Iovance Biotherapeutics has made progress in developing potency assays for lifileucel, a tumor-infiltrating lymphocyte therapy for advanced melanoma patients. Developing potency assays for lifileucel ...

Gregory Russotti is the Chief Technology and Manufacturing Officer at Century Therapeutics, a company developing iPSC-derived, allogeneic immune cell therapy products for hematology/oncology ...

Since biological therapeutics are derived from living organisms, their manufacture and validation presents difficulties not encountered during traditional small molecule drug development. Despite the ...

MarinBio publishes validated GMP/GLP cell-based potency assay for AAV-delivered anti-CD3-anti-CD19 diabody (GP101) in Journal of Immunological Methods. This publication is a milestone for the cell & ...

Several pharmaceutical industry groups and companies have criticized the US Food and Drug Administration’s (FDA) recent guidance on potency assurance strategies for cell and gene therapies (CGTs) ...

Thepatent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral ...

Officials from the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) within the Center for Biologics Evaluation and Research (CBER) urged developers of gene therapies to ...

Joshua Hare, MD, FACC, FAHA, Co-Founder, Chief Science Officer and Executive Chairman, Longeveron Thepatent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived ...