Biosafety Testing

Biosafety testing is a foundational requirement in the development and manufacturing of biologics, including monoclonal antibodies, ADCs, cell and gene therapies, and mRNA products. It ensures that products are free from contamination and meet quality standards necessary to protect patient safety. However, biosafety testing is complex, time-intensive, and expensive, with complete characterization of cell banks costing up to $200,000 and requiring months of testing.

Critical stages in the biosafety journey include cell bank testing, unprocessed bulk testing, viral clearance studies, and final product testing. Each stage has unique challenges. Cell bank testing must detect contaminants like mycoplasma and viruses and often lacks comprehensive documentation, especially in legacy systems. Unprocessed bulk testing helps detect contamination introduced during manufacturing and informs viral clearance strategy. Viral clearance studies validate the effectiveness of contaminant removal and are required before clinical trials, but are costly and technically demanding. Final product testing ensures sterility, potency, and purity, while stability testing determines shelf life under various storage conditions.

Strategic planning is vital to balancing cost, efficiency, and compliance. Alternative detection methods like PCR and NGS are gaining traction but bring their own technical hurdles. Challenges include sample volume requirements, assay validation, and evolving regulatory expectations. Risk-based approaches, collaboration across the value chain, and expertise in interpreting data and navigating regulations are essential to success.

Ultimately, effective biosafety testing supports patient safety, regulatory approval, and commercial success while avoiding costly failures and development delays.