ICH opens consultation on Q3E drug impurities guideline on leachables
Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
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Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
In this article, Amanda Guiraldelli Mahr, Joachim Ermer, Jaime Marach, Phil Borman and other members of USP’s Analytical Procedure Lifecycle Joint Subcommittee explore the latest advancements in ICH Q2(R2) guidelines on validation of analytical procedures and their implications for industry. The authors also identify areas that would benefit from additional guidance and compare…
In this article, Edita Botonjic-Sehic, Head of Process Analytics and Data Science at ReciBioPharm, examines the need for a digitally controlled continuous manufacturing process to correct the shortcomings of the current standard of batch processing. She highlights the critical role in-line process analytic technologies (PAT), automation and real-time data analytics…
The recently updated ICH Q2(R2) guidance marks a significant milestone in analytical procedure validation. Dave Elder explains why.
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
Raquera Brown, Executive Director of Quality at Zymeworks offers quality and compliance professionals advice on how to navigate the often-complex regulatory space during development of innovative drugs like antibody therapeutics.
An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the European Medicines Agency (EMA).
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
The biopharmaceutical industry is driven by the need to increase production and reduce costs, while maintaining product quality – and has increasingly been focused on intensification of processes to accomplish this goal. In this article, European Pharmaceutical Review’s Hannah Balfour summarises the potential benefits of implementing continuous bioprocessing and manufacturing…
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…