Case Study

Do Your BioPharma Analytical Methods Hold Up To Regulatory Scrutiny?

Do Your BioPharma Analytical Methods Hold Up To Regulatory Scrutiny?

By Jon S. Kauffman Ph.D., Senior Director, and Cynthia Eby, Principal Technical Specialist/Group Leader, Protocol Development and Technical Support

As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are even facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe. This exercise requires significant amounts of time and resources, which many manufacturers do not have since they are focused on getting their next products to market. For that reason, some clients have been turning to Eurofins Lancaster Laboratories for support.