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Whether by ignorance of the latest best practices, or willful disregard for patient safety, the results of careless practice can often be fatal. The articles in this in-depth focus highlight how regulatory bodies are taking action to raise the industry’s game.
In this edition, two companies showcase their services and highlight how they stand out from the crowd. The exponential speed of the information technology evolution is rapidly being accepted and integrated into our everyday life, yet it remains a challenge in the laboratory.
ACD/Labs helps scientific R&D organisations assemble digitised analytical, structural and molecular information for effective decision-making, problem solving and product lifecycle control by their scientists. Their enterprise technologies enable automation of molecular characterisation and product development, and facilitate chemically intelligent knowledge management, data analytics and collaboration – both within organisations and…
With a continual focus on data integrity and helping our customers meet regulations while generating actionable insights, Particle Measuring Systems provides a complete range of products and services.
Analytical techniques for QA/QC purposes are integral to the safe production of therapeutics. This in-depth focus looks at Raman spectroscopy for amorphous phase analysis and discusses the viable but non-culturable (VBNC) state of bacteria in environmental monitoring.
The process of manufacturing a biotherapeutic drug entails numerous quality control measures to ensure safety and efficacy. The articles in this in-depth focus discuss higher order structure analysis and host cell protein contamination issues.
The latest research and developments from Pharma and Biopharma industry experts.
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.
This in-depth focus looks into industrial workflow processes and also how nature can provide inspiration for drug delivery.
The increasing complexity of formulations and active biological products raises new challenges for pre-filled syringe development. James Mellman, Device Manager at Novartis, speaks to Nikki Withers about the challenges of selecting the right primary packaging for injectable formulations and how he has learnt to expect the unexpected.
In this issue we explore reasons behind critical key drug shortages in the EU, whether viability methods effectively detect all viable organisms and how companies can future-proof their digital technologies ahead of Brexit. Also included are articles on higher order protein structure, FMD compliance and Raman spectroscopy.
As Gilead Sciences enters the rheumatology space, Dr Michael Elliott, Vice President, Medical Affairs Europe, Middle East, Australia & Canada, discusses how Gilead is looking to rapidly build an experienced and committed team to address the unmet medical needs of people living with inflammatory disease.
As the pioneers of the Limulus amebocyte lysate (LAL) testing methodology, Associates of Cape Cod, Inc. (ACC), specialises in bacterial endotoxin and (1→3)-ß-D-glucan detection, using FDA-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
An important step in the research and development of biopharmaceuticals is to identify molecules with favourable physical and chemical stability profiles. Yongchao Su, Wei Xu and Bruce Yu discuss how solution, solid-state and benchtop nuclear magnetic resonance (NMR) methods can provide advanced biophysical characterisations of biological products.
