Peter Calcott

A native of the UK, Dr. Calcott has a career spanning 4 decades and has worked for Pharma companies such as SmithKline Beecham, Monsanto and Bayer as well as biotechnology companies such as Immunex, Chiron and PDL. He has held positions in R&D, Manufacturing, QA & QC, Process Development, Corporate Compliance, Business Development, and Government Affairs. He has worked on biologics (vaccines, recombinant proteins, monoclonal antibodies, blood products), drugs and generics from early development to commercial. Prior to entering industry he taught at university. He is a member of the Board for BayBio and is chairman of the RAC committee of BIO. Dr. Calcott has a BS from University of East Anglia and D.Phil from University of Sussex in the UK. While in Academia he was a consultant to University, government and industry. He has published over 90 research articles, reviews and books.

Posts by Peter Calcott:

• The new EU Process Validation Guidance and what it says

  28 Feb 2013 in Commercial Manufacturing & News & Process Validation & Quality by Design & Risk Management

  The initial draft of the EU Guidance for Process Validation was released for comment and the comment period closed in October. So what has the thoughts on the new guidance since it was released? Read the linked article in Master Control on line journal for some insights.

• Quality by Design in the Vaccines world

  18 Feb 2013 in Clinical Manufacturing & GMP & Process Validation & Quality by Design & Risk Management

  In February I published an article on the topic of Quality by Design as it applies to the Vaccines World. This was based on a presentation at an IBC conference on vaccine development. As you might imagine, QbD has been slow in development of biologics but even slower in Vaccines. Check out the article on […]

• What are the requirements for shipping products?

  12 Dec 2012 in Commercial Manufacturing & GMP & News & Webinars

  Pharmaceuticals are notoriously heat labile; at least many of the new high tech ones. Many require cold temperature storage at 2-8C. While they can withstand higher temperature for short periods of time, the shelf life of the products is defined by the recommended storage temperature of 2-8C. With that understanding, is it acceptable to routinely […]

• Regulations versus Good Business Practices

  30 Nov 2012 in Commercial Manufacturing & GMP & News & Webinars

  It has come to my attention in webinars I present, mostly through The Tungsten Shield Group, classes I teach at University of California and my consulting work, that many people have lost sight of what their goals should be. When we develop systems, put controls in place, monitor processes, we do it because it makes […]

• How is clinical manufacturing different from commercial

  10 Sep 2012 in Clinical Manufacturing & GMP & News & Risk Management & Webinars

  At a recent webinar presented by Tungsten Shield on the topic of the differences between Clinical Manufacturing and Commercial, one question perplexed me.  It went something like this: You advocate using less resources to release a commercial lot of material than a clinical lot and you point to Risk Management techniques.  Surely, the commercial lot […]