LBP cGMP Characterization and Stability: Designing an Effective Testing Program on the Road to Commercialization

Once the science has determined the production strains targeted to treat the disease indication, there are many regulatory hurdles that must be overcome on the path towards clinical trials, and ultimately commercialization. Setting up an effective, compliant release testing and stability regimen is paramount.

This talk provides detailed background on the following:

• Evaluation of successful clean room commissioning, with both microbial ingress and egress considerations specific to LBP manufacturing.

• Cell culture and raw material characterization programs

• Assay design and validation of viability-based titer and identification assays with molecular technologies.

• Cold Chain Transport stability program design and execution; ensuring testing regimens are timely and accurate when dealing with a living product.

• Release testing in support of clinical trials and IND filings

• Building upon biologic manufacturing and testing practices to characterize LBP drug substance and drug product.

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