Raman In-Depth Focus 2018
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
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Articles
Issue 3, 2018
In this issue: Microfluidics technology in pharmaceutical research, drug manufacturing and development, and is supercritical fluid chromatography applicable to achiral separations?
Liz Barrett, Novartis: ‘My personal mission is to help find cures for cancer’
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…
European Pharmaceutical Review: Our 5 Steps to GDPR Compliance
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) with multiple heart-cutting
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…
Agility and Broad Understanding of Business Drive Success
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…
Serialisation: Thinking global, acting local
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.
Specificity in the recombinant factor C test for endotoxin
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 .
The changing environment in pyrogen and endotoxin testing
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.
The latest trends in pharmaceutical microbiology
There have been many changes in pharmaceutical microbiology as we progressed into the 21st century. Some of these changes have been due to the advance of rapid microbiological methods, knowledge gained from the study of the human microbiome, while others are changes to conventional testing methods. This paper discusses some…
Wickham Laboratories Ltd: backed by five decades of global experience
Wickham Laboratories Ltd, backed by five decades of global experience in Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) contract testing, is an established name in the fields of pharmaceutical and medical device contract testing, research and consultancy. We conduct business with clients worldwide and the combined expertise of…
Eurofins: Designed to give clients laboratory services support
Eurofins’ PSS Insourcing Solutions® (PSS) employs and manages full-time scientists, managers and support staff to perform a defined scope of work at a client’s facility.
Charles River: Data drives every decision in the lab to support confident decisions
Charles River Microbial Solutions believes data drives every decision in the lab, so ensuring it is accurate, relevant, and reliable is critical to support confident decisions on product quality and safety.
Butterworth Laboratories Ltd: Analytical chemistry services for the global pharmaceutical industry
Butterworth Laboratories Ltd is a UK-based contract laboratory providing analytical chemistry services to the global pharmaceutical industry in support of R&D, clinical development and licensed manufacture. We are GLP, GCP and GMP compliant, FDA and MHRA inspected.
Associates of Cape Cod: Comprehensive consultation, validation, training, and support
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 Food and Drug Association-licensed chromogenic, turbidimetric and gel-clot reagent technologies.
