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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
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
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.
Translating small-molecule development to complex generics and biosimilars
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.
Synthetic-Biologics Fusion Cuisine: Innovation in Analytical Characterisation of Novel Drug Modalities
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.
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.
An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics
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
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.
Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health
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.
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