Chemistry, Manufacturing, and Controls (CMC) Archives - Page 2 of 3 - BioQC

Chemistry, Manufacturing, and Controls (CMC)

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

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.

Translating small-molecule development to complex generics and biosimilars

by BioQC Webinar

On-Demand Presentation by Dr. Joseph Glajch (JLG AP Consulting) | Explore the concept of fingerprint-like similarity in biosimilar development aand discover how orthogonal analytical methods applied across large reference product datasets can reduce residual uncertainty and influence the scope of clinical testing required.

An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics

by BioQC Webinar

On-Demand Presentation by by Dr Michael Dong (MWD Consulting) | Examine how quality attributes and QC testing methods differ between small molecules and biologics, and understand where small-molecule CMC experience translates meaningfully to biotherapeutics and where fundamental differences require a distinct approach.

An Overview of Key Differences of Small-Molecule Drugs and Biotherapeutics: Perspectives and Quality Attributes

by BioQC Webinar

On-Demand Presentation by Dr. Michael Dong (MWD Consulting) | Explore a practical case study comparing Tarceva and Herceptin to illustrate how differences in drug substance, manufacturing, and commercial lifecycle play out in real development programmes.

Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics

by BioQC Expert Forum

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.

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

by BioQC Expert Forum

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.

Summary

Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

BioQC Panel Q&A | PDF download | 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

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.

Learning Hub

ICH Q14 Guidelines: Fundamentals of Analytical Procedure Development

BioQC Stay ahead on guidelines | Curated Educational Resources | Learn the difference between minimal and enhanced approaches to analytical procedure development, and how implementing more elements of the enhanced approach fosters deeper procedural understanding.

Article

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