Animal Testing, Production and Protein Expression

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Animal Testing

Production

Protein Expression

Rapid delivery of toxicological material

Drug Target Review

SEPTEMBER 10, 2024

For example, tox material from a pool of clones will contain a potentially broader profile of product quality attributes (eg glycan profile, high molecular weight species, etc) in addition to potentially slightly higher relative amounts of process impurities which can resemble the worst-case scenario during the toxicology testing.

Drug Development

Drug Development Clinical Supply Production FDA

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

Therapies

Therapies FDA Production Disease

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Drug Discovery Digest

Rapid delivery of toxicological material

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

Webinars

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