Several organisations have developed guidelines that specifically address genotoxic impurities in pharmaceutical products. Here, Dr Sol Bobst and Gowri Sukumar discuss the regulatory landscape, testing requirements and calculation methods for occupational exposure limits.
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Issue 6 2019
Clinical microbiologists have started using new, non-conventional methods to study the microbiology of the human gut. In this article, Jeanne Moldenhauer discusses the intricacies of culturomic and metagenomic studies and how this can advance current research.
Since it was discovered in the 1920s, Raman spectroscopy has been used in pharmaceutical research as a non‐invasive way to provide chemical and structural information in situ, without any staining or complicated sample preparation. Nikki Withers spoke to Professor Kishan Dholakia to hear more about its use in industry and…
Faced with the looming deadline for compliance of May 2020, many medical device companies still haven’t fully grasped the impact of the new EU Medical Device Regulations (MDR) across all their product labelling. The requirements also affect what goes on Information-for-Use (IFU) leaflets and electronic equivalents. Here, Graham Francis offers…
Drug safety is a huge concern for big pharma and tampering and counterfeiting in the market is dangerous for both consumers and brands. In this article, Prakash Shetty shares the latest innovations in packaging design and highlights how tamper proofing and developments in technology can protect all concerned.
Mergers and acquisitions in any market can define the landscape for its players. In this article, Emma Danks of Taylor Wessing reflects on recent M&A activity in the biopharmaceutical industry, highlighting influencing trends and what this might mean for the future.
The first gene therapy products are appearing commercially and the field is growing rapidly with over 350 clinical trials taking place in H1 of 2019 alone. So why is this area attracting so much attention? Dr Philip Probert and Dr Stuart Jamieson discuss the potential of gene therapy and the…
Nanobots have the capacity to precisely release drugs in the body for targeted delivery. Victoria Rees investigates several new developments in the nanobot field, to discover recent advances and how nanobot drug delivery systems may continue to evolve.
Formulation confidence with recombinant albumin: the benefits of a versatile stabiliser for challenging formulations
The path to formulation of pharmaceuticals is not always straightforward, especially as products are becoming increasingly complex. Recognising strategies with the greatest advantages and considering all the options available to get the best drugs to market can greatly facilitate drug development and formulation. This article will demonstrate how recombinant albumin…
Partnering for product characterisation can streamline drug development and create efficiencies in moving from concept to clinic.
Application note: TOC for cleaning validation: swab recoveries of worst-case compounds (feasibility testing)
THE PARENTERAL Drug Association Technical Report No. 49 serves as a resource to help guide the development and evaluation of a cleaning validation programme.
Vapour-compression-based WFI production has a total cost of ownership that is less than or equivalent to that of a membrane-based system and significantly less than that of a typical multiple-effect-based system. The following whitepaper provides examples that illustrate system designs that are relatively basic, yet typically sufficient.
Application note: Non-targeted host cell protein monitoring in downstream process samples using micro Pillar Array Columns combined with mass spectrometry (μPACTM-MS)
This whitepaper reports on the use of μPAC™ in combination with MS for the characterisation of HCPs and their monitoring during downstream processing.
WITH THE RISE of metabolites/molecules production using complete living cells or their components (bacteria, enzymes, chloroplasts, etc), which is also termed bioprocessing, it has become increasingly important to control the different production steps and analyse the different biological materials.
Pharmaceutical and biotechnology manufacturers must ensure the quality of materials – from incoming raw material through finished product.