BioPharma Reporter
AUGUST 14, 2023
Teknova, a producer of life science reagents, has opened a new GMP-certified production facility which it claims will enable bioprocessing and gene therapy companies to get into the clinic faster.
Pharmaceutical Technology
FEBRUARY 3, 2023
“For each production process, you have to generate the plasmids in huge quantities with GMP quality and then do a transient transfection, meaning you mix them with a transfection reagent and add that to the cells in a very controlled way,” explains Faust. For example, researchers have developed a two-plasmid cotransfection system.
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BioPharma Reporter
FEBRUARY 22, 2024
MIP Discovery, a developer of non-biological affinity reagents designed to accelerate the production of cell and gene therapies, has closed a Â7 million Series A financing round, led by Mercia Ventures.
pharmaphorum
SEPTEMBER 29, 2022
The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.
FDA Law Blog
AUGUST 3, 2022
Thirty years ago today, FDA announced that it had the authority to regulate you. These two sentences turned out to be the opening salvo in a thirty-year battle – and counting – over how LDTs should be regulated. That growth has, unsurprisingly, led to different views about regulation of LDTs. By Jeffrey N. Gibbs & Allyson B.
FDA Law Blog
APRIL 19, 2021
FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.
FDA Law Blog
NOVEMBER 1, 2023
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
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