Mammalian cell cultures are widely used as the workhorse platform in the production of biological products such as antibodies or other therapeutic proteins. Deviations of critical process parameters (CPP) in upstream operations can directly lead to physicochemical and biological heterogeneities in the biological expression system and associated critical quality attributes (CQA) in therapeutic products. Hence, Process Analytical Technologies (PAT) represent an enabler to the Quality by Design (QbD) paradigm to generate adaptive processes that can maintain productivity and reduce product quality deviations through the implementation of process monitoring and control sensors.
In this webinar, you will receive:
Bio4C™ ProcessPad Product Manager
Hemant Garg is on a digital mission to help the biopharmaceutical industry grow and evolve in a data-driven world. Trained as a business analytics biotechnology engineer, he has 13 years of professional experience working across multiple roles within biopharma manufacturing. Hemant’s expertise in industry research, long-term forecasting, data analytics, and process modeling enables him to identify and capitalize on unmet market needs. As product manager analytics in integrated solution marketing, Hemant leads the strategy and launch of digital and analytics products for biopharmaceutical customers.
PAT Implementation & Support Engineer
Kevin Grollier graduated from the Lyon Pharmaceutical Industry Institute (IPIL), with an M.S. in pharmaceutical production specializing in biotechnology. This diploma was reinforced by training at the management school of Lyon. Within our company, he is a PAT Implementation and support engineer in charge of implementing Raman projects at customer sites, training ProCellics™ Raman Analyzer with Bio4C™ PAT Raman software users, and providing customers with technical support on hardware, software, and data analysis topics. Before joining our company, he worked at Merial (now BIAH) as a QA validation engineer where he had the opportunity to work on various items of the validation.