mAbxience and Sandoz are targeting a $5.7 billion market with a proposed emicizumab biosimilar for hemophilia A.
|Articles|May 17, 2018
Catalent Adds Capacity at Kansas City Clinical Supplies Facility
Author(s)BioPharm International Editors
The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.
Advertisement
Catalent Pharma Solutions announced on May 17, 2018 the completion of the second phase of a $5.5-million expansion program at its Kansas City, MO facility, which increased the controlled-substance and controlled-temperature storage capabilities for its clinical supply business.
The expansion included a Drug Enforcement Administration Schedule I and II controlled substance vault; 3600-sq.-ft. of additional storage; controlled-temperature storage capacity with 450 new pallet locations and 500 new high-density storage locations; a sampling room; and an emergency generator.
The 450,000-sq.-ft. facility provides development and analytical support through to packaging and distribution, the company reported in a press statement. Previously, the company announced expansions at clinical supply facilities in
Source:
Advertisement
Related to this article
Athenecia Faggins of Minaris Advanced Therapies discusses raw material qualification, supplier management, testing, and risk control for advanced therapy manufacturing.
Four cell therapy developers have pulled back from ex vivo manufacturing in the past month — ArsenalBio, TScan Therapeutics, and Cellectis all pivoted to in vivo approaches, while Bristol Myers Squibb terminated its manufacturing partnership with automation specialist Cellares after determining its platform couldn't meet requirements for commercial Breyanzi production, triggering layoffs.
Phio's PH-762 posted a 70% response rate in skin cancer, supporting its FDA briefing package for a planned phase 2b trial.
Samsung Biologics signed a $262 million contract manufacturing agreement with an undisclosed European pharmaceutical company, extending production commitments through 2033 and lifting the CDMO's cumulative contract value past $21.9 billion.
With 15 patients now dosed in its pivotal EMERALD trial, Resolution will build on the 70% 4-year transplant-free survival seen with RTX001 in earlier data.
Del-desiran missed its primary endpoint in a phase 3 DM1 trial, though secondary measures showed signs of clinical activity.
Fayuvi scored 23.5 points higher than untreated peers on cognitive testing, backing the first-ever approval for a Sanfilippo syndrome A gene therapy.
Advertisement
Advertisement