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A thorough understanding and control of extractables and leachables in liquid and semi-solid products has long been a regulatory requirement.1,2 Regulatory guidelines require that product contact surfaces are “not reactive, additive or absorptive”.3
In this issue: Miniaturisation of freeze drying equipment, driving excellence in premises and equipment management, a guide to ingredients, and much more...
Scale-up and manufacturing strategy for insect cell culture (ICC) should be assessed at the earliest stages of process development. Your final goals will shape the process and determine at what stage to implement steps that can make the process more reliable and robust at manufacturing scale. Sharyn Farnsworth, Associate Principal…
Bringing a biosimilar from early development to market is a risky endeavour say Magnus Franzen (left) and Chris Isler, biosimilar experts at PA Consulting Group...
An exclusive column from the ABPI's Magda Papadaki about the implications of synthetic biology for the pharmaceutical industry...
Consistent with quality-by-design (QbD), and driven by the desire for continuous manufacture and real-time lot release, biopharmaceutical manufacturers require advanced process analytical technologies (PAT) for process monitoring and rapid analytical information generation.
An effective environmental monitoring programme is designed to estimate the microbial content of the room’s air and surfaces (by incident rate, against alert and action levels, and by assessment of different species) for operations performed within a cleanroom or controlled environment.
Veeva's Rik Van Mol explains how streamlining the clinical process will not only improve the speed but also the quality of the data...
David Edwards explains how Agilent spectroscopy systems combine core qualities of robustness and reliability with a spirit of innovation.
Global Heat Transfer's MD, Clive Jones, gives 3 considerations for manufacturers operating thermal fluid heat transfer systems to safeguard the system’s future for the long term.
The demand for drug and alcohol testing in the UK is at an all-time high and the market is growing rapidly, says Livingstone's Barry Sheehan...
Life Sciences and Healthcare supply chains need transformation to support the increasing cost pressures and consumer demands for new and more convenient, affordable care models…
Patheon’s Joe Principe examines current trends in outsourcing, highlighting the importance of investment in CDMO partnerships...
In this Separations & Purifications In-Depth Focus: Experts from Leo Pharma explain how they use an MHC 2D-LC system in their analytical troubleshooting laboratory and how it can be applied to solve key tasks in the lab. Plus, Dave Elder explains how guidance for mutagenic impurities has necessitated control of…
A year on from the Brexit referendum, Dr Penny Owen outlines the potential risks this vote could have on the life science industry and how to prepare for leaving the EU...
