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Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered ‘objectionable’, and then to…
19 February 2014 | By Allen L. Burgenson, Manager - Regulatory Affairs, Lonza Walkersville, Inc
Allen L. Burgenson, Manager - Regulatory Affairs, Lonza Walkersville, Inc answers the question “From a vendor perspective, do you conclude that Big Pharma is still actively engaging in outsourcing of the activities that you have expertise in?”
3 February 2014 | By Sigma-Aldrich
This pharma webinar provides an overview of how compound profiling using the PLA® (Proximity Ligation Assay) technology can be used for in situ analysis of protein interactions by high content screening as part of the hit-to-lead workflow, the key advantage being the ability to provide evidence for target engagement of…
8 January 2014 | By Rigaku Raman Technologies
This pharma webinar will introduce unconventional approaches to enhance quality programs with the use of modern handheld technology.
In Issue #6 2013: PAT in-depth focus, Lab Automation, Proteomics, Next Gen Sequencing, Screening in-depth focus, Microbiology...
In this Process Analytical Technology (PAT) In-Depth Focus: Presenting a rational approach to QbD-based pharmaceutical development: A roller compaction case study, PAT for pharmaceutical spray drying, PAT Roundtable, Show Preview: IFPAC® 2014...
Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…
Invasive fungal infections associated with high mortality rates are common in hospital settings, especially in intensive care units where patients may be immune-compromised, subject to invasive procedures and treated aggressively with antibiotics. The most common nosocomial fungal infections in descending order are due to the genera Candida, Aspergillus, Rhizopus, Fusarium…
15 December 2013 | By Christos Georgakis, Department of Chemical and Biological Engineering and Systems Research Institute for Chemical and Biological Processes, Tufts University and Gregory M. Troup, Merck Research Laboratories, Merck & Co., Inc
Process Systems Engineering (PSE) has had a profound impact in the chemical, petroleum and petrochemical industry in the last 30 - 40 years. Even though PSE has already started to make a significant impact on the pharmaceutical industry, there are substantial additional benefits that can be derived. The purpose of…
Read the free digital version of Issue #5 2013 of European Pharmaceutical Review magazine...
22 October 2013 | By Diana Russom (Department of Information Technology Systems, Beckman Research Institute of the City of Hope) / Amira Ahmed and Nancy Gonzalez (Laboratory for Cellular Medicine, Beckman Research Institute of the City of Hope) / David L. DiGiusto (Laboratory for Cellular Medicine and Department of Virology, Beckman Research Institute of the City of Hope)
The volume of data generated in modern medical research centres is growing exponentially and becoming more diverse as advancements in automation and biotechnology transform the basic operations of these laboratories and clinics. Patient care and laboratory instrumentation generate data at a rate that rapidly outpaces the ability to track and…
22 October 2013 | By Michael J. Miller, President, Microbiology Consultants, LLC and Suzan Mohammed Ragheb, Department of Biotechnology, The Nile Company for Pharmaceuticals and Chemical Industries
Rapid microbiological methods (RMM) have gained popularity and acceptance within a number of industry sectors, including food and beverages, diagnostics, environmental, personal care and pharmaceuticals. In recent years, many firms have successfully validated and implemented RMMs for a wide variety of applications. However, many geographic areas around the world still…
21 October 2013 | By IDT Biologika
IDT Biologika GmbH, a major developer of pharmaceutical technology and a producer of proprietary and third-party biopharmaceuticals and viral and bacterial vaccines, and Oncotec Pharma Produktion announced investments dedicated to increasing their respective production capacities.
Read the free digital version of the August / September edition of European Pharmaceutical Review magazine...
IN this Informatics In-Depth Focus: Using LIMS for biobanking and implementing LIMS for research; Biologics development and ELN: A good match?; Informatics Roundtable...
