The latest issue of BioProcess International focuses on downstream processing, featuring articles on host-cell DNA, product specifications, depth filter turbidities, and buffers. It also features Part 2 of the BioPhorum Operations Group article on technology roadmapping.
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Cell, Gene, and Tissue Therapy
Cell therapy bioprocessing has advanced from limited efforts in specialized laboratories and academic institutions to becoming part of the mainstream biologics industry, with hundreds of companies involved and 20 product approvals in the United States (and more elsewhere). This featured report takes a snapshot of the processing issues of today — manufacturing platforms, purification of viral vectors for gene therapy, three-dimensional bioprinting — and looks toward the future of this biologics market segment.
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The BioPhorum Operation Group’s (BPOG’s) Container Closure Integrity Testing (CCIT) workstream would like to congratulate the United States Pharmacopeia’s committee for its latest revision to USP chapter <1207> Package Integrity Evaluation: Sterile Products. Generally, we believe it provides a comprehensive overview of the available methods for container–closure testing and outlines many important elements for consideration in establishing a successful CCIT strategy. We first responded to the USP <1207> draft when it was released for comment in 2014. And from our…