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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.
A US perspective on how pharma companies are preparing for Brexit, overcoming disinfectant residues with culture media neutralisers, unlocking the potential of new technology in biopharma, and much more in this issue of European Pharmaceutical Review.
More guidance is needed on the appropriate control of non-mutagenic impurities during clinical development, explains Dave P Elder, JPAG Member and pharmaceutical industry consultant, in this audio interview.
As part of EPR’s Women inspiring Pharma series, Gowri Sukumar, Associate Director, CMC and Regulatory Affairs at ESSA Pharmaceuticals, talks to Science Editor Dr Zara Kassam about having a positive mindset, diversity and the key to success…
This supplement brings together leading companies with compelling science stories to share in a simple-to-understand format.
This issue recaps the Joint Pharmaceutical Analysis Group's symposium on Continuous Manufacturing, and explores the "perfect technology storm" facing the pharmaceutical sector.
In this issue: the role of bioptherapeutics in curing a range of diseases, and is supercritical fluid chromatography applicable to achiral separations?
In this issue: the applications of vibrational spectroscopy for analysing the molecular component of a solid sample, and Raman as a fast-growing tool for PAT/QbD
In this issue: Microfluidics technology in pharmaceutical research, drug manufacturing and development, and is supercritical fluid chromatography applicable to achiral separations?
As part of EPR’s Women inspiring Pharma series, Liz Barrett, CEO Oncology, Novartis, talks to Science Editor Dr Zara Kassam about finding cures for cancer, identifying meaningful partnerships and acknowledging unconscious biases…
The General Data Protection Regulation (GDPR) is a new set of EU rules governing how a company manages, protects and administers personal data. Whether you are a subscriber, author, advertiser or supplier to our journal, we may hold information about you and we need to keep it private and secure.
Two-dimensional liquid chromatography (2D-LC) has obtained increasing focus over the past two decades. At LEO Pharma, we continuously evaluate new laboratory techniques with the potential to advance our drug discovery and development. We installed a MHC 2D-LC 18 months ago and have found it valuable in a broad range of…
As part of EPR’s Women in Pharma series, Claudia Geis, Head of Region Europe, Ascensia Diabetes Care, talks to Science Editor Dr Zara Kassam about returning to work after maternity leave, setting expectations within a team and sticking to your values…
Developing serialisation programmes is a key concern for pharmaceutical companies. Much of the decision-making is being driven by fast-approaching deadlines for compliance - both in the EU and US.
Limulus amebocyte lysate (LAL) users, compendial experts and regulators are still orienting themselves to the recombinant factor C (rFC) assay. Changes to compendial standards do not occur overnight and, for now, users willing to change must perform the alternative validation procedure USP .
Pyrogen testing of drug products for parenteral administration is a mandatory task. Regulatory authorities require that each batch of drug product is pyrogen-free. Historically, the rabbit pyrogen test (RPT) was the required test but in most cases can be replaced by the endotoxin specifi c Limulus Amebocyte Lysate (LAL) test.
