The Pharma Data

MAY 26, 2023

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. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year.

Clinical Supply 52

Clinical Supply Therapies Clinical Trials Packaging 52

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 Clinical Trials 52

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.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

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 77

Clinical Trials Trials Disease Treatment 77