In recent years, fed-batch biomanufacturing has begun giving way to continuous manufacturing processes, as developers face pressure to balance affordability with high manufacturing quality. Although ...
Continuous pharmaceutical manufacturing represents a significant shift from traditional batch processing, integrating continuous flow methods, advanced process analytical technology (PAT) and ...
Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...
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 ...
The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative was ...
HORSHAM, Pa. & PALO ALTO, Calif.--(BUSINESS WIRE)--Aegis Software, a global provider of Manufacturing Operations Management Software (MOM/MES), and Arch Systems®, the leading provider of data and ...
The CHIPS and Science Act will allow for new investments in manufacturing research. U.S. Rep. Abigail Spanberger of Virginia is calling for increased investments to strengthen continuous prescription ...
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, ...
The system converts conventional batch production of plant-based meat substrates into fully continuous and automated ...
TOKYO, June 5, 2019 /PRNewswire/ -- FUJIFILM Corporation (President: Kenji Sukeno), today announced an initial $10M USD investment to establish a full scale, fully integrated continuous processing ...
Fed-batch and batch bioprocessing still dominate monoclonal antibody (mAb) production, but that must change if mAbs are to become economically viable therapeutic options. Current production techniques ...
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