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 a 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.
Presenter: Jeff Heiser, Director of the Microbiology Laboratory and Kathleen Brennan, Associate Director of the Microbiology Laboratory
Jeff's Bio: Jeff Heiser is the Director of Microbiology at Boston Analytical. He oversees the operation of the lab in release/stability testing, validation, and Environmental monitoring. Jeff received his B.S. in Microbiology from the University of New Hampshire and worked at both Pfizer Biotech in Andover, MA and Genzyme Biosurgery in Cambridge, MA prior to joining Boston Analytical as a Microbiologist in 2012. Jeff is a leader in the cGMP characterization of anaerobic Live Bioptherapeutic (LBP) medicines where the active is a bacterial cell. Over the past 15 years, Jeff has worked to develop routine testing processes and has actively participated and led the implementation of Instrument and Method Validation as well as rapid microbiology instrument evaluation studies.
Kathleen's Bio: is the Associate Director of Microbiology at Boston Analytical. She received her B.A. in Biology from Hartwick College in Oneonta, NY. Before joining Boston Analytical in 2016, Kathleen worked at Lonza Biologics in Portsmouth, NH, and Shire in Lexington, MA, in the QC Microbiology groups. At Boston Analytical, Kathleen oversees the quality of the Microbiology group, with a focus on laboratory investigations and continuous improvement projects.