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The autologous nature of its gene-edited stem cell candidate CTX001 means scaling manufacturing from clinical to commercial will be relatively easy, says CRISPR Therapeutics. Codeveloped with Vertex Pharmaceuticals, CRISPR Therapeutics’ CTX001 is an autologous CRISPR/Cas9 gene-edited hematopoietic stem cell therapy targeting patients suffering from β-thalassemia and sickle cell disease. Production of the candidate involves collecting a patient’s own blood stem cells via mobilization and apheresis and editing them with CRISPR/Cas9 to increase fetal hemoglobin (HbF) expression. When the edited cells…
CDMO Catalent has completed an $85 million expansion at its Madison drug substance facility and has started work on customer programs. The contract development manufacturing organization (CDMO) Catalent has added two mammalian cell culture suites at its Madison facility, meaning the site has five suites in total and has more than doubled its overall capacity. The two additional suites each boast a 2 x 2,000 L single-use bioreactor system that can process batches of 2,000 L or 4,000 L for…
The US FDA’s CDER  has named Patrizia Cavazzoni as its permanent director. Meanwhile, there are high level changes at Rentschler Biopharma, Bone Therapeutics, and Imvax. Sit back, relax, and enjoy BioProcess Insider’s Ins & Outs. The appointment comes after Cavazzoni has served as acting director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) for the past year after Janet Woodcock stepped away from the role to assist Operation Warp Speed (OWS) in response to…
Lonza has expanded its collaboration with Junshi Biosciences to develop and manufacture an antibody candidate at its recently opened, Guangzhou facility. Swiss contract development manufacturing organization (CDMO) Lonza has extended its partnership with Chinese firm Junshi Biosciences to advance and manufacture biologics. The agreement also includes the production of an antibody candidate that will be manufactured at Lonza’s site in Guangzhou, China. Under the agreement, Lonza will provide support to develop and manufacture current and future antibody-based products in Junshi…