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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
Early phase CGT trials: key design elements correlating to distinctive biological characteristics
With increasing numbers of cell and gene therapies (CGTs) entering clinical trials, Dr Dave Li and Dr Anna Baran of KCR Consulting discuss how the biological characteristics of CGTs should be taken into account with early phase trial designs.
Preparation is key: the role of scientific due diligence in successful partnerships
Small biopharma companies often need to partner with larger firms to achieve their goals, but such agreements can fail if preparations are poor. Here, Diane Seimetz and Jörg Schneider at Biopharma Excellence discuss how due diligence smooths the path to collaboration.
Establishing precision medicine in Abu Dhabi
Work is underway to create a collaborative virtual research institute (VRI) to support the fundamental research and subsequent clinical translation of precision medicine in Abu Dhabi, as well as the United Arab Emirates more broadly. Here, European Pharmaceutical Review’s Hannah Balfour discusses the project with the Head of the new…
Pharma’s new healthcare role brings new opportunities
As the face of healthcare changes and the emphasis on more-targeted remedies and preventative care increases, pharma’s traditional role in healthcare must also evolve. Here, Vintura Consultancy’s Gérard Klop looks at how pharma might carve out a new role in a more value-based healthcare market.
The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
Advancing extractables and leachables testing
With comment from Diane Paskiet, chair of the Product Quality Research Institute (PQRI) L&E Working Group, EPR’s Hannah Balfour outlines three key exposure-based safety thresholds and explores how the new extractables and leachables (E&Ls) strategy for parenteral drug products was established.
Can continuous manufacturing add shareholder value for pharmaceutical companies?
A recent empirical study of continuous manufacturing (CM) versus batch processing of US and non‑US pharmaceutical manufacturing facilities suggests that CM would be more economical than batch facilities, at least for the production of oral solid dosage products. This has significant consequences for policies and strategies to reduce supply chain…
Reducing downtime: acoustic emission testing of compressed air pressure vessels in pharmaceutical production
Leakage, cracking and corrosion in pressure vessels present a serious risk for operators of pharmaceutical production systems. Imminent damage must be reliably identified at an early stage to enable necessary steps to be promptly taken. Oliver Großgart, Plant Safety Expert at TÜV SÜD Industrie Service GmbH, explains how TÜV SÜD…
Manufacturing Classification System (MCS)
Here, David Elder elucidates the workings of the manufacturing classification system (MCS) used to guide decision making for drug formulators.
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.
