Webinars
A Prospective ICH Q2(R2) Validation of Untargeted Proteomics for Host Cell Protein Quantification
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...
Qualification of Host Cell Protein ELISA and Phase-specific HCP Strategy
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...
The Use of Capillary Electrophoresis in Cell and Gene Therapy and Vaccine Development
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...
Advanced ELISA-MS™ for Host Cell Protein (HCP) coverage and ELISA Antibody Characterisation
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...
Platform Analytical Procedures, beyond the technical challenges
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...
Moving HCP LC-MS analysis into a GMP environment
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....
Opportunities and challenges from ICH Q2 (2) and Q14 for the analytical lifecycle
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...
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Expert Forums
Beyond GMP: Selecting and Managing CDMOs for Biological Products
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...
Recent Advances in Process Analytical Technology (PAT) for Downstream and Upstream Processing
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...
LIMS as Part of the Manufacturing Application Landscape
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...
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity
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...
CMC: A Developmental Approach to Ensure Drug Quality – from Small-Molecule Drugs to Biotherapeutics
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...
Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics
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,...
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Learning Hubs
ICH Q14 Guidelines: Fundamentals of Analytical Procedure Development
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...
Articles
Improvement of Peak Integration in Capillary Electrophoresis: Reference Data Set No. 1
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...
Rapid Platform icIEF Methods Development with AESlyte® HR 5–10.5 for Diverse mAbs
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...
Expert Panel Discussion on Platform Analytical Procedures, beyond the technical challenges
Advertisement This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their...
Peak Integration of Electropherograms in GMP and Research Labs: Navigating Increased Scrutiny Amid Data Integrity Audits and Inspections
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...
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