Gearing up for INTERPHEX

INTERPHEX 2013 is just around the corner, and the show looks to be as big and busy as ever. Our April 24^th issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report discuss advances in various types of equipment used in the pharmaceutical industry, from mixing and blending equipment for solid dosage forms to visual inspection equipment for parenterals and the use of microreactors for chemical API manufacturing.

According to a survey of members of the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable, which was conducted in 2012 (1), that although implementation of continuous processes in pharmaceutical API manufacturing is not a standard practice as of yet, eight of the nine responding companies have taken a continuous process to the pilot plant or production scale. The survey also identified several reasons for implementing continuous processing, including simplification and increased speed of scale-up, increased throughput, and increased safety, reduced waste, greater process control, and overall cost savings.

The problem, of course, is that continuous processing, and particularly the use of microreactors, is a new technology that requires significant investment. With existing capacity and facilities in place for batch manufacturing, it is hard to argue for additional investment even though the benefits are measurable.

Manufactures of microreactors have made progress in addressing many of the concerns associated with their systems. Modular reactors have been introduced that can be fit for different reaction processes and run in parallel to address scale-up needs. Issues, however, remain, such as the need for large numbers of connectors and uncertainty about flow distribution. Integration with downstream processing is also a consideration.

It seems, though, that the use of some sort of flow chemistry for continuous chemical synthesis will eventually be adopted in some form.

Are you surprised by the survey results? Or does your experience fit well with the experience of these pharmaceutical manufacturers? As a microreactor manufacturer, how are you addressing concerns regarding the technology?

You can read more about microreactors for continuous chemical manufacture in the April 24^th issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report.

If you haven’t already, be sure to sign up for the eNewsletter so that you can read what experts in the field have to say. Then let us know what you think.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Reference

1. P. Poechlauer et al., Org. Proc. Res. Dev. 16 (10), 1586−1590 (2012).