Expert Forums
LIMS as Part of the Manufacturing Application Landscape
LIMS as Part of the Manufacturing Application LandscapeEvent 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...
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data Integrity
Beyond Sample Tracking – LIMS as the Backbone of Laboratory Data IntegrityEvent Overview Laboratory Information Management Systems (LIMS) have advanced significantly beyond basic sample tracking. In modern pharmaceutical and biotech settings, LIMS must not only...
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 BiotherapeuticsJoin 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...
Understanding The Difference Between Small-Molecule Drugs And Biotherapeutics
Understanding The Difference Between Small-Molecule Drugs And BiotherapeuticsJoin 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...
Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing
Best Practices for Updating Analytical Procedures in Drug Development and ManufacturingJoin our experts, and by attending this forum, you will: Learn the regulatory expectations for replacing or updating analytical procedures during drug development and manufacturing...
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14Join 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)...
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Webinars
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
Synthetic-Biologics Fusion Cuisine: Innovation in Analytical Characterisation of Novel Drug Modalities
Capillary Electrophoresis (CE) versus quantitative Polymerase Chain Reaction (qPCR) for direct quantification of intact adenovirus particles
Universal Study Design for Instrument Changes in Pharmaceutical Release Analytics
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Articles
Meet the Expert: Ewoud van Tricht on 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...
Meet the Expert: Anne Ries on 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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