Expert Forums
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...
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14
Join our experts, and by attending this forum, you will: Benefit from in-depth knowledge sharing and insightful discussions for a deeper understanding of ICH Q2(R2) Learn about the shifting regulatory landscape on analytical procedures and the benefits of implementing...
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Webinars
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)....
Using LIMS to solve key laboratory challenges
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)....
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity
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)....
Translating small-molecule development to complex generics and biosimilars
An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics
Understanding the Differences Between Small-Molecule Drugs and Biotherapeutics: An Overview
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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...
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...
A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development
AdvertisementIntroduction Practical, stepwise implementation of ICH Q14 using AQbD tools Full method lifecycle approach: from Analytical Target Profile (ATP) and technology selection to control strategy and lifecycle management Efficient application of Design of...
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...
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
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...
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...
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