FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
Historically, pharmaceutical products have been produced in a traditional ‘batch’ system, in which every operation is executed separately using a defined quantity of materials. In batch manufacturing ...
The pharmaceutical industry has been slow to adopt a business practice that is faster, safer, and more efficient than its current way of operating; that the FDA has been encouraging the industry to ...
Eli Lilly’s breast cancer med Verzenio may look like your standard drug tablet—ovular, off-white, emblazoned with the dosage on the front and Lilly’s logo on the reverse—but behind that modest façade ...
In March 2023, the FDA issued a final guidance, titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products” that describes scientific and regulatory considerations for the development, ...
Drug firms looking to ramp-up production with continuous processes must think beyond the reactor and ensure the technologies used downstream can also manage sustained 24/7 manufacturing. Continuous ...
Continued process verification (CPV) is the third stage of the product lifecycle of any medicine either within the small or large molecule arena. The CPV is the subsequent step to process design ...
Continuous manufacturing makes monoclonal antibody production faster, cheaper, and greener, say researchers, who predict that industry adoption of the approach will accelerate in response to ...
Key market opportunities in the biologics contract manufacturing sector include robust growth driven by rising demand due to ...
A 3-year research program, funded by the FDA, aims to design the first continuous mRNA-manufacturing platform. Faculty at the Massachusetts Institute of Technology (MIT; MA, USA) will be leading a ...
The manufacture of medicines must draw on expertise from a wide range of disciplines, from the initial investigation and design of a new drug or therapeutic to wide-scale production and distribution, ...
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