R&D PARTNERSHIP IN INTEGRATIVE PROCESS ANALYTICAL TECHNOLOGIES TO BENEFIT PHARMACEUTICAL INDUSTRIES

A research collaboration agreement between the Institute of Chemical and Engineering Sciences and National Instruments Singapore Pte Ltd. to study Integrative Process Analytical Technologies (iPAT).

Singapore, 23 January 2007 – The Institute of Chemical and Engineering Sciences (ICES), a research institute under the Agency for Science, Technology and Research (A*STAR), signed a research collaboration agreement today with National Instruments Singapore Pte Ltd. (NI), the regional branch of National Instruments headquartered in Austin, Texas, USA, to study Integrative Process Analytical Technologies (iPAT). The research collaboration agreement was signed by Mr Chandran Nair, Managing Director of Southeast Asia of National Instruments Singapore Pte Ltd. and Dr Keith Carpenter, Executive Director of ICES. This is NI’s first collaboration with a local research institute.

The collaboration is part of a research programme in ICES to develop integrated systems to apply advanced analytical and control techniques to chemical and pharmaceutical development and manufacturing, which will be compatible for use from laboratory through pilot plant to industrial scale operations. This iPAT development supports ICES research into Process Analytical Technology (PAT) applied to Pharmaceutical cGMP (current Good Manufacturing Practice) for the 21st century recently initiated by the U.S. Food and Drug Administration (FDA).

The pharmaceutical industry is presently undergoing a major shift in manufacturing and R&D practice. The developing role of PAT in R&D includes the application of modern analytical technologies and computational methods for process invention and optimisation and knowledge management. The effectiveness of R&D is greatly enhanced by early understanding of the complex reaction mechanisms and physical chemistry made possible by the sophisticated measurements being performed. PAT also impacts current manufacturing practice by improving process robustness and reducing the amount of product that fails the very stringent pharmaceutical specifications. Enhanced knowledge management enables detailed archived records of the processes to be available to support regulatory review.

ICES houses leading research teams in analytical techniques, synthetic chemistry, physical chemistry and chemical engineering, all integrated into one organisation. It is therefore in an ideal position to invent and to apply new PAT technology, from lab to kg scale. As for NI, the company has been a technology pioneer and leader in virtual instrumentation which increases productivity and lowers costs for test, control and design applications by leveraging PCs and commercial technologies.

Under the terms of the agreement, NI will use their technologies, technical expertise and global network to provide technical support to ICES researchers and will provide some equipment and system development. NI will benefit by extending their existing capability to the pharmaceutical and chemical industries, particularly in PAT applications. NI will designate a research engineer to work with ICES researchers on the joint programme.

Mr Chandran Nair said, “We recognise ICES’ strategic role in Singapore’s chemical and pharmaceutical R&D and see them instrumental in the adoption of the new framework for innovating pharmaceutical manufacturing and quality assurance, especially with the major paradigm shift in manufacturing and R & D that has been introduced by FDA. This collaboration is a means to integrate the latest technologies to the pharmaceutical industry which for many years has been bound to antiquated technology. We hope it will show the pharmaceutical industry the benefits of increased yield and enhanced quality by the adoption of the latest technologies.”

In this collaboration, NI will work closely with the Advanced Reaction Engineering, Process Analytics and Chemometrics (AREPAC) team in ICES. AREPAC has considerable experience and capabilities in in-situ spectroscopic monitoring and analysis of chemical reactions. This combined instrumental and computational ability for understanding complex chemistries, particularly at the R&D stage, can be further extended through the present collaboration. The combined expertise of NI and ICES will further advance developments in PAT.

This project marks the first collaboration ICES has with a multinational electrical engineering hardware and software company and it is one of the many industrial collaborations the young institute has successfully secured since its inception in October 2002. The present ICES collaboration is the first focusing on chemometrics and PAT, in contrast to established collaborations in the areas of catalysis, chemical synthesis etc.

Dr Keith Carpenter commented, “We are excited to work with NI on this project. By combining their expertise in data acquisition hardware and graphical programming software such as LabVIEW, and our expertise in process analytics and chemometrics, I am sure that through this collaboration we will be able to pioneer the adoption of novel and advanced PAT techniques by the pharmaceutical and chemical industries in Singapore.”

For more information, please contact:
ICES
Ms. Hera Adam
Institute of Chemical and Engineering Sciences
Tel: 6796 3894
Fax: 6873 4805
Email: [email protected]

NI
Elizabeth Ee
National Instruments
Tel: 6226 5886
Fax: 6226 5887
Email: [email protected]

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