Thursday, April 14, 2022 Daily Archives

Aseptic closed small-volume processing: Today’s options

Small-volume biopharmaceutical processes continue to grow as more biopharmaceutical, cell therapy and gene therapy companies develop products. A 2021 Association for Regenerative Medicine (ARM) report states that there are 1,085 cell, gene and tissue-based therapy developers worldwide. These companies are engaged in many small-volume (<10L) processes including early-stage drug development and autologous therapies. The increase in small-volume processes coincides with the ongoing need to create fast, reliable aseptic closed systems. Historically, few convenient options have existed to facilitate sterile processing.…

Advanced therapy CDMO roundup: Deals for WuXi, Resilience, Fujifilm

Resilience will make gene therapies for Opus; WuXi Advanced Therapies will make CAR-Ts for Chimeric; and Fujifilm will make RNA oncology candidates for Chimeron. First up in our roundup of advanced therapy contract manufacturing deals this week is Opus Genetics, which has struck a deal with (National) Resilience to support its pipeline of adeno-associated viral (AAV) vector-based gene therapies for inherited retinal diseases. The contract development and manufacturing organization (CDMO) will provide process and analytical development, quality control testing, and…