Analytical Development & Quality Control (QC) Archives - Page 2 of 7 - BioQC

Analytical Development & Quality Control (QC)

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Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing

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

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

by BioQC Webinar

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.

From ATP to Acceptance Criteria: Mastering ICH Q2 Revision 2

by BioQC Webinar

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.

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

by BioQC Expert Forum

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.

Statistically Sound Specification Setting – A Practical Approach Consistent with ICH Q6B and Q14

by BioQC Webinar

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.

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.

Rapid Platform icIEF Methods Development with AESlyte HR 5–10.5 for Diverse mAbs

by BioQC and Advanced Electrophoresis Solutions Application Note

PDF download | The AESlyte Rapid Method Development Kit is designed to streamline and accelerate the creation of icIEF methods for mAbs and various biotherapeutics.

Video Article

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

BioQC 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.

Webinar

Explore the key success factors and implementation challenges in LIMS deployment

BioQC On-Demand Presentation by Ramon de Groot (Limes Lab Support) | Understand how modern LIMS enforces ALCOA+ principles and has evolved from basic sample tracking into a central laboratory data management platform integrating with instruments, ELN, and ERP systems.

Expert Forum

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

BioQC 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.

Video Article

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

BioQC 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.

Video Article

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

BioQC 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.

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.

Article

ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

BioQC 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.

Video Article

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development

BioQC Meet the Expert: Dr. Ewoud van Tricht | Discover how capillary electrophoresis, developed using Design of Experiments, can replace slower techniques like qPCR for adenovirus quantification, cutting analysis time from days to under an hour.

Summary

Analytical Method Comparability Studies: Expert Panel Discussion on Instrument and Technology Changes

BioQC Panel Q&A | PDF download | Understand the practical distinctions between comparability, equivalence, and equality in the context of analytical method transitions, and learn how to frame study objectives and acceptance criteria 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.

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