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Webinars

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

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

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Event Overview This presentation showcases advanced ELISA-MS™ as the premier technology for detailed characterisation and comprehensive coverage of Host Cell Protein (HCP) ELISA reagents. Precisely assessing HCP coverage is essential for biopharmaceutical development...

28 October 2026 | With expert from Cygnus Technologies | Better understand the advantages and limitations of Host Cell Protein (HCP) ELISA.
Advanced ELISA-MS™ for Host Cell Protein (HCP) coverage and ELISA Antibody Characterisation

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

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Event Overview This presentation showcases advanced ELISA-MS™ as the premier technology for detailed characterisation and comprehensive coverage of Host Cell Protein (HCP) ELISA reagents. Precisely assessing HCP coverage is essential for biopharmaceutical development...

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

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

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Join our experts, and by attending this webinar, you will: Gain a clearer understanding of the updates in ICH Q2 (R2) and Q14, as well as the primary challenges these guidelines pose throughout the analytical lifecycle. Explore opportunities to leverage the improved...

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.
Moving HCP LC-MS analysis into a GMP environment

Moving HCP LC-MS analysis into a GMP environment

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Event Overview Some products, such as advanced therapies and vaccines, are too complex to produce suitable antigens for generating ELISA antibodies for HCP analysis. Moreover, developing process-specific ELISA assays can be very time-consuming and costly....

On-Demand Presentation | Learn directly from Alphalyse's CEO | Understand the basic requirements for implementing a GMP-compliant LC-MS method for host cell protein analysis, including key considerations for alignment with USP 1132.1 and ICH guidelines.
Platform Analytical Procedures, beyond the technical challenges

Platform Analytical Procedures, beyond the technical challenges

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Join our experts, and by attending this webinar, you will: Gain a clearer understanding of the updates in ICH Q2 (R2) and Q14, as well as the primary challenges these guidelines pose throughout the analytical lifecycle. Explore opportunities to leverage the improved...

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.
Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data

Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data

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Event Overview USP 1132.1 is a newly introduced chapter by the United States Pharmacopeia, effective from May 1, 2025. It outlines best practices for measuring residual host cell proteins (HCPs) in biologics using liquid chromatography–mass spectrometry (LC-MS/MS)....

On-Demand Presentation | Incl. panellist from U.S. Pharmacopeia (USP) | Compare the pros and cons of the three HCP quantification methods outlined in USP 1132.1, and gain insight into how LC-MS/MS enables more specific identification and quantification of individual HCPs beyond what traditional ELISA approaches can provide.

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Expert Forums

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Beyond GMP: Selecting and Managing CDMOs for Biological Products

Beyond GMP: Selecting and Managing CDMOs for Biological Products

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Join our experts, and by attending this forum, you will: Gain an understanding of how process analytical technology (PAT) contributes to downstream process development. Learn about the connection between modelling and process analytical technology in downstream...

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

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

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Join our experts, and by attending this forum, you will: Gain an understanding of how process analytical technology (PAT) contributes to downstream process development. Learn about the connection between modelling and process analytical technology in downstream...

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
LIMS as Part of the Manufacturing Application Landscape

LIMS as Part of the Manufacturing Application Landscape

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Event Overview Laboratory Information Management Systems (LIMS) have advanced significantly beyond basic sample tracking. In modern pharmaceutical and biotech settings, LIMS must not only maintain data integrity but also serve as the core of laboratory automation and...

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

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

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Event Overview Laboratory Information Management Systems (LIMS) have advanced significantly beyond basic sample tracking. In modern pharmaceutical and biotech settings, LIMS must not only maintain data integrity but also serve as the core of laboratory automation and...

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.
CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics

CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics

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Join our experts, and by attending this forum, you will: Enhance your understanding of the role of CMC (Chemistry, Manufacturing and Control) in drug development and quality assurance. Gain further insights into how to leverage developmental experience in...

On-demand Presentation | Understand the key differences in CMC processes, quality attributes, and testing methods between small-molecule drugs and biotherapeutics, including contrasts in manufacturing, purification, and regulatory expectations.
Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics

Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics

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Join our experts, and by attending this forum, you will: Enhance your comprehension of the fundamental differences between small-molecule drugs and biologics, including monoclonal antibodies (mAbs) and various novel drug modalities. Recognise the testing requirements,...

On-Demand Presentation | Explore how quality control principles and analytical characterisation strategies evolve across drug modalities and learn what does and does not translate when moving between small-molecule and biological drug development.

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Learning Hubs

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ICH Q14 Guidelines: Fundamentals of Analytical Procedure Development

ICH Q14 Guidelines: Fundamentals of Analytical Procedure Development

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Join our experts, and by attending this forum, you will: Gain an understanding of how process analytical technology (PAT) contributes to downstream process development. Learn about the connection between modelling and process analytical technology in downstream...

Guidelines & Compliance | Explore our ICH Q14 resource hub on Analytical Target Profiles, enhanced approaches & risk-based analytical procedure lifecycle management
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Articles

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

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

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AdvertisementIntroduction Capillary electrophoresis (CE) offers superior separation for complex biologics like monoclonal antibodies, but its irregular baselines and broad, asymmetric peaks make peak integration far more challenging than chromatography—especially in...

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

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

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AdvertisementIntroduction Vaccine formulations increasingly incorporate virus-like particles (VLPs) along with nano-emulsion adjuvants to boost immune responses. However, analytically characterising these mixtures is very difficult because both components are...

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

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

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AdvertisementIntroduction Messenger RNA (mRNA)-lipid nanoparticle (LNP) therapies are an innovative biopharmaceutical approach with quickly adaptable production methods. However, evaluating their quality requires specific analytical techniques that consider the unique...

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.
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics

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AdvertisementIntroduction Introduces a universal study design to assess comparability when switching or updating pharmaceutical analytical instruments, ensuring compliance with GMP requirements. Demonstrates the approach with a benchmark study comparing ICE3 and...

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.

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