Process Development

Jul 19, 2018
By BioPharm International Editors
The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
Jul 12, 2018
By BioPharm International Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 01, 2018
BioPharm International
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
Jul 01, 2018
BioPharm International
Increasing demand for biologics is driving the need for innovation in bioprocessing.
Jun 07, 2018
By BioPharm International Editors
The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.
Jun 01, 2018
BioPharm International
Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
Jun 01, 2018
BioPharm International
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
May 31, 2018
By BioPharm International Editors
Ingenza, in partnership with the University of Dundee and Drochaid Research Services, will work on a project to recycle CO2 emissions from bioprocessing plants to serve as feedstock and energy inputs.
May 30, 2018
By BioPharm International Editors
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.
May 07, 2018
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
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