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Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

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.

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.

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.

Summary

Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

BioQC 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.

Webinar

Patient-Centric Specification Setting: Beyond Batch Data

BioQC 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.

Webinar

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

BioQC 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.

Webinar

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

BioQC 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.

Expert Forum

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

BioQC 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.

Advertisement

Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

Patient-Centric Specification Setting: Beyond Batch Data

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

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

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

Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

Patient-Centric Specification Setting: Beyond Batch Data

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

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

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

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