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In this article, Dave Elder reviews the European Medicines Agency (EMA)’s updated reflection paper on the qualification of non-mutagenic impurities (NMIs), which outlines alternative approaches to animal testing.
Kaiser Optical Systems provides Raman analysers and fibre-optic probes for pharmaceutical applications ranging from laboratory discoveries to process control. Working with Kaiser is an opportunity to benefit from its experience and knowledge in Raman spectroscopy, chemometric model development, bioprocessing and pharmaceutical analysis.
Sievers products, now part of SUEZ, meet the needs of the pharmaceutical industry with services ranging from validation support and application expertise, to certified reference materials, custom standards, and on-site services.
In this series, our Science Editor Dr. Zara Kassam, interviews influential decision-makers and female leaders within the pharmaceutical industry, as they discuss their careers, the challenges they’ve faced and the importance of breaking through self-imposed barriers...
As part of EPR’s Women in Pharma series, Elaine Chiquette Head of Science at Gelesis, Inc, talks to Science Editor Dr Zara Kassam about positive challenges, embracing responsibilities and being committed to your goals…
In parallel with the use of a wide range of antibiotics for treating infectious diseases worldwide, antimicrobial resistance has significantly increased. For this reason, the application of an advanced pangenomic technique like DNA microarray can be an effective, rapid, accurate, sensitive, specific and flexible methodology for detecting, identifying and determining…
In this edition, two leading analytical equipment suppliers explain how their products meet current industry requirements.
This In-Depth Focus looks at the benefits of mass spectrometry for the characterisation of protein higher order structure and for stability testing.
This In-Depth Focus on near-infrared spectroscopy considers analysis using an innovative SAR-DRM and explores advances in technology that have an application on PAT/QbD.
This Packaging In-Depth Focus explores the risks around interactions between drugs and their packaging and looks at how smart packaging may help patients take their medication accurately.
In this issue: DNA microarray for detecting, identifying and determining antimicrobial-resistant bacteria; the advantages of single-use technology and a framework for an implementation strategy; risk management when designing chemical safety assessments for pharmaceutical packaging systems.
12 February 2018 | By Scott Rudge, COO, RMC Pharmaceutical Solutions Inc
Single-use systems have become an important tool in the development and scale up of biotechnology processes. Single-use systems save space, increase flexibility in scale and space planning and, to a large extent, eliminate cleaning costs in development and change over. However, single-use systems come with their own challenges, including complete…
Human brains have to manage an inconceivably massive amount of information. By current estimations, we are offloading, transferring, and storing information upward of 2.5 quintillion bytes a day...
The prevailing view would perhaps be that the industry is not good at innovation, because it is conservative and risk averse. BPOG Director Simon Chalk shares his own views.
By combining Patheon’s capabilities in drug development and manufacturing with its clinical trials packaging and logistics expertise, Thermo Fisher will be able to provide an end-to-end solution for its biopharma customers. Dr John Rontree, Senior Director of Marketing, Pharmaceuticals and Biopharmaceuticals, Thermo Fisher Scientific, discusses his company’s plans.
Quality by Design (QbD) is a method approach to developing a quality control system using predetermined objectives. It uses the foundations of risk management and science to ensure a repeatable process to manufacture high-quality products. In 2002, the FDA launched QbD as part of its innovation initiative. This paper outlines…
