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Collaboration will apply Cellares' Cell Shuttle and Cell Q platforms to TSC-101 as a potentially scalable and cost-efficient path to commercialization.
By: Kristin Brooks
Will perform process development and technical transfer services in support of anticipated commercial manufacturing upon regulatory approval.
Successfully tech-transferred and manufactured first commercial-scale GMP batches of Renaissance Pharma’s lead candidate, Daretabart.
Aims to boost clinical supply and commercialization readiness for Ratio’s lead radiopharmaceutical therapy.
By: Charlie Sternberg
OPUVIZ becomes Samsung Bioepis’ fifth directly commercialized biosimilar product.
The partnership includes licensing, co-development, and co-commercialization opportunities across a diverse portfolio of antibody-drug conjugates.
Besremi is a treatment for polycythemia vera for which PharmaEssentia is seeking a label expansion to include essential thrombocythemia.
By: Patrick Lavery
Accord BioPharma will be responsible for commercializing IMMGOLIS and IMMGOLIS INTRI in the U.S.
Both parties will leverage Fosun Pharma's capabilities in R&D, manufacturing, regulatory affairs and commercialization to accelerate the global launch of AR1001.
Addresses manufacturing challenges related to scalability, cost of goods and process consistency as gene therapy programs move toward commercialization.
McCullough Wood offers nearly three decades of experience across API, CDMO, and drug product services.
Will support a sustainable path from clinical development to commercial access for therapies serving the smallest patient populations.
As trade policy, regulatory scrutiny, and capital discipline reshape biologics development, sponsors are rethinking where and how commercial manufacturing is secured. Bora Biologics’ recent U.S. expansion and validated 2,000L scale-up reflect a broader shift toward demand-aligned, inspection-ready commercial capacity in the markets where products will ultimately be supplied.
Released By Bora Biologics
There are many reasons for a pharmaceutical company to perform a tech transfer to a contract manufacturing organization (CMO).
Released By AbbVie Contract Manufacturing
Appoints Brian Walls as Vice President, Market Access and Darren M. Johnson as Vice President, Commercial Operations.
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