Chemistry, Manufacturing, and Controls (CMC) Archives - BioQC

Chemistry, Manufacturing, and Controls (CMC)

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A Prospective ICH Q2(R2) Validation of Untargeted Proteomics for Host Cell Protein Quantification

by BioQC Webinar

23 September 2026 | GSK's Dr. Somar Khalil | This presentation describes the first validation of a label-free, untargeted proteomics method that meets ICH Q2(R2) expectations.

Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics

by BioQC Article

Read Article Review | Access full paper | A regulatory-oriented framework that enables advanced LC-MS/MS proteomics workflows to move closer to routine biopharmaceutical quality control.

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.

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.

ICH Q14 Guidelines: Fundamentals of Analytical Procedure Development

by BioQC Learning Hub

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.

Meet the Expert: Method Validation in Pharmaceutical Analysis

by BioQC Video Article

Watch Author Insights | Expert: Dr. Joachim Ermer | Move beyond checkbox compliance and master the full analytical lifecycle, from method design to routine verification, with purpose-driven validation grounded in ICH Q2 and Q14.

Synthetic-Biologics Fusion Cuisine: Innovation in Analytical Characterisation of Novel Drug Modalities

by BioQC Webinar

On-Demand Presentation by Dr. Bingchuan Wei, MBA (Genentech) | Understand why novel drug modalities such as ADCs and oral biologics require hybrid development and control strategies that draw on both small molecule and biologic frameworks, and explore how release testing and quality attributes are adapted accordingly.

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

by BioQC Article

Read Industry Primer | Full text | 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.

Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices

by BioQC Summary

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

A Prospective ICH Q2(R2) Validation of Untargeted Proteomics for Host Cell Protein Quantification

BioQC 23 September 2026 | GSK's Dr. Somar Khalil | This presentation describes the first validation of a label-free, untargeted proteomics method that meets ICH Q2(R2) expectations.

Video Article

Meet the Expert: Method Validation in Pharmaceutical Analysis

BioQC Watch Author Insights | Expert: Dr. Joachim Ermer | Move beyond checkbox compliance and master the full analytical lifecycle, from method design to routine verification, with purpose-driven validation grounded in ICH Q2 and Q14.

Article

Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics

BioQC Read Article Review | Access full paper | A regulatory-oriented framework that enables advanced LC-MS/MS proteomics workflows to move closer to routine biopharmaceutical quality control.

Webinar

Translating small-molecule development to complex generics and biosimilars

BioQC 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.

Webinar

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

BioQC 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.

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.

Webinar

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

BioQC 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.

Webinar

Synthetic-Biologics Fusion Cuisine: Innovation in Analytical Characterisation of Novel Drug Modalities

BioQC On-Demand Presentation by Dr. Bingchuan Wei, MBA (Genentech) | Understand why novel drug modalities such as ADCs and oral biologics require hybrid development and control strategies that draw on both small molecule and biologic frameworks, and explore how release testing and quality attributes are adapted accordingly.

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

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

BioQC Read Industry Primer | Full text | 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.

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