Remove Clinical Supply Remove International Remove Therapies
article thumbnail

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.,

article thumbnail

How to Optimize Drug Development by Combining FSO and FSP Models

PPD

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Most often done using the vendor’s systems and standard operating procedures (SOP).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

article thumbnail

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
article thumbnail

A Biotech Midsummer’s Madness

LifeSciVC

As the CEO of Lifordi Immunotherapeutics, an ADC company developing treatments for autoimmune and inflammatory diseases, there are three components to manufacture, multiple international CDMOs to manage, and complex supply chains to navigate. I can tell you that CDMO summer shutdowns are a real thing.