutralizing antisera is not available, molecular assays can be performed using NAT (PCR and NGS) or using control cells.

Testing for Working Viral Seed Stocks

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