So you want to build a new facility for advanced therapy manufacture? Before you start building, there is one essential element that you need to get right: site selection.
Read MorePeter Walters
Fellow - Advanced Therapies
San Diego, CA
Peter Walters is a process engineer with 18 years of experience specializing in pharmaceutical process and facility design. He has designed equipment and processes for the multi-step manufacturing of pharmaceutical drug products, performed scale up of aseptic bulk process to various capacities and product manufacturing for clinical studies in phases I, II and III. His experience includes the design, development and validation of clean-in-place and sanitize-in-place processes for aseptic bulk production systems. Peter has extensive experience with CGMP manufacturing, including generation of procedures and batch records, validation of systems and processes and the manufacture of clinical and commercial products.
His expertise includes experimental design, process characterization, equipment and process troubleshooting and manufacturing for clinical phase I through commercial production. He is well versed in production performance and process and product analysis. He has designed process facilities for monoclonal antibodies, gene therapies, autologous and allogeneic cell therapies and aseptic novel processes, in both stainless steel and single-use equipment. He has helped author a New Drug Application and has participated in Food and Drug Administration facility inspections. He is a co-inventor for a patented novel product formulation process. Peter was recognized by Consulting-Specifying Engineer with the 40 Under 40 award in 2018.
Throughout his career, Peter has taken a particular interest in opportunities for creativity. With his commissioning and pilot-scale experience, he has a strong talent for understanding equipment use and troubleshooting.
Peter graduated from the University of California, Davis with a degree in chemical/biochemical engineering. He is a Southern California native and enjoys playing soccer and spending time with his family in San Diego.
Insights By Peter
4 cell therapy manufacturing approaches: your guide to optimizing every square foot
Could your cell therapy manufacturing facility be working harder for you? If you have (or anticipate having) small-scale cell therapies in your pipeline, this question is vital.
Read MoreFill-finish in ATMP: 5 critical questions to ask on the way to process scale-up
To bring the exciting science of cell and gene therapy manufacturing to life, creating smaller-scale filling solutions is imperative to the success of the ATMP industry. But before you begin scaling your operation, there are important questions to consider about fill-finish in ATMP.
Read MoreDesigning multimodal GMP suites
Considerations for dedicated and campaigned use
Read MoreThe future of cell and gene therapy
The future of cell and gene therapy and defending our global population from disease—those we know and those to come—requires new nimbleness for development and manufacturing.
Read More