2022-23 Academic Calendar (PDF)
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Please join us for our PhD Student, Mandar Narayan Makwana’s – Graduate Student Literature Seminar on – “Advancements in bioprocess development: Application of machine learning and process analytical technology (PAT) for Generation 4.0 bio-processes”
There have been significant advancements in process development across the manufacturing spectrum. Processes have evolved from manual processing (gen 1.0) to the use of automation (gen 2.0) to achieving six-sigma manufacturing capability (gen 3.0). The FDA has developed guidance documents on Quality by Design (QbD) and implementation of Process Analytical Technologies (PAT) which have paved the path to gen 3.0 processes. Other industries have started to develop platforms for a gen 4.0 process which involves artificial intelligence (AI) and machine learning (ML) capabilities. Advancements in analytical tools and computational methods have led to a coupling of gen 3.0 and gen 4.0 processes. The aim is to utilize real-time datasets and ML algorithms to predict the critical quality attributes of the final product. It is predicted that with the implementation of these technologies lot-to-lot variability will be reduced thereby preventing manufacturing failures and decreasing development timelines for new products. This literature review focuses on challenges that the bio-manufacturing space encounters to reach generation 4.0 bioprocesses, and strategies either implemented or in development that address these challenges.
Date: Friday, May 27, 2022
Time: 12:00 – 1:00 p.m.
Location: Via Zoom – Zoom link will be sent with Outlook Invite to KGI Community
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