10 Key Studies to Secure a Successful BLA Submission

‘The process is the product’ occupies the mind of any biologics developer aiming to file a successful Biologics License Application and avoid post-marketing monitoring stumbling blocks.

A significant portion of costly BLA approval delays result from either insufficient detail that prohibits the FDA from replicating an analytical method or from analytical data gaps that create doubt that the assembled analytical package is sufficient to understand and control all critical quality attributes (CQAs) throughout the manufacturing process. Because biologics are complex molecules typically derived from living cells, carefully designed and validated manufacturing processes are essential to regulate the product’s CQAs to ensure they are controlled, consistent, and replicable from lot-to-lot.

To support this, extensive product characterization and analytical methods are required and applied to process optimization and final product samples; thereby making the analytical program from start to finish arguably the most critical aspect of a successful BLA filing.

Fortunately, approval delays can be avoided by partnering with an advanced analytical expert laboratory such as ProtaGene. Seven key BLA-supporting studies and three essential post-market monitoring programs are mentioned here as examples of our applied analytical expertise:

BLA Support Studies

1. BLA-Stage Forced Degradation Program with Isoform and Low-Level Impurity Isolation and Characterization

2. Complex O- and N-Linked Glycosylation Profile and Site Mapping for Lot Comparability

3. Detailed Product Full Sequence and PTM Comparability for Manufacturing Change/CMO Bridging Studies

4. Closing Gaps in Method Validations and Historical Clinical Lot Comparability

5. Conformational and site-specific PTM correlations to Structure/Function under varying Process Changes

6. In Vivo critical quality attribute analysis based on isolation and analysis of drug from patient serum

7. HCP Characterization, evaluation of control ELISA security and Process Clearance Monitoring via LC-MS

Post Market Monitoring

8. Commercial Lot Characterization and Attribute Monitoring under improved Qualified Methods as Product Lifecycle Management Program

9. Post Marketing Accelerated/Forced Degradation Testing

10. Adverse Event or Out of Specification Analytical Support/Investigations

Drug developers face a complex and difficult-to-predict journey, so they must prioritize their resources to meet pipeline and commercialization objectives while acknowledging resource constraints. To avoid over- or under-resourcing their analytical departments, innovator teams are turning to ProtaGene. We are a collaborative analytical partner that can seamlessly integrate with our clients’ in-house analytical teams, allowing rapid scale-up or scale-down of analytical resources.