Join BioQC Insights

Advertisement

Webinars

Browse All Webinars
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

by

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

by

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

by

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...

Learn from GSK experts to identify significant challenges and practical solutions for deploying and maintaining platform analytical procedures throughout different development and lifecycle stages.
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

by

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...

17 June 2026 | 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.
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

by

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 | 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.
LIMS as Part of the Application Landscape for Manufacturing

LIMS as Part of the Application Landscape for Manufacturing

by

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 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.

Advertisement

Expert Forums

Browse All Expert Forums
Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing

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

by

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...

Upcoming | Obtain an overview of common analytes and analytical techniques used as PAT for cell culture/fermentation and purification.
LIMS as Part of the Manufacturing Application Landscape

LIMS as Part of the Manufacturing Application Landscape

by

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

by

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

by

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

by

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.

Advertisement

Articles

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

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

by

AdvertisementIntroduction As biopharmaceuticals grow in complexity, traditional peak integration algorithms are increasingly struggling to keep pace, particularly in Capillary Electrophoresis (CE), where intricate sample profiles expose the limits of conventional...

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

by

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

by

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.
ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management

by

AdvertisementThe ICH Q14 guideline, formally part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), represents a step forward in ensuring that analytical methods for pharmaceuticals are scientifically...

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

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

by

AdvertisementIn the pharmaceutical industry, the stakes for producing high-quality products are unparalleled. Medicines, whether traditional small molecules or advanced biologics, can save lives, prevent diseases, and improve quality of life. However, rigorous Quality...

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

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

by

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists' time and expertise. This expert panel discussion explores practical approaches to comparability studies of analytical methods when...

Expert Insight & Answers | 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.
Analytical Method Validation: Expert Panel Discussion on ICH Q2 Revision 2 Practical Implementation

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

by

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists' time and expertise. This expert panel discussion addresses practical aspects of implementing ICH Q2 Revision 2. Risk Assessment in Method...

Expert Insight & Answers | 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

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

by

AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists' time and expertise. This expert panel discussion explores the evolution of analytical method validation under ICH Q2 Revision 2. Evolution from...

Expert Insight & Answers | 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.

Advertisement