Webinars
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...
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....
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...
Regulatory expectations for your HCP analysis: meet USP <1132.1> to enhance the quality of MS-based data
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)....
Learn how LIMS functions as a workflow system within the laboratory
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)....
The Role of LIMS in Integrated Manufacturing Environments
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Expert Forums
Recent Advances in Process Analytical Technology (PAT) for Downstream 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,...
Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing
Join our experts, and by attending this forum, you will: Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing Understand the practice surrounding post-approval method changes and its impact on...
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Articles
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...
Separation of virus-like particles and nano-emulsions for vaccine development by Capillary Zone Electrophoresis
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...
A Comprehensive Evaluation of Analytical Method Parameters Critical to the Reliable Assessment of Therapeutic mRNA Integrity by Capillary Gel Electrophoresis
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...
ICH Q14: Guideline Overview for Analytical Procedure Lifecycle Management
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...
Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health
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...
Join the conversation (or start a discussion) on the BioQC user community
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Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices
AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists for their time and expertise. This panel focuses on practical aspects of specification setting for biopharmaceuticals under ICH Q6B. Who Sets...
Analytical Target Profiles and Method Development in ICH Q14: A Panel Discussion on Best Practices
AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists for their time and expertise. Developing analytical methods for biopharmaceuticals requires far more than selecting an instrument and running an...
ICH Q14 Implementation: Expert Panel Discussion on Analytical Method Development
AdvertisementThis summary accompanies a recent expert forum discussion organised by BioQC, and we appreciate the panellists for their time and expertise. An expert panel featuring industry leaders and academics gathered to discuss practical implementation of the ICH...
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