Microbiome-Based Therapies: Setting up a cGMP compliant program within current regulatory frameworks
The microbiome has opened up new frontiers for the treatment of many human disease indications. After the science has determined the drug product targeted to treat the disease indication, there are several 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:
- Microbiome Product specific considerations for cGMP compliant testing and manufacturing
- Evaluation of successful clean room commissioning, cold chain transport and stability testing 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
- 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.To view webinar, please click here.