Search results for " manufacturing"
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Innovative Therapies Require Modern Manufacturing Systems
In developing and bringing to market important new therapies, Jenkins noted, it’s “often manufacturing and inspections that are the rate-limiting steps” for expedited approvals, not clinical developme…
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Biosimilars to Drive Modern Manufacturing Approaches
And new guidance documents are scheduled on standards for achieving product interchangeability, statistical analytical approaches for documenting product similarity, and managing post-approval manufac…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
It’s “not simple” to bring a clinical production process to commercial scale, he says, voicing fears that important manufacturing issues could hinder efforts to advance new discoveries able to transfo…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
A June 2017 workshop on “Navigating the Manufacturing Process and Assuring the Quality of Regenerative Medicine Therapies” discussed challenges in evaluating the quality and purity of unique cell popu…
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Transformative Medicines Challenge FDA and Manufacturers
…or tackling quality risk management, setting specifications, and assuring compliance with chemistry, manufacturing, and control (CMC) standards for experimental treatments. Presentations covered the …
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The New World of Biopharmaceutical Manufacturing
By Jennifer Markarian
Without question, biopharmaceutical manufacturing has changed dramatically since 1977, when it was in its infancy. The ball really began roll…
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Modern Manufacturing Key to More Effective Vaccines
And the imperative to combat infectious disease outbreaks and deadly conditions such as malaria and tuberculosis emphasizes the need to modernize and streamline vaccine testing and manufacturing.
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Scalable Viral Vector Manufacturing
As cost pressure in the biopharma and vaccine industry increase globally, the choice of manufacturing technology is becoming increasingly important. The manufacturing processes and technologies are cr…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
23, 2015, FDA released draft guidance on the Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base. The guidance discusses the inclusion of a new FDA progr…
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Biopharma Manufacturers Respond to Ebola Crisis
FDA also is working with WHO’s International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate testing of experimental treatments and to provide more flexibility for meeting manufact…