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

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. April 4, 2022. References “Approved Cellular and Gene Therapy Products.” Food and Drug Administration. link] “UPDATED: bluebird bio’s $2.8

Therapies 130

Therapies Drug Development Clinical Trials Cell Based Assays 130