Meet the Forge Experts

Key Focus Areas: At-Line PAT for mammalian cell culture processes

Thaddaeus Webster is an R&D Supervisor at Lonza Biologics. He leads a team focusing on At-Line PAT for mammalian cell culture processes. In his current role, Thaddaeus is responsible for developing and implementing novel technologies to support process development as well as commercial operations. He holds a Ph.D. in Chemical Engineering from Northeastern University.

Key Focus Areas: Process analytics, protein analytics

James is a leader in analytical and process sciences with fifteen years’ experience in biopharmaceutical analytical development and R&D. He is passionate about building teams and enabling them to solve industry problems. His technical focus is on Quality by Design for analytical methods, analytical bioseparations and mass spectrometry.

Key Focus Areas: Bioburden, mycoplasma, Virus testing; Quality control

Subject Matter Expert (Principle Scientist) in the QC Microbiology Team

Tracy worked for Lonza QC since 2004. She focuses mainly in the safety aspect of product batch release, specialising in Bioburden, Mycoplasma, Virus testing and also microbial identification.

As well as overseeing the testing required for release, she is also involved in the planning and reporting of method evaluation/ verification against the regulatory guidelines for biological licence applications.

Key Focus Areas: Protein characterization, microbial genotyping, at-line mammalian manufacturing bioprocesses and analytics.

Jessica Hodgkins is a Research Scientist in the Lonza Research and Development PAT & Automation Center of Excellence. She earned her B.S. in Biomedical Science at the University of New Hampshire where she aided in research on protein characterization and microbial genotypic discovery. Currently she focuses on at-line solutions for mammalian manufacturing bioproceses and analytics.

Key Focus areas: Upstream biomanufacturing process development including cell line engineering and selection, media development and selection, scale-up and scale-down.

Dr. Jaques took a BSc in Biotechnology at Imperial College, a MSc in Biochemical Engineering at University College London and a PhD in Biochemical Engineering at University College London. He have worked at Lonza for more than 18 years covering most areas of upstream process development including cell line engineering, cell line selection, media development, media optimisation, scale-up and scale down. He is currently a director in Lonza’s BioR&D department in the process science and technology group.

His interest in the rapid detection of microbial contaminants stems from a desire to integrate all process analytics into the process. Being able to achieve this is an important step towards real time release of products. He believes that if they can’t achieve rapid integrated testing for microbial contaminant detection then integrating the rest of the analytics is of limited benefit.

Key Focus Areas: Microbiology, QC
Since May 2023 @ QC Microbiology Lonza DPS Stein (aseptic fill/finish site). He is responsible for building up a new microbiology lab including rapid and automated methods. Further, he defines and implements microbiological concepts. Previously, Dr. Thölken received his PhD in pharmaceutical Chemistry Universität Freiburg. He worked up to 2015 in MS&T Microbiology Novartis Stein (aseptic fill/finish site). Here, he was a subject matter expert with with troubleshooting QC issues (method failures, validations, exceedances, etc). He also assisted with implementation of rapid QC methods (Growth direct system from RMB).

Key Focus Areas: Quality Control, monitoring solutions, microbiology
Eka has been with Lonza for 2 years focusing in Quality Control Microbiology as a Senior Lab Assistant and presently a Senior Quality Assurance Specialist in Environmental Monitoring. Previously she achieved her Master of Science in Biology at Freie Universität Berlin.

Key Focus Areas: Compendial methods; Bioburden testing; Contamination control, Microbiology

Sallyann is the Microbial Contamination Control Lead for the Lonza Slough site, which is a role within the Quality Control Microbiology team. She has worked at Lonza Slough for 20 years. As part of her current role she is required to complete proactive and reactive actions in relation to microbial contamination; such as assessing processes within the manufacturing facility and implement changes that reduce the likelihood of microbial contamination event occurring and helping investigate microbial contamination events. Previously she has worked within the Microbiology laboratory which included completing bioburden testing on product samples using the standard compendial method.