Monthly Archives: March 2017

Best Practices for Sampling of Pharmaceutical Water: New ISPE Good Practice Guide

By | March 15, 2017

Sampling of pharmaceutical water is a required activity that has historically relied on the expertise of those responsible for developing and implementing the sampling procedures and/or plan. Sampling provides proof that a system producing water for pharmaceutical applications is operating under control and that the water being used is of suitable quality for the intended… Read More »

Continuous Biopharmaceutical Manufacturing – Possible, Improbable, or Unavoidable?

By | March 6, 2017

I don’t remember a lot of effort going into learning about batch processing in my chemical engineering studies.  Continuous processing was the norm in refineries and many chemical plants.  Steady state equated to even quality, and output could be tuned for maximum efficiency.  The world revolved around a well understood material balance.  Batch was for… Read More »

Transforming Downstream Processing through Multi-Column Chromatography

By | March 6, 2017

The call for implementing continuous processing in the manufacturing of bio-pharmaceuticals requires re-thinking of process chromatography and its equipment design. Proof-of-concepts of innovative multi-column continuous processes were introduced by the industry, which verified improvements in resin utilization and increased productivity [1]. Now, these concepts are transferred and verified at the pilot and production scale. First… Read More »

USP Updates Informational Chapter <1231> on Pharmaceutical Water

By | March 2, 2017

For those who have an interest in pharmaceutical waters, the recently released USP 39 Supplement 2 includes an updated Informational Chapter <1231>. This new and improved chapter has been rewritten and reorganized including a new table of contents, added hyperlinks for contemporization and ease of use, clear and concise technical explanations, and additional material including… Read More »

Career Development – How to Get Started

By | March 1, 2017

Career development in the biotech/pharma industry is very exciting and full of opportunities.  One reason is because the industry has many facets to it – it attracts scientists, doctors and engineers, as well as business professionals in sales, marketing and general administration.  The other reason is because many people in the biotech/pharma industry are energetic… Read More »