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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, 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…
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.
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
