The Column - January 2006 - (Page 9)

Market Trends & Analysis January 2006 www.thecolumn.eu.com The Column Market Profile: Process Analytical Technology in the Biotech and Pharmaceutical Industry conductivity and dissolved oxygen meters. Other technologies The definition of process analytical technology PAT is ...a include particle size analysers, HPLC, mass spectrometry, total system for designing, analysing and controlling manufacturing organic carbon TOC analysers and thermal effusivity, among processes through timely measurements i.e., during others. processing of critical quality and For the most part, those performance attributes of raw and techniques that are simple, in-process materials, to ensure Demand for process analytical technology PAT in robust and that can provide final product quality. In other biotech and pharmaceutical industry instantaneous or relatively rapid words, it includes not just the analysis times with little or no monitoring of any number of 140 sample preparation requirements values or points within a are growing in popularity. manufacturing process, but the 120 Overall, the market for PAT modelling of how all of the inputs instrumentation in the biotech to each process affect the various 100 US$ Millions and pharmaceutical industry parameters and the resulting 80 accounted for about $90 million product and how to apply that in 2003 but has increased model to monitor, analyse and 60 rapidly during the last 2 years. control a given process to produce Some technologies have posted a reliable product. Analytical 40 annual growth rates of over instrumentation and software are 30% and are expected to but tools that can be used to 20 continue solid growth as the pursue an overall PAT strategy. market for PAT in the biotech PAT is not a new approach, but 0 2002 2003 2004 and pharmaceutical industry rather an extension of what is moves forward. commonly known to other The foregoing data was industries as process analytical extracted and adapted from SDi's Market Analysis and chemistry PAC . PAC places the emphasis on understanding Perspectives report entitled The Pharmaceutical and Biotech the process as it relates to the final product. It is an approach Market for Process Analytical Technology PAT . For more that collects analytical information in real time during information, contact Glenn Cudiamat, VP of Research Services, manufacturing via in-, at- or on-line instrumentation. PAC has Strategic Directions International Inc., 6242 Westchester been used in the pharmaceutical industry for decades, albeit Parkway, Suite 100, Los Angeles, California 90045, USA, sparingly. tel. +1 310 641 4982, There are many analytical instruments used in PAT, most of fax +1 310 641 8851, which are molecular spectroscopy techniques like UV/vis, NIR e-mail: cudiamat@strategic-directions.com and IR, and electrochemistry techniques such as pH, Author: Glen Cudiamat E-mail: cudiamat@strategic-directions.com 9 http://www.thecolumn.eu.com

Table of Contents for the Digital Edition of The Column - January 2006

News
Opinion
Market Trends & Analysis
Evaluating Analytical Instrumentation Using the Golf Score Card Tool
ExTech, HTC-9 and Pittcon Focus
Q&A
Supplies and Services

The Column - January 2006