BioQC Articles | Latest Insights in Biopharmaceutical Quality

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development

AdvertisementIntroduction Practical, stepwise implementation of ICH Q14 using AQbD tools Full method lifecycle approach: from Analytical Target Profile (ATP) and technology selection to control strategy and lifecycle management Efficient application of Design of...

Meet the Expert: Dr. Ewoud van Tricht | Discover how capillary electrophoresis, developed using Design of Experiments, can replace slower techniques like qPCR for adenovirus quantification, cutting analysis time from days to under an hour.

Analytical Method Comparability Studies: Expert Panel Discussion on Instrument and Technology Changes

by BioQC Summary

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists' time and expertise. This expert panel discussion explores practical approaches to comparability studies of analytical methods when...

Expert Insight & Answers | Understand the practical distinctions between comparability, equivalence, and equality in the context of analytical method transitions, and learn how to frame study objectives and acceptance criteria accordingly.

Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health

by BioQC Article

AdvertisementIn the pharmaceutical industry, the stakes for producing high-quality products are unparalleled. Medicines, whether traditional small molecules or advanced biologics, can save lives, prevent diseases, and improve quality of life. However, rigorous Quality...

Industry Primer | Understand why rigorous quality control is essential across the pharmaceutical product lifecycle, and explore how QC approaches differ between small molecules, biologics, and advanced therapies such as cell and gene treatments.

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2 Practical Implementation

by BioQC Summary

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists' time and expertise. This expert panel discussion addresses practical aspects of implementing ICH Q2 Revision 2. Risk Assessment in Method...

Expert Insight & Answers | Gain clarity on the distinction between instrument response linearity and whole-procedure linearity, and explore how adopting response function terminology can improve consistency and reduce confusion across different calibration model types.

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2

by BioQC Summary

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists' time and expertise. This expert panel discussion explores the evolution of analytical method validation under ICH Q2 Revision 2. Evolution from...

Expert Insight & Answers | Explore how prior knowledge and development phase data can be leveraged within a validation framework, and learn what justification is required to implement this lifecycle approach effectively across your organisation.

Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

by BioQC Summary

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists for their time and expertise. This panel focuses on practical aspects of specification setting for biopharmaceuticals under ICH Q6B. Who Sets...

Expert Insight & Answers | Understand how specification setting for biopharmaceuticals requires multidisciplinary input, and learn how release and shelf life specifications are determined and differentiated based on product stability data and process capability.

Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

by BioQC Summary

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists for their time and expertise. Developing analytical methods for biopharmaceuticals requires far more than selecting an instrument and running an...

Expert Insight & Answers | Learn how and when ATPs can be appropriately revised during method development, and explore the bidirectional review process needed to ensure any changes remain scientifically justified and aligned with the overall control strategy.

ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

by BioQC Summary

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists for their time and expertise. An expert panel featuring industry leaders and academics gathered to discuss practical implementation of the ICH...

Expert Insight & Answers | Explore how multivariate optimisation tools such as risk assessment, Design of Experiments, and MODR studies can be applied modularly to strengthen method development and inform validation, without replacing fundamental analytical understanding.