List view / Grid view
22 August 2005 | By Joep Timmermans, Ph.D., Senior Manager/Team Leader, Process Analytical Support Group – Americas Implementation Team, Pfizer Global Manufacturing
While the current attention and focus on Process Analytical Technologies (PAT) may make you believe otherwise, PAT measurement systems have been used in the pharmaceutical industry, Pfizer included, for some time, albeit often to a limited extent.
22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting
Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.
22 August 2005 | By Michel Philippart, Director, Sourcing & Procurement, GlaxoSmithKline Biologicals s.a.
In today’s challenging environment, aggressive cost control has become a common theme in the pharmaceutical industry.
22 August 2005 | By Professor Naomi E. Chayen, Biological Structure and Function Section, Division of Biomedical Sciences, Imperial College London
We are currently living in an exciting age, where for the fist time ever, human diseases are being understood at a molecular level. Protein crystallography plays a major role in this understanding because proteins, being the major machinery of living things, are often the targets for drugs.
22 August 2005 | By Dr Johannes Ottl, Laboratory Head, Novartis Pharmaceuticals
The pharmaceutical industry continues to face an ever-changing, increasingly competitive business environment. This makes it imperative for drug discovery and development efforts to incorporate new technologies in order to reduce time-to-market to survive in today’s competitive marketplace. This industry pressure to shorten the R&D process has seen high-throughput screening (HTS)…
20 May 2005 | By Jeroen DeGroot, PhD; Anne-Marie Zuurmond, PhD, Daniel Eefting, MD; Ruud A Bank, PhD; and Paul Quax, PhD.; TNO Quality of Life, Business Unit Biomedical Research
All diseases have a genetic component, whether inherited or resulting from the body's response to environmental stresses such as viruses, toxins or trauma. The successes of the human genome project have enabled researchers to pinpoint errors in genes that cause or contribute to disease.
20 May 2005 | By William Carley, Ph.D., Experimental Medicine, Pfizer Global R&D
Biomarker application during drug development is driven by the need to define disease and therapeutic efficacy/safety earlier, better and with reduced cost.
20 May 2005 | By Laura Hohmann, Research Associate, Daniel Martin M.D., Director, Proteomics Facility, The Institute for Systems Biology
The past decade has witnessed an explosion in the field of proteomics. This development has been driven by the development of database search algorithms, expansion of sequence databases and improvements in mass spectrometry instrumentation. Quantitative techniques using isotopic dilution have allowed quantitative experiments. The expanding opportunities have propelled the development…
20 May 2005 | By Jianwei Liu and Clay W Scott, AstraZeneca Pharmaceuticals, Wilmington, USA
Receptor-ligand binding assays are extremely powerful tools in drug discovery. With advances in technology and methodology, the traditional radioligand filtration assays are being replaced with higher throughput homogeneous assays. Non-radioactive methods have been developed recently that are particularly applicable to early phase drug discovery.
20 May 2005 | By Peter Hodder, Ph.D., Director & Head of Lead ID, Scripps Florida
In pharmaceutical drug discovery research, several technological advances have moved in vitro biological and biochemical experiments from the laboratory benchtop to fully automated high-throughput screening (HTS) robotic platforms1,2.
20 May 2005 | By Peter B. Simpson, Senior Research Fellow – Automated imaging, Neuroscience Research Centre, Merck Sharp and Dohme
In drug discovery for CNS diseases, the use of complex neural cell culture systems offers many advantages. Innovations in high content screening enable us to identify compounds which affect key cell biological properties in such cultures. We can bridge the divide between kinetic and endpoint screening by use of another…
20 May 2005 | By Derek J. Trezise, Assay Development & Compound Profiling, GlaxoSmithKline Research & Development
The advent of higher throughput patch clamp electrophysiology systems has begun to change the face of ion channel drug discovery. Systems such as IonWorksHT, PatchXpress and QPatch should allow electrophysiology to be re-positioned from an occasional reagent and compound ‘spot-check’ method, to a frontline gene expression analysis tool and drug…
20 May 2005 | By Bernhard Schrader, Institut für Physikalische und Theoretische Chemie, Universität Duisburg-Essen and Hartwig Schulz, Federal Centre for Breeding Research on Cultivated Plants, Institute of Plant Analysis
Raman spectroscopy using excitation in the near infrared allows non-destructive Raman analyses of pharmaceutical products as well as of plant or animal tissues. This radiation excites only minimal fluorescence of the samples or impurities and has only minimal photo-physical and photochemical activity. Raman analysis of plants allows the efficient exploration…
20 May 2005 | By Ali Afnan, Ph.D., Process Analytical Technologist, FDA/CDER/OPS
The pharmaceutical industry plays a major role in the lives of individuals by providing critical therapeutic medicines. This places the industry in the public eye, as does drug pricing, safety and efficacy, the stock markets and courting with several different regulatory bodies, with differing legal requirements, around the world. The…
20 May 2005 | By Paul J Newby PhD, GlaxoSmithKline R&D
In the last decade interest in Rapid Microbiological Methods (RMMs) has grown considerably. Technologies such as ATP bioluminescence, solid phase laser cytometry and genetic-based identification systems are being vigorously investigated. Validation and regulatory requirements for such new technologies are beginning to emerge. However, there is a lot of confusion and…
