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Advanced ELISA-MS™ for Host Cell Protein (HCP) coverage and ELISA Antibody Characterisation

On-Demand Presentation | With experts from Alphalyse | Learn about the pros and cons of HCP ELISA coverage methods outlined in USP 1132 and 1132.1, and understand how ELISA-MS™ combines immunocapture with LC-MS to provide more accurate and specific antibody characterisation than traditional approaches.

Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

by BioQC Expert Forum

9 December 2026 | PAT implementation, effects on yield, consistency, and scalability, and the roles of modelling and chemometrics in facilitating advanced monitoring and control strategies

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Expert Forum

CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics

BioQC On-demand Presentation | Understand the key differences in CMC processes, quality attributes, and testing methods between small-molecule drugs and biotherapeutics, including contrasts in manufacturing, purification, and regulatory expectations.

Expert Forum

Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics

BioQC On-Demand Presentation | Explore how quality control principles and analytical characterisation strategies evolve across drug modalities and learn what does and does not translate when moving between small-molecule and biological drug development.

Article

ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

BioQC Gain Valuable Regulatory Insights | Obtain a clear overview of the ICH Q14 guideline and understand how its lifecycle management framework integrates method development, validation, and continual improvement into a cohesive, science-based approach.

Video Article

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

BioQC 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.

Summary

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

BioQC 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.

Webinar

Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles

BioQC On-Demand Presentation by Dr. Francisca Galindo Garre (Johnson & Johnson Innovative Medicine) | Compare qPCR and capillary electrophoresis head-to-head and gain the statistical toolkit, from equivalence testing to correlated variance regression, to make defensible method interchangeability decisions.

Webinar

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

BioQC On-Demand Presentation by Dr. Anne Ries (Boehringer Ingelheim) | Discover how historical QC control chart data can replace prospective experiments on the old instrument to set statistically robust acceptance criteria, illustrated through a real-world icIEF platform transition across multiple commercial products.

Expert Forum

Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing

BioQC On-Demand Presentation | Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing Understand the practice surrounding post-approval method changes and its impact on compliance Identify when pharmacopoeial methods are necessary and when alternative validated methods may be used Gain practical insights into testing comparability between methods and replacing existing methods or instrumentation

Article

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

BioQC 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.

Summary

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

BioQC 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.

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