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Manufacturing

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USP Sparks Debate Over Rapid Sterility Testing For Cell And Gene Therapies

For short-lived cell and gene therapies that must be given to patients before traditional sterility testing results can be obtained, the question is whether less sensitive rapid tests that can be completed in advance might be a better choice. Should manufacturers demonstrate a lack of viable microorganisms, or is it OK merely to show there aren’t enough of them to produce an “infectious dose”?

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Latest From Manufacturing

Firms Should Characterize Their Cell And Gene Therapies Early, FDA Says

US FDA official advises that to avoid the “brick wall” of BLA rejection, manufacturers should characterize their cell and gene therapy products and develop potency assays as early as possible.

United States Manufacturing

FDA Launches Protocol For Inspections Of Sterile Drug Manufacturing Facilities

US FDA expects the New Inspection Protocol Project (NIPP) it launched Nov. 9 to increase the consistency of its sterile manufacturing inspections – and the ability of those inspections to catch quality problems before they could lead to drug shortages.

Quality Compliance

Good News For Australian Sponsors Sourcing APIs From Canada

Australian and Canadian drug regulators have extended their mutual recognition agreement on good manufacturing practice inspection and certification to include active pharmaceutical ingredients.

Australia Canada

Mexico and Argentina To Cut Burden for Pharma By Swapping GMP Reports

Medicines regulators in Mexico and Argentina have agreed to exchange good manufacturing practices inspection certificates.

South America Argentina

Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies

Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.

Drug Review Profile Biosimilars

Firms Face New Australian Rules On Autologous HCTs From Mid-2019

Companies in Australia are being urged to make sure their autologous human cell and tissue products will meet new regulatory requirements starting in July next year.
Australia Regulation
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