BioQC and Alphalyse, Author at BioQC

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From ATP to Acceptance Criteria: Mastering ICH Q2 Revision 2

On-Demand Presentation by Dr. Joachim Ermer (Ermer Quality Consulting) | Learn how to derive defensible ATP acceptance criteria directly from manufacturing and analytical performance requirements, using probability-based approaches to set specification-linked precision and accuracy limits rather than relying solely on empirical expectations.

Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14

by BioQC Expert Forum

On-Demand Presentation | Gain practical guidance on adapting validation practices for biotechnological analytical methods, including cell-based assays and platform technologies, and explore strategies for addressing common gaps in regulatory filing packages.

Pierre Lebrun

by BioQC

Joachim Ermer

by BioQC

Patient-Centric Specification Setting: Beyond Batch Data

by BioQC Webinar

On-Demand Presentation by Dr. Simona Cianetti (GSK) | Understand the principles of patient-centric specification setting and learn how clinical exposure data, process characterisation, and modelling can be combined to establish clinically justified acceptance criteria that go beyond batch data and manufacturing variability.

Statistically Sound Specification Setting – A Practical Approach Consistent with ICH Q6B and Q14

by BioQC Webinar

On-Demand Presentation by Dr Eric Rozet (GSK) | Discover how Design of Experiments, statistical process control, and stability modelling contribute to a comprehensive, statistically grounded specification-setting framework aligned with ICH Q6B and Q14, and explore how Bayesian methods can incorporate prior process knowledge to strengthen this approach.

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Regulatory science behind drug substance & drug product specifications of monoclonal antibodies

by BioQC Webinar

On-Demand Presentation by Dr. Patanachai “Kong” Limpikirati (Chulalongkorn University) | Learn how to construct a comprehensive specification framework for monoclonal antibodies under ICH Q6B, covering the five core quality attribute categories and understanding which tests belong in drug substance versus drug product specifications.

Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B

by BioQC Expert Forum

On-demand Presentation | Gain an overview of ICH Q6B and current practices for setting specifications for biopharmaceuticals, including monoclonal antibodies and advanced therapies, and understand the statistical and analytical considerations involved.

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

by BioQC Summary

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.

Webinar

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

BioQC and Alphalyse 17 June 2026 | 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.

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Moving HCP LC-MS analysis into a GMP environment

BioQC and Alphalyse On-Demand Presentation | Learn directly from Alphalyse's CEO | Understand the basic requirements for implementing a GMP-compliant LC-MS method for host cell protein analysis, including key considerations for alignment with USP 1132.1 and ICH guidelines.

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Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data

BioQC and Alphalyse On-Demand Presentation | Incl. panellist from U.S. Pharmacopeia (USP) | Compare the pros and cons of the three HCP quantification methods outlined in USP 1132.1, and gain insight into how LC-MS/MS enables more specific identification and quantification of individual HCPs beyond what traditional ELISA approaches can provide.

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From ATP to Acceptance Criteria: Mastering ICH Q2 Revision 2

Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14

Pierre Lebrun

Joachim Ermer

Patient-Centric Specification Setting: Beyond Batch Data

Statistically Sound Specification Setting – A Practical Approach Consistent with ICH Q6B and Q14

bioqc-light

Regulatory science behind drug substance & drug product specifications of monoclonal antibodies

Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B

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

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

Moving HCP LC-MS analysis into a GMP environment

Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data

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