BriaCell Selects FUJIFILM Biotechnologies California for Bria-IMT Phase 3 and Commercial Manufacturing
- BriaCell Therapeutics has contracted FUJIFILM Biotechnologies California for CDMO services supporting Phase 3 clinical development and potential commercial supply of Bria-IMT, an off-the-shelf allogeneic cell therapy.
- Bria-IMT is in a pivotal Phase 3 trial (NCT06072612) for advanced metastatic breast cancer in combination with an immune checkpoint inhibitor.
Operational Impact
FUJIFILM Biotechnologies California adds cell therapy manufacturing capacity for a pivotal Phase 3 program with potential commercial scale-up, expanding its allogeneic cell therapy CDMO footprint.
Source: PharmaSource RSS
OXB Secures AAV Manufacturing Contract with Plowshare Therapies
- OXB will provide process development and AAV GMP manufacturing services to Plowshare Therapies for rare genetic disease gene therapies.
- Manufacturing will be conducted at OXB's FDA-approved viral vector facility in Durham, North Carolina, with potential for scale-up as Plowshare's pipeline advances.
Operational Impact
OXB's Durham viral vector facility adds committed AAV GMP capacity for rare disease programs, with contractual optionality for later-stage manufacturing as Plowshare advances its pipeline.
Source: Contract Pharma Breaking News RSS
Merck Opens €25M BioReliance Testing Facility in Darmstadt, Germany
- Merck inaugurated a 2,000-square-meter BioReliance testing facility in Darmstadt offering GMP-compliant drug substance, drug product release, and stability testing for biologics and cell therapies.
- The €25 million investment expands European in-region testing capacity and positions the site near major clinical trial hubs across Germany, France, Spain, Netherlands, Belgium, and Italy.
- Headcount is projected to grow significantly over coming years; the facility complements Merck's 2024 €290 million biosafety testing facility opened in Rockville, Maryland.
Operational Impact
The Darmstadt facility reduces testing turnaround for European biopharmaceutical clients by eliminating transatlantic sample shipment delays and regulatory complexity, strengthening Merck's competitive position in EMEA drug-product release and stability testing.
Source: Contract Pharma Breaking News RSS
Cytovance Biologics Adds Perfusion Capabilities to Upstream Process Development
- Cytovance Biologics has integrated perfusion technology into its upstream process development platform, complementing existing fed-batch manufacturing services.
- Perfusion enables continuous media supply and spent-media removal, supporting higher productivity and longer cell culture durations for monoclonal antibodies and recombinant proteins.
- The capability expands Cytovance's integrated CDMO offering alongside recent additions in cell line development and formulation services.
Operational Impact
Cytovance Biologics’ perfusion integration expands upstream flexibility for sponsors evaluating process strategies, reducing time-to-clinic for programs where fed-batch alone may not meet productivity or culture-duration requirements.
Source: PharmaSource RSS
References
- PharmaSource RSS — BriaCell Selects FUJIFILM Biotechnologies California for Bria-IMT Phase 3 and Commercial Manufacturin
- Contract Pharma Breaking News RSS — OXB Secures AAV Manufacturing Contract with Plowshare Therapies
- Contract Pharma Breaking News RSS — Merck Opens €25M BioReliance Testing Facility in Darmstadt, Germany
- PharmaSource RSS — Cytovance Biologics Adds Perfusion Capabilities to Upstream Process Development