Drug Target Review

SEPTEMBER 10, 2024

However, information would be required on whether the nominated formulation would be sufficiently stable to support the rapid formulation approach and subsequent comparison to the clinical supply. Therefore, there would be almost no appetite for trying to justify a change in formulation between Tox and clinical supplies.

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Drug Development Clinical Supply Production FDA 64

The Premier Consulting Blog

OCTOBER 26, 2022

Most of the available information at this point has been developed at the bench and pilot scale, and good manufacturing practice (GMP) is not introduced until the production of early clinical supplies.

Production 40

Production Assay Development Clinical Supply Clinical Development 40

The Pharma Data

NOVEMBER 22, 2020

Molecular Partners is also collaborating with AGC Biologics, Baccinex, and Ivers-Lee Clinical Supply Management (IL-CSM) to support development of its anti-COVID-19 program, and has reached an agreement with the Swiss Government regarding rights to purchase up to 3.2 million doses of MP0420, if it is approved in Switzerland.

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

OCTOBER 27, 2020

During the clinical development stage, Molecular Partners will provide clinical supply. The companies will work together to scale-up manufacturing capacity, in collaboration with Sandoz, the generics and biosimilar Novartis division, to provide worldwide supply. About Molecular Partners AG.

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Therapies Virus Treatment Clinical Trials 40