Analytical Development & Quality Control (QC) Archives - Page 4 of 7 - BioQC

Analytical Development & Quality Control (QC)

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ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

Panel Q&A | PDF download | Explore how multivariate optimisation tools such as risk assessment, Design of Experiments, and MODR studies can be applied modularly to strengthen method development and inform validation, without replacing fundamental analytical understanding.

Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

by BioQC Summary

Panel Q&A | PDF download | Learn how and when ATPs can be appropriately revised during method development, and explore the bidirectional review process needed to ensure any changes remain scientifically justified and aligned with the overall control strategy.

Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development

by BioQC Expert Forum

On-demand Presentation | Gain a comprehensive overview of ICH Q14 and understand the shifting regulatory landscape around analytical procedure development, including the balance between enhanced risk-based approaches and existing industry practices.

Qualification of Host Cell Protein ELISA and Phase-specific HCP Strategy

by BioQC and Cygnus Technologies Webinar

28 October 2026 | With expert from Cygnus Technologies | Better understand the advantages and limitations of Host Cell Protein (HCP) ELISA.

Improvement of Peak Integration in Capillary Electrophoresis: Reference Data Set No. 1

by BioQC Video Article

Marlon Krompholz | Explore the variability of manual peak integration and discover evidence-based strategies to improve analytical reproducibility.

A Comprehensive Evaluation of Analytical Method Parameters Critical to the Reliable Assessment of Therapeutic mRNA Integrity by Capillary Gel Electrophoresis

by BioQC Video Article

Meet the Expert: Dr. Huixin Lu | Understand how key method parameters, including denaturant type, LNP disruption strategy, and sample preparation, critically influence mRNA integrity results measured by CGE-LIF.

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

by BioQC Article

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.

Summary

Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices

BioQC Panel Q&A | PDF download | Learn how and when ATPs can be appropriately revised during method development, and explore the bidirectional review process needed to ensure any changes remain scientifically justified and aligned with the overall control strategy.

Webinar

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

BioQC 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.

Webinar

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

BioQC 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.

Webinar

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

BioQC 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.

Webinar

ICH Q14 Analytical Procedure Development

BioQC 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.

Expert Forum

Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development

BioQC On-demand Presentation | Gain a comprehensive overview of ICH Q14 and understand the shifting regulatory landscape around analytical procedure development, including the balance between enhanced risk-based approaches and existing industry practices.

Article

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