6.1.1 A key milestone in the establishment of good safety testing was the development of rapid microbial testing (RMT). With traditional biologics, microbial testing for contaminating bacteria could take up to a month.[144] When the product must be released within a matter of days, traditional microbial testing methods became obsolete. Microbial testing is a critical release criterium because cell therapy products cannot be terminally sterilized.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
6.2.1 Potency assays, however, have been a bigger challenge for the industry, and inadequate potency assays have led to clinical holds. At a 2022 meeting between regulators and developers, Dr. Peter Marks, former director of CBER, remarked, “I think there’s pretty uniform agreement that one of the key things that has delayed a fair number of approvals over the course of time has been issues related to potency.” An early example of this challenge is demonstrated by the experience of Iovance Biotherapeutics, which encountered a clinical hold specifically due to an inadequate potency assay.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.
6.3.1 Although CAR-T cells are frozen and should be stable during cold storage and shipment, the high variation in donor starting material and therefore final drug product makes demonstrating stability of these and other autologous therapies difficult. In 2020, Bristol Myers Squibb (BMS) presented data that donor variance attributed 82% of the total variance between lots.[154] This, however, is only one of the reasons that stability testing of autologous therapies is particularly challenging.
Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.Nice Insight provides customers with the latest trends in the market, hard-to-find pricing, and analysis of important scientific innovation and challenges. Our research reports help innovators understand the price they'll pay for a contractor and what challenges they should anticipate, and allow CDMOs to evaluate their position in the market.