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Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.
There is no such thing as a perfect linker.
A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.
Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.
USP offers strategies to minimize residual impurities in downstream processing.
December 05, 2023
AstraZeneca will utilize Absci’s AI antibody drug creation platform to create an AI-designed antibody.
December 02, 2023
Biologics have specific quality considerations that make fast tracking these drugs more difficult.
Preparing for variability and flexible processing are necessary for success.
December 01, 2023
Digital transformation allows for smarter and connected biomanufacturing operations.
Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
Novo Nordisk will invest more than DKK 16 billion (US$2.3 billion) to expand its production facilities in Chartres, France.
Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.
Final product inspection results should be included as part of the batch release documentation, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
November 30, 2023
Exagamglogene autotemcel seen as synechdoche.
November 29, 2023
TAU Systems plans to establish TAU Labs, a new next-generation, laser-driven plasma accelerator laboratory, in Carlsbad, Calif.
Under this multi-year collaboration, Genentech and NVIDIA will use AI to optimize and accelerate each company’s platforms to discover and develop innovative therapeutics.
November 27, 2023
Chris Spivey, editorial director for Pharmaceutical Technology, discusses messenger RNA (mRNA) advances with Guillaume Roelandts, Head of Products and Marketing, Quantoom Biosciences, at the 11th International mRNA Health Conference in Berlin, Germany.