The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie's Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche's Herceptin. / read more /
The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled. / read more /
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The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger. / read more /
The agency has approved Mylan's Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen's Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment. / read more /
GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain. / read more /
The new kit is expected to detect a broad spectrum of pyrogens while offering high reproducibility and sensitivity as well as eliminating the need for live animal testing. / read more /
The approach presented in this study uses process capability index results to establish sampling strategies for use with new product cleaning and to efficiently reduce the risk of insufficient cleaning. / read more /
Naturally occurring and engineered albumins are being explored as a tool to enhance the stability of drugs, including biologics, and extend shelf-life. / read more /
Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing? / read more /
Shimadzu's i-Series Plus expands the product line and improves performance and user-friendliness. With i-Series Plus, pretreatment operations have been automated, such as the processes to dilute samples and add reagents.
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This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
