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A Prospective ICH Q2(R2) Validation of Untargeted Proteomics for Host Cell Protein Quantification

A Prospective ICH Q2(R2) Validation of Untargeted Proteomics for Host Cell Protein Quantification

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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...

23 September 2026 | GSK's Dr. Somar Khalil | This presentation describes the first validation of a label-free, untargeted proteomics method that meets ICH Q2(R2) expectations.
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.
The Use of Capillary Electrophoresis in Cell and Gene Therapy and Vaccine Development

The Use of Capillary Electrophoresis in Cell and Gene Therapy and Vaccine Development

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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...

4 November 2026 | Addressing emerging analytical challenges, evolving regulatory expectations, and potential solutions for developing robust, fit-for-purpose CE methods for next-generation CGT and vaccine products.
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.
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.
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.
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.

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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...

Stay ahead on guidelines | Curated Educational Resources | Learn the difference between minimal and enhanced approaches to analytical procedure development, and how implementing more elements of the enhanced approach fosters deeper procedural understanding.

Articles

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

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

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AdvertisementThe AESlyte Rapid Method Development Kit is designed to make developing icIEF methods for monoclonal antibodies and other biotherapeutics quicker and easier. Using AESlyte HR 5–10.5 with two default pI markers (5.72 & 9.71), the standardised workflow...

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

Watch Author Insights | 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.
Comprehensive method development for a wide size range of RNA

Comprehensive method development for a wide size range of RNA

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AdvertisementThe integrity and quality of the encapsulated nucleic acids used in cell and gene therapy are important to ensure the efficacy and safety of the therapeutic product. Current methods used to characterise the integrity and quality of these nucleic acids are...

PDF download | This work introduces a new chemistry and methods optimisation strategy that is applicable to singlestranded RNAs, with lengths ranging from 50 to 9000 bases, to achieve high-resolution and high-quality data.
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...

Watch Author Insights | Merck's 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.

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