The Business Benefits of PAT in Continuous Drug Product Manufacturing


22nd September 2021 | 10:00am EST | Steve Hammond, Independent Consultant at Steve Hammond Consulting |BOOK FREE SEAT FOR THIS WEBINAR

It is well recognized that continuous processing requires continuous monitoring, at the “heart-beat” of the process to ensure product quality and patient safety.  However, the use of PAT in the optimization of equipment and the development of processes from which a product will be manufactured is also of significant value, and justifies the investment in PAT for continuous manufacturing. The data density and timeliness can deliver immediate feedback and exquisitely detailed information on the success of processing steps. The gathered information can aid in the establishment of an effective and robust processing regime for new or existing products.

This paper will discuss the use of information rich PAT technologies to understand equipment and process steps during development. Examples of equipment characteristics and the effect on the product will be examined.

An important area for PAT in continuous manufacturing is cleaning. The equipment trains to be effective must be capable of rapid change over. PAT’s designed for rapid assessment of surface cleanliness is important. Devices that allow rapid cleaning verification will be discussed.

 

Presented by Steve Hammond, Independent Consultant at Steve Hammond Consulting

Steve retired in 2018 after 39 years with Pfizer. He is now an independent consultant. Steve has an Honours Degree in Chemistry from the Royal Institute of Chemistry and a Masters Degree in Analytical Chemistry from the University of Kent, UK.  Steve held the title of “Chartered Chemist” in the UK. He joined Pfizer from Unilever’s Perfumes Division in 1979, to work as an Analytical Chemist in the Global Fermentation Development Group, where he developed a number of Process Analytical Technology (PAT) Applications for Pfizer’s Bioprocess Manufacturing Division.

Steve’s role evolved to the position of Senior Director of the Process Analytical Sciences Group (PASG), Pfizer Global Technology Services, based in the USA.  Steve held two leadership functions, PAT Development and Deployment and also  Material Sciences support, to the Pfizer network of Manufacturing plants. These responsibilities covered all of the major business divisions: BioPhama, Small Molecule Pharmaceuticals, Consumer Products, and Animal Health divisions. The last 10 years of Steve’s time at Pfizer had a heavy focus on the development of analytical and control systems for continuous manufacturing, both small molecule API and Drug Product.

After retirement, Steve has continued his interest in developing capabilities in small footprint portable manufacturing, Continuous Freeze Drying, and Continuous Sterile Liquid production. He has published and presented many papers on the application of PAT to pharmaceutical processing. He has also contributed to a book chapter on Chemical Imaging. Steve has been an industrial supervisor for 4 Ph.D. students.

Steve is a member of the Scientific Board of The International Forum for Process Analysis and Control, IFPAC. Steve is a Board Member of a not-for-profit company Med Aditus, which is attempting to build a local small foot-print state of the art manufacturing capability for essential pharmaceutical products in Sub-Sahara African countries


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