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01:20:29
Particulates in Cell & Gene Therapy Products: A Survey and a SolutionPresented by the ISCT Process Development and Manufacturing Committee
The Process Development and Manufacturing Committee sent out a survey to Cell Therapy developers and service providers on commonly used regulatory guidance documents on particulates across various cell & gene therapy (CGT) product based chemistry and manufacturing controls (CMC). From the 97 respondents, lead products covered the discovery to Phase 3 clinical stage. There was incomplete or spotty awareness of the 14 documents on particulates from the European Pharmacopeia, USP and ISO standards. Administration routes covered all methods, IV, IT, IM, IO, IM and Subcutaneous. Responders were concerned about a wide variety of particulates in their process during manufacturing and packaging. They were aware of visual, microscopy, laser scattering, flow cytometry and RAMAN spectroscopy methods of particle measurements. Following this survey, the latest science on particulate detection will be presented. Panel members from the PDM committee will then discuss and field questions on the implications of these findings.
Dr. Steve Oh, Ph.D.
Independent Cell Therapy Leader
Singapore
Dr. Nisha Durand, Ph.D.
Assistant professor of Regenerative Medicine & Manager of Process Development
Human Cellular Therapy Laboratory - Center for Regenerative Biotherapeutics (CRB) Mayo Clinic
USA
Survey Readout and Results Discussion
Nisha Durand, Ph.D. is an Assistant professor of Regenerative Medicine & Manager of Process Development at the Human Cellular Therapy Laboratory - Center for Regenerative Biotherapeutics (CRB) Mayo Clinic Florida. Dr. Durand is responsible for developing and evaluating novel biotherapeutics under cGMP-compliant manufacturing operations. Dr. Durand works closely with clinician investigators at the CRB to manufacture and deliver novel cell therapies to various patient populations.
Nisha received her Ph.D. in Biochemistry and Molecular Biology from Mayo Clinic Graduate School of Biomedical Sciences in the spring of 2017. For her doctoral thesis, she examined the role of protein and lipid kinases in focal adhesion signaling and cell migration in the context of cancer metastasis. Dr. Durand graduated summa cum laude from Chadron State College with a BSc in Human Biology in 2012.
Dr. Durand is an active member of the International Society of Cell & Gene Therapy (ISCT) and currently serves on ISCT’s Early-Stage Professional Committee as Co-chair of the Mentoring Working Group and is also involved with the Process Development & Manufacturing and Mesenchymal Stromal Cell Committees.
Outside of the Regenerative Medicine space, Dr. Durand is passionate about increasing diversity in STEM and currently serves as a Department Diversity Leader and is a member of CRB’s Equity, Diversity, and Inclusion Advisory Committee.
Dr. Paul Dyer, Ph.D.
Field Application scientist
Halo Labs
United states
Total particle analysis in
complex cell therapies: differentiating the extrinsic, intrinsic, and inherent particles with Aura.
Paul has over 25 years of experience in the Biotech, Academic and Healthcare industries. In his early career, Paul was instrumental in developing and running the bone marrow and stem cell processing service at Barts Health NHS Trust in London. Following on from this, he moved into academia, developing an interest in drug delivery strategies for the manipulation of cells for therapeutic use, obtaining his Ph.D. in Cell Biology and Drug Delivery Strategies from the University of Greenwich. Following this period in academic research, Paul joined Halo Labs as an application scientist covering UK and Europe. Building upon his extensive background in medical science, he has been focusing on the development of new applications of particle analysis within the area of biologics, in particular cell therapies, resulting in the release of a new product, the Aura CL® and the Aura+®.