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Innovation in pharma manufacturing quality systems

16 November 2022 | By

Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.

GAMP 5 update: computerized system expectations for pharma manufacturers

16 November 2022 | By , ,

The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…

Putting complex medicines under the microscope

10 November 2022 | By , ,

The biological characterisation of complex medicines like nucleic acid therapeutics and antibody-drug conjugates is important to understand their biodistribution and cellular delivery. Here, Isabel Peset, Lorna FitzPatrick and Martin Main from Medicines Discovery Catapult discuss the potential for using advanced light microscopy techniques.

Solving the taxing problems of taxanes?

4 November 2022 | By

Could the new wave of taxane chemotherapies succeed where traditional chemotherapies have failed? Colin Freund, Chief Executive Officer of Modra Pharmaceuticals, reveals the benefits of this emerging generation of anticancer treatment.

Drug Formulation In-Depth Focus 2022

27 October 2022 | By

Articles in this drug formulation In-Depth Focus explore the design of formulations using cyclodextrins, plus the development of orally-delivered taxane chemotherapies. 

Guide to Outsourcing & Testing

26 October 2022 | By

In this Guide to Outsourcing & Testing, EPR explores trends in the pharmaceutical outsourcing market. Plus, Charles River discusses solutions for tracking, trending and microbial identification and Associates of Cape Cod International showcases its endotoxin testing capabilities.

Using design of experiments to optimise SEC method conditions for proteins

24 October 2022 | By

Size exclusion chromatography (SEC) is routinely used in the pharmaceutical industry to characterise the higher and lower molecular weight species proteins. Here, Gregory Webster, Senior Principal Research Scientist in Analytical Research and Development at AbbVie, explores the challenges, opportunities and optimisations needed to execute design of experiment studies to project…

Pharma’s green mission: trends in bacterial endotoxin testing

21 October 2022 | By , , , ,

Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.