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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
Sample preparation – is it possible to have too much?
In the field of bioanalysis, the use of sample preparation is fundamental to ensuring that data is robust. This article looks at some of the various forms of sample preparation that are commonly used for the pre-treatment of biological fluids and considers the advantages and disadvantages of each approach.
Guide to Outsourcing
Welcome to European Pharmaceutical Review’s Guide to Outsourcing, the fourth in our series of ‘Guide to…’ supplements. In this edition, five leading companies that provide outsourcing services explain how their portfolio meets current industry needs.
A paradigm change in biologics microbiological contaminant control
Contaminant detection methods derived from the innate, proinflammatory responses of rabbits and Limulus blood have been used to determine the existence of microbial artefacts in small-molecule drugs (SMDs) and large-volume parenterals (LVPs) for decades...
Issue #5 2017 – Digital Version
In this issue: Sample preparation - is it possible to have too much? Developing successful over-the-counter syrup packaging for the highly regulated EU market. In-line process PAT in continous wet granulation, and much more...
Paying it forward in PhRMA
As part of EPR’s Women in Pharma series, Lori Reilly, Executive Vice President, Policy, Research & Membership, talks to Science Editor Dr Zara Kassam about the importance of having strong female mentors...
Ensuring successful serialisation data management ahead of the EU FMD
Traceability and serialisation have been the talk of the industry for many years, with regulatory bodies worldwide starting to introduce legislation that will help to eradicate counterfeit medicines from the supply chain.
Turning challenges into solutions at Merck
As part of EPR's Women in Pharma series, Petra Wicklandt, Senior Vice President, Head of Global Chemical and Pharmaceutical Development, Merck, talks to Science Editor Dr Zara Kassam about facing challenges in the pharmaceutical industry and turning them into solutions...
17th-century style science in the 21st century? The case of the Alzheimer’s disease vaccine
Dante J Marciani, President and CSO of Qantu Therapeutics, reviews the current evidence and controversy in the hunt for a vaccine against Alzheimer's disease and considers the future.
A comprehensive review of the newly revised European Pharmacopoeia chapter 5.1.6
European Pharmacopoeia Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, was recently revised and published in Ph. Eur. Supplement 9.2. The new chapter comprises a number of significant changes from the original version published in 2006. Prior revisions to a similar chapter and technical report from the USP and…
Compressed gases: an important component of an environmental monitoring programme
The quality attributes of manufactured pharmaceutical products include the physical, chemical, and microbiological characteristics of the raw materials, excipients and active pharmaceutical ingredient (API), as well as the final drug product (see Table 1). Absence of microbiological contamination is considered a critical quality attribute due to its potential to dramatically…
QA/QC In-Depth Focus
In this In-Depth Focus: Quality control of freeze-dried oral formulations; Regulatory and quality assurance challenges in continuous manufacturing...
Environmental Monitoring In-Depth Focus 2017
In this in-depth focus: Compressed gases - an important component of an environmental monitoring programme; The people factor - contamination of cleanrooms caused by personnel...
Guide to Ingredients
In this guide to ingredients, two leading companies involved in testing and analysis explain how their service offering meets current industry needs...
Extractables – leachables correlations for packaging
Plastic materials, widely used in pharmaceutical packaging systems, can interact with the packaged product by transferring leachables. Leaching is important, as foreign leachable impurities can adversely affect the quality, efficacy and safe use of the packaged product, due to their chemical or physical nature, reactivity, and/or toxicity.
Biopharmaceutical Development & Processing In-Depth Focus 2017
In this in-depth focus: Non-contact single cell adhesion and micromechanical property characterisation with ultrasound. Is high resolution mass spectrometry the missing piece in continuous bioproduction? Regulatory, clinical and logistics challenges of ATMPs in clinical research...
