The Pharma Data

MAY 26, 2023

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.,

Clinical Supply 52

Clinical Supply Therapies Clinical Trials Packaging 52

The Pharma Data

JUNE 7, 2023

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.

Clinical Supply 40

Clinical Supply International Packaging Therapies 40

The Pharma Data

DECEMBER 14, 2020

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.

Clinical Development 52

Clinical Development Clinical Supply Pharmacokinetics Packaging 52

LifeSciVC

AUGUST 21, 2024

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.

Clinical Trials 62

Clinical Trials Trials Disease Clinical Supply 62

Drug Target Review

SEPTEMBER 10, 2024

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.

Clinical Supply 64

Clinical Supply Drug Development Production Animal Testing 64

Drug Discovery World

MARCH 13, 2023

Drug discovery researchers usually partner with a CDMO to provide support through the development, manufacturing, and clinical supply required to bring a drug to market. Manufacturers have a consistent cell line to start the manufacturing process and reliable platform equipment that varies only based on the scale of their operations.

Therapies 130

Therapies Drug Development Clinical Trials Cell Based Assays 130