Analytical Development & Quality Control (QC) Archives - Page 3 of 7 - BioQC

Analytical Development & Quality Control (QC)

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

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.

Separation of virus-like particles and nano-emulsions for vaccine development by Capillary Zone Electrophoresis

by BioQC Video Article

Meet the Expert: Dr. Adam Sutton | Learn practical strategies for developing and validating a single CZE method capable of simultaneously characterising nanoparticles, surfactants, and small molecules in multi-component pharmaceutical formulations.

Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity

by BioQC Expert Forum

On-Demand Presentation | Understand how LIMS have evolved from basic sample tracking to comprehensive digital data management systems, and learn how they support ALCOA+ compliance, audit-ready traceability, and GxP-compliant laboratory operations.

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

by BioQC Video Article

Meet the Expert: Dr. Anne Ries | Explore a practical benchmark example comparing two icIEF instruments, and gain a reusable framework to support lifecycle management of analytical methods in regulated environments.

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.

ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

by BioQC Article

Gain Valuable Regulatory Insights | Obtain a clear overview of the ICH Q14 guideline and understand how its lifecycle management framework integrates method development, validation, and continual improvement into a cohesive, science-based approach.

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

by BioQC Webinar

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.

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

by BioQC Webinar

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.

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2 Practical Implementation

by BioQC Summary

Panel Q&A | PDF download | Gain clarity on the distinction between instrument response linearity and whole-procedure linearity, and explore how adopting response function terminology can improve consistency and reduce confusion across different calibration model types.

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2

by BioQC Summary

Panel Q&A | PDF download | Explore how prior knowledge and development phase data can be leveraged within a validation framework, and learn what justification is required to implement this lifecycle approach effectively across your organisation.

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.

Expert Forum

Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing

BioQC On-Demand Presentation | Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing Understand the practice surrounding post-approval method changes and its impact on compliance Identify when pharmacopoeial methods are necessary and when alternative validated methods may be used Gain practical insights into testing comparability between methods and replacing existing methods or instrumentation

Article

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

BioQC 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 Method Validation: Expert Panel Discussion on ICH Q2 Revision 2 Practical Implementation

BioQC Panel Q&A | PDF download | Gain clarity on the distinction between instrument response linearity and whole-procedure linearity, and explore how adopting response function terminology can improve consistency and reduce confusion across different calibration model types.

Summary

Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2

BioQC Panel Q&A | PDF download | Explore how prior knowledge and development phase data can be leveraged within a validation framework, and learn what justification is required to implement this lifecycle approach effectively across your organisation.

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.

Expert Forum

Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14

BioQC On-Demand Presentation | Gain practical guidance on adapting validation practices for biotechnological analytical methods, including cell-based assays and platform technologies, and explore strategies for addressing common gaps in regulatory filing packages.

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.

Summary

ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development

BioQC 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.

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