Webinar Archives - Page 2 of 4 - BioQC

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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.

Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile

by BioQC Webinar

On-Demand Presentation by Prof. Sandra Furlanetto (University of Florence) | Learn how the Analytical Target Profile functions as a forward-looking framework for defining performance criteria under ICH Q14, and understand how AQbD shifts method development from trial-and-error to a rational, knowledge-driven process applicable to both small molecules and biopharmaceuticals.

Analytical Quality by Design: Critical Analytical Procedure Parameters and Risk Assessments

by BioQC Webinar

On-Demand Presentation by Dr. Cyrille Chéry (UCB) | Discover how prior knowledge can be formally integrated into the risk assessment process to reduce redundant effort across projects, and explore how risk scoring and mitigation planning guide development decisions, including when targeted experiments are needed to validate a parameter's assigned risk level.

Analytical Quality by Design: Analytical Procedure Control Strategy (ACPS)

by BioQC Webinar

On-Demand Presentation by Dr. Lars Geurink (Batavia Biosciences) | Understand what the Analytical Procedure Control Strategy is under ICH Q14, how it connects every stage of method development into a coherent control framework…Understand what the Analytical Procedure Control Strategy is under ICH Q14, how it connects every stage of method development into a coherent control framework, and why "fit for purpose" is the correct standard for evaluating analytical procedures.

ICH Q14 Analytical Procedure Development

by BioQC Webinar

On-Demand Presentation by Dr. Christof Finkler (F. Hoffmann-La Roche AG) | Understand the objectives and development history of ICH Q14, and learn how the minimal and enhanced approaches form a spectrum of increasing procedural understanding, lifecycle flexibility, and more suitably justified established conditions.

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

by BioQC and Alphalyse Webinar

On-Demand Presentation | 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.

The Role of LIMS in Integrated Manufacturing Environments

by BioQC and LabWare Webinar

On-Demand Presentation by Jon Walker, LabWare | Explore what a well-designed LIMS ecosystem looks like in practice, and gain a realistic perspective on the current limitations and future potential of AI and machine learning tools within laboratory informatics environments.

Using LIMS to solve key laboratory challenges

by BioQC and LabWare Webinar

On-Demand Presentation by Melanie Clark, LabWare | Understand how LIMS establishes end-to-end sample traceability, enforces ALCOA+ principles, and addresses regulatory compliance gaps through audit trails, electronic signatures, and automated out-of-specification alerts.

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.

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.

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.

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.

Webinar

Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles

BioQC On-Demand Presentation by Dr. Francisca Galindo Garre (Johnson & Johnson Innovative Medicine) | Compare qPCR and capillary electrophoresis head-to-head and gain the statistical toolkit, from equivalence testing to correlated variance regression, to make defensible method interchangeability decisions.

Webinar

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

BioQC On-Demand Presentation by Dr. Anne Ries (Boehringer Ingelheim) | Discover how historical QC control chart data can replace prospective experiments on the old instrument to set statistically robust acceptance criteria, illustrated through a real-world icIEF platform transition across multiple commercial products.

Webinar

Beyond Accuracy and Precision: Total Analytical Error and Linearity in ICH Q2 Revision 2

BioQC On-Demand Presentation by Dr. Pierre Lebrun (Cencora – PharmaLex) | Discover how an integrated validation experiment design can simultaneously address linearity, bias, and intermediate precision across the operational range, linking directly to the Analytical Target Profile and product specifications without increasing experimental burden.

Webinar

From ATP to Acceptance Criteria: Mastering ICH Q2 Revision 2

BioQC 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.

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.

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