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Meet the Expert: Method Validation in Pharmaceutical Analysis

Meet the expert: Joachim Ermer | Move beyond checkbox compliance and master the full analytical lifecycle, from method design to routine verification, with purpose-driven validation grounded in ICH Q2 and Q14.

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by Lilwen Faulkner

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by Lilwen Faulkner

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.

Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

by BioQC Expert Forum

9 December 2026 | PAT implementation, effects on yield, consistency, and scalability, and the roles of modelling and chemometrics in facilitating advanced monitoring and control strategies

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by Lilwen Faulkner

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by Lilwen Faulkner

Expert Forum

Beyond GMP: Selecting and Managing CDMOs for Biological Products

BioQC 30 September 2026 | Articulate why regulatory compliance is an entry criterion, not a differentiator, and identify the three failure modes that standard audits consistently miss for biological products.

Article

Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics

BioQC Spotlight | A regulatory-oriented framework that enables advanced LC-MS/MS proteomics workflows to move closer to routine biopharmaceutical quality control.

Video Article

Meet the Expert: Method Validation in Pharmaceutical Analysis

BioQC Meet the expert: Joachim Ermer | Move beyond checkbox compliance and master the full analytical lifecycle, from method design to routine verification, with purpose-driven validation grounded in ICH Q2 and Q14.

Expert Forum

Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

BioQC 9 December 2026 | PAT implementation, effects on yield, consistency, and scalability, and the roles of modelling and chemometrics in facilitating advanced monitoring and control strategies

Video Article

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

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

Webinar

Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

BioQC On-Demand Presentation | With experts from GSK | Assess the practical implications of established conditions for lifecycle flexibility and regulatory engagement, and gain a forward-looking perspective on how widespread adoption of these guidelines will shape the future of analytical lifecycle management.

Webinar

Platform Analytical Procedures, beyond the technical challenges

BioQC On-Demand Presentation | Learn from GSK experts to identify significant challenges and practical solutions for deploying and maintaining platform analytical procedures throughout different development and lifecycle stages.

Webinar

LIMS as Part of the Application Landscape for Manufacturing

BioQC On-Demand Presentation by Paul Shrevel (Solution Too) | Understand how LIMS fits within the broader ISA-95 manufacturing application landscape, connecting laboratory workflows to ERP, QMS, and supply chain systems, and recognise the data integrity risks associated with local instrument data storage.

Expert Forum

LIMS as Part of the Manufacturing Application Landscape

BioQC On-Demand Presentation | Understand how modern LIMS function as the central hub of laboratory automation and data integrity, supporting compliance with ALCOA+ principles across development and quality control environments.

Video Article

Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections

BioQC Meet the Expert: Dr. Timothy Blanc | Explore the current lack of regulatory guidance for electropherogram integration and discover how industry-wide harmonisation of guidelines, benchmarks, and software could strengthen analytical reliability.

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Landing pages (17)

Landing pages (4)

Meet the Expert: Method Validation in Pharmaceutical Analysis

New Landing pages (4)

Landing pages (16)

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

Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

Landing pages (14)

Landing pages (15)

Beyond GMP: Selecting and Managing CDMOs for Biological Products

Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics

Meet the Expert: Method Validation in Pharmaceutical Analysis

Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

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

Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle

Platform Analytical Procedures, beyond the technical challenges

LIMS as Part of the Application Landscape for Manufacturing

LIMS as Part of the Manufacturing Application Landscape

Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections

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