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Articles

Versatile miniaturised HTS

7 March 2005 | By Oliver Bruttger, Danielle Folio, Christine Niklaus and Johannes Ottl, Novartis Institute for BioMedical Research, Lead Discovery Center Basel

Research and development for a pharmaceutical company is a difficult and lengthy process. It stretches from the discovery phase to preclinical and clinical development stage, through the drug approval period ultimately to clinical application. The discovery research phase is one of the early key processes. The research starts with target…

PAT for API

7 March 2005 | By Dirk C. Hinz, Ph.D., Schering AG, Corporate CMC Development, In-Process Control Dept.

Pharmaceutical manufacturing occurs in a highly regulated environment, where most of the manufacturing is performed in batches, in stop-and-go steps and with off-line testing of product quality. Additionally, due to patent restrictions, there is always ‘speed to market’ pressure.

Excellence by design

7 March 2005 | By Simon Routledge, Head of GMP Manufacturing, Eden Biodesign

A desire to build on the bio-manufacturing expertise already present in North West England and the requirement to support UK biotechnology growth as a whole has led the North West Development Agency to sponsor the establishment of a National Biomanufacturing Centre (NBC) in Liverpool. The NBC is due to open…

Management strategies for risk assessment

7 March 2005 | By Dr Monika Sauter, Director, Global Quality Assurance Operations and Tim Lloyd, Editor

A safe, effective and state-of-the-art cleanroom requires significant investment and manpower. To sustain long-term development and meet objectives, as well as maintain a contamination-free environment, it is essential that sound procedures are in place from day one, as part of a dedicated management program.

Who nose?

7 March 2005 | By Professor Richard Dalby and Yang Guo, University of Maryland School of Pharmacy, Julie Suman, Next Breath LLC

In 2003 worldwide sales of allergic rhinitis nasal sprays alone were valued at US$2.4B (IMS, Valois), up from 2002 worldwide sales of all over-the-counter (OTC) nasal sprays except steroids, estimated at US$820M (IMS, Valois). That’s a significant amount of drug administered via the nose every year (Figure 1). With a…