In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.
A former FDA Biologics License Application reviewer and inspector focusing on microbiology, shares expert tips on how to best approach a bioburden problem when an FDA inspection is imminent.
In spite of the FDA’s announcement to postpone enforcement until November 2018, all other requirements of the DSCSA remain the same
There is a lot of interest around continuous biomanufacturing, but could a hybrid of batch and continuous unit operations be the best solution for your process train?
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.
Inaccurate demand forecasts can have significant implications for companies developing biologics. And, it is increasingly difficult to locate capacity to respond to demand changes.
As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.
Many biologics companies will partner with a contract development and manufacturing organization that can provide the required expertise and resources as well as flexibility of operations.
Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.
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