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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

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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How to Optimize Drug Development by Combining FSO and FSP Models

PPD

Approaches to outsourcing clinical trials have changed significantly in recent years. It’s important to understand the differences between FSO and FSP solution models for outsourcing clinical trials and how best to combine approaches for optimization. Overseen by an insourced project manager.

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A Biotech Midsummer’s Madness

LifeSciVC

Clinical Trials Are your clinical trials on track? Companies fortunate enough to have reached the clinical stage are asking this question. What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Or maybe you are nearing the clinic.

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

The Pharma Data

VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease. Pfizer is collaborating with Vivet on the clinical supply of VTX-801 for the Phase 1/2 clinical trial.

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

The Pharma Data

The launch of the expanded offering will coincide with Catalent exhibiting at the BIO International Convention (booth 785), which takes place at the Boston Convention & Exhibition Center, from June 5-8, 2023. At the BIO International Convention, Carey Connolly, Ph.D., at the BioProcess International Theater.

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Tech Transfer Tools: The Requirements and Uses of Manufacturing Process Descriptions

The Premier Consulting Blog

technical operations, product development or process development) to an internal or external receiving unit (e.g., clinical manufacturing, commercial manufacturing, or contract manufacturing organization). Development of the manufacturing process description The development of the MPD is an iterative process.