Recombinant Protein
Growth Factor, Insulin, etc
Recombinant protein therapies – including major biologics like monoclonal antibodies – are produced by inserting target DNA into bacterial or mammalian host cells, expressing the encoded proteins, and purifying them from cellular systems. Widely used as host, Escherichia coli (E. coli) plays a key role in recombinant protein production. There have been various approved therapeutic proteins produced in E. coli, contributing to the low cost. Despite these advantages, the production process is complex and requires strict control over key indicators such as host residuals and process impurities. BRC Bio offers quality testing for E. coli and plasmid products, meeting the requirement of gene therapy, gene-modified cell therapy, vaccine, nuclear acid drug etc.
Biosafety Strategy for Cell and Gene Therapy
Microbial Bank 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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