This workstream is driving application of effective microbial control strategies for manufacturers of low-bioburden bulk biologics and developing associated best practice guidance.
Regulatory attention is intense and current guidance is not comprehensive
During site inspections and BLAs Regulators are closely scrutinizing bioburden controls during site inspections and BLAs and companies are feeling increasingly exposed. The issue is compounded by gaps in the guidance for biotech products. Automated methods are proving awkward to validate and commercialize. Regulators are expecting a higher level of demonstrated control and different agencies have different expectations, leading to high regulatory risk.
Establishing industry protocols to eliminate microbial contamination issues
Members are working towards harmonized industry protocols to address immediate issues, optimize validation and robust operation of micro methods and eliminate microbial contamination issues in production processes.
By addressing subjects of concern to regulators, feedback during regulatory inspection will be more positive and reduce risk to license to operate. It will also result in higher process capability, better data integrity in micro labs, improved quality and improved compliance. Achieving 100% microbial contamination prevention will reduce the cost of poor quality.
Microbial Control deliverables
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Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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