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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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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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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

Over the last two years, AlgoTherapeutix took ATX01 from exploratory prototype to final formulation, established its pharmacological profile, conducted a full pre-clinical toxicology package, and scaled-up manufacturing to enable clinical supply production.

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Rapid delivery of toxicological material

Drug Target Review

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package. Therefore, there would be almost no appetite for trying to justify a change in formulation between Tox and clinical supplies.

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A Biotech Midsummer’s Madness

LifeSciVC

Keeping ahead of schedule will help to maintain manufacturing efficiencies, ensure adequate supply and product quality, and meet development timelines. I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us.