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10 March 2015 | By Andrew R. Martin and Warren H. Finlay, University of Alberta
The development of orally-inhaled drug products is a complex endeavour spanning multiple technical and medical fields. For the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), the inhalation delivery route permits the drug to be directly targeted to the afflicted organ, namely the lung. As…
Aqueous, multiple-use, non-sterile drug products are susceptible to microbial contamination during their shelf life. To protect these products from this potential hazard to patients, they are formulated with antimicrobial preservatives. Other product attributes employed using the hurdle concept to prevent microbial contamination include: low pH, low redox potential, reduced storage…
This free-to-view NIR In-Depth Focus reveals the fascinating evolution and future perspectives of near-infrared technology in the lively opening article, plus we examine the benefits of combining NIR spectroscopy with process analytical technology...
In Issue #6 2014: Polymerase Chain Reaction, Imaging, PAT in-depth focus, Screening in-depth focus, Microbiology Series and much more...
This free-to-view Screening In-Depth Focus is packed with articles that will give you a greater understanding of interesting topics such as the identification of compounds that protect against free radicals, advancements in sandwich immunoassay techniques and hit validation and optimisation...
This PAT In-Depth Focus explores current challenges posed by the slow uptake of Process Analytical Technology within the pharmaceutical and biopharmaceutical industries. The advantages of incorporating PAT into the pharmaceutical process are highlighted in two informative articles, and possible solutions to its lack of popularity surmised...
23 December 2014 | By Eurofins BioPharma
The largest network of harmonised bio/pharmaceutical gross manufacturing product (GMP) testing laboratories worldwide, Eurofins BioPharma Product Testing enables companies to advance candidates from development through to commercialisation while ensuring regulatory compliance, cost effectiveness and achievement of timelines...
23 December 2014 | By Axel Ducret, Biochemist
This article will focus on some of the critical aspects of transition biomarkers discovered in classical (MS-based) proteomics workflows and on the challenges to be met before validated assays can become more routine in the clinical laboratory...
23 December 2014 | By Dr Tim Sandle, Bio Products Laboratory
This article surveys some of the recent developments in regulatory requirements and standards that have taken place during the past 12 months, highlighting those aspects that are of relevance to pharmaceutical microbiology...
23 December 2014 | By Paul McCracken & Stephen Krause
The cost of drug discovery and development, depending upon the size of a given company, has been estimated upwards of $5 billion. Hay et al. recently published a review of clinical development success rates showing only a 10.4% likelihood of regulatory approval of all drugs entering Phase I, 64.5% of…
23 December 2014 | By Natalia Meani and Manuela Vecchi
Recognised as one of the major scientific breakthroughs of the 20th century, polymerase chain reaction (PCR) is a quick and simple method to create, in a test tube, millions of copies of a given DNA segment from a complex mixture of genetic material. This method has greatly stimulated biochemical, molecular…
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
In this issue: Protein Characterisation, RMM, Flow Cytometry, Spray drying, NMR spectroscopy, Raman, Pharmaceutical salts, Sterile Control Strategies and much more...
Michael J. Miller discusses rapid microbiological methods and the regulatory environment, the Online Water Bioburden Analyzer Workgroup look at the path to implementing Online Water Bioburden Analyzers, plus RMM roundtable...
Sulaf Assi discusses the investigation of medicine quality using handheld Raman spectroscopy, a look at Raman hyperspectral imaging, plus Raman roundtable...
