Manufacturing Classification System (MCS)
Here, David Elder elucidates the workings of the manufacturing classification system (MCS) used to guide decision making for drug formulators.
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Articles
The future of vaccine research and learning the lessons of COVID-19
Dr Owen Seddon, Consultant in Infectious Diseases and Medical Microbiology at University Hospital of Wales, explains how successes in the development of the coronavirus vaccine must be used in the fight against other vaccine preventable disease.
Ensuring consistency and stability in antibody therapies
Disulphide bonds between cysteines play a critical role in the stability and activity of therapeutic antibodies. Here, Dr Ioannis Papayannopoulos, Principal Scientist at Dragonfly Therapeutics, describes the characterisation of the oxidation state of cysteines and formed disulphides in therapeutic antibody drugs.
Analysis of illicit drugs and wastewater-based epidemiology: current methodological techniques
Ayman AlSaadi and Wayne G Carter from the School of Medicine, University of Nottingham, illustrate the value of analysing the wastewater of specific populations to gain insight into levels of illegal drug usage and other health-related biomarkers.
Precision medicine for complex chronic diseases: how near are we?
Targeting medicines against the genetic and molecular drivers of lung, breast and other tumours has helped transform cancer care for many patients, yet precision medicine for complex chronic diseases has lagged behind. Maria Orr, Adam Platt and Ben Challis, from BioPharmaceuticals R&D at AstraZeneca, explain why this is changing for…
The future of CMC for novel therapies
Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal…
Essential requirements for autologous cellular therapies
Edward Samuel, EVP Technical Operations at Achilles Therapeutics, explains why industrialised manufacturing and scale-up of autologous cellular immunotherapies will require fully closed systems and process automation.
Engaging the innate immune system to fight cancer effectively
Most therapeutic approaches in immuno-oncology focus on targeting the adaptive immune system; innate immunity has only recently gathered momentum. One of the most potent receptors for activating innate immune cells such as natural killer cells and macrophages is CD16A. Addressing this target mimics the body’s natural defense against potential threats,…
Setting a new standard of care for liver MRI contrast agents in patients with reduced kidney function
A ‘hot’ topic on the radar of radiologists in recent years has been the safety of the potentially toxic gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). This is especially pertinent in the detection of focal liver lesions for patients with poor kidney function due to potentially fatal…
Quality-driven solutions from discovery to commercialisation
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
Guide to Testing
Welcome to European Pharmaceutical Review’s Guide to Testing. In this edition, Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, discusses the benefits of leveraging acoustic emission testing to identify faults in compressed air pressure vessels, and Associates of Cape Cod and SGS Health Science showcase their services,…
Bioprocessing/Bioproduction In-Depth Focus 2022
Download this in-depth focus to discover why closed systems and process automation are key for industrialised autologous cell therapy manufacturing and how CMC strategies for cell and gene therapies need to evolve.
Drug Formulation In-Depth Focus 2022
Features in this in-depth focus highlight developments in the MRI contrast agent space, explore the development of precision medicine for chronic diseases and explain why immunotherapies should engage the innate immune system in the fight against cancer.
QA/QC Mass Spectrometry/ Chromatography In-Depth Focus 2022
In this in-depth focus, articles illustrate how mass spectrometry‑based wastewater analysis can estimate illicit drug usage and explore the applications of mass spectrometry in characterising therapeutic antibodies.
European Pharmaceutical Review Issue 2 2022
Features in this issue discuss how bioprocessing must adapt to meet the needs of autologous cell therapies, the role of mass spectrometry in enhancing antibody consistency and the economic benefits of embracing continuous manufacturing. Also in this journal, articles exploring the development of precision medicine for chronic diseases, why acoustic…
