ACF Bioservices, a division of Absorption Systems, recently participated in The Bioprocessing Summit in Boston to showcase our developing advancements in the Cell & Gene Therapy space.
The Bioprocessing Summit convenes international bioprocessing professionals to share practical solutions for today’s challenges. The event holds many multi-track conferences and short courses with week-long programming on a vast array of bioprocessing topics including cell and gene therapy products.
Regenerative Medicine has begun to exit its infancy and take hold of major healthcare markets worldwide. The possibilities inherent in cell and gene therapy research make it one of the most exciting and relevant developments in biotechnology today. Both the FDA and EMA have clearly stated that the submission of a new cell or gene therapy, for late-stage clinical trials or commercial product release, require testing to verify the mechanism by which the therapy works. Meaning they’re specifically looking for potency assays.
Prior to the development of ACF, Absorption operated mostly in small molecule therapeutics. For the last 20 years we have been performing in vitro potency assays as recommended by FDA to determine the inhibition potency of investigational drugs for transporter and metabolism-mediated interactions. ACF’s purpose is to operate as a new division that focuses on large molecules and cell and gene therapy services. In doing so, ACF has established a dedicated and access-controlled space for GMP potency and release assays to meet regulatory requirements. While attending this year’s Bioprocessing Summit, ACF’s Karen Doucette was able to speak to these recent developments in her presentation: “Steps to Validate an In Vitro Relative Potency Assay for Gene Therapy Products”.
Validating potency assays for gene therapy products has unique challenges not relevant to other biological products, making the process more complicated. For instance, potency of a gene therapy vector is based on two biological activities: transgene expression and functional activity. Both of these endpoints must be quantifiable and validated prior to submission. Gene Therapy products also have highly variable Critical Quality Attributes, with fewer manufactured lots available for testing, so customized biostatistical support will be needed for statistical design and analysis for the final validated assay. Beyond the logistics of the validation itself, long term program management is critical for assessing both scientific and commercial considerations as the assay progresses from development to validation. ACF Bioservices’ highly-controlled GMP facility allows us to maintain control over all necessary considerations while validating.
To learn more on the process of validating a potency assay, please request a download of Karen Doucette’s presentation from the 2018 Bioprocessing Summit by filling out the form below.
Absorption Systems’ Boston-based laboratory was recently acquired as part of our overall strategy to even further expand our capabilities for large molecule therapeutics and in the cell and gene therapy sector. This, along with increased event activity further leaves a growing footprint in the Boston area. Following The Bioprocessing Summit, ACF Bioservices’ Potency Assay Experts will be attending Boston Biotech Week at the Bioprocessing & Commercialization event.
To schedule a meeting in Boston with one of our leading Cell & Gene Therapy Potency Assay Experts, please contact us at firstname.lastname@example.org or visit our website at acfbioservices.com.
Please complete the form below to request a download of ACF’s 2018 Bioprocessing Summit presentation on validating potency assays: