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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. With sites in the U.S.,

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Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Conversations in Drug Development Trends

By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Below, we discuss some of these challenges in cell therapy trials.

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VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. The FDA’s Fast Track program is designed to facilitate the development, and expedite the review of, novel potential therapies that are designed to treat serious conditions and fill unmet medical need. NYSE: PFE) today announced the U.S. About VTX-801.

Disease 52
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Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities

The Pharma Data

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch.

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Molecular Partners Announces Collaboration With Novartis to Develop Two DARPin(R) Therapies Designed for Potential Use Against COVID-19

The Pharma Data

MP0420 and MP0423 are potential medicines with a unique approach for both the prevention and treatment of COVID-19, with the possibility to manufacture at scale, easy administration and with the potential to bypass cold storage. During the clinical development stage, Molecular Partners will provide clinical supply.

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A Biotech Midsummer’s Madness

LifeSciVC

And importantly, breaks from treatment or treatment protocols can literally make or break trials. There is no room for a missed dose, a scheduled follow-up visit or opportunities to bring new clinical sites on board. can have a significant impact on manufacturing timelines and drug supply chains.

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MorphoSys To Present At the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.