INSIGHTS ON QUALITY CONTROL

• Modernizing Compendial SEC Methods For Biotherapeutics

  Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.

• Antibody-Drug Conjugates – Catalysts For Chemistry

  Review the complexities of developing linkers – chemical moieties which attach a drug payload to an antibody – and considerations when identifying a CRO for ADC research and development.

• Integration Of Container Closure Integrity In Contract Manufacturing

  Maintaining drug product sterility and compliance demands rigorous Container Closure Integrity (CCI) within contract manufacturing. Learn how to fortify your processes.

• HPLC Autosampler Performance I: Challenging USP Methods

  In this study, the injection precision of an Alliance iS HPLC System was evaluated using four compendial HPLC methods from the USP with challenging method conditions and strict system suitability criteria.

• A Closer Look At Multi-Lane Checkweighing In Pharma

  5/2/2025

  Learn how multi-lane checkweighing boosts operational efficiency, ensures accurate dosing, and simplifies changeovers, making it ideal for applications like dual-chamber sachets and nutraceutical products.

• Nitrosamine Impurities Deadline: Are Your Products Compliant?

  12/5/2023

  Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.

• Improved GLP-1 Receptor Agonist Peptide Recovery

  6/30/2025

  Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.

• Effect Of X-Ray Inspection On Pharmaceutical Products

  7/23/2024

  Explore the use of X-ray inspection systems for the internal examination of pharmaceutical products, particularly non-transparent packaged drugs.

• Mitigating CMC Issues Using A Holistic Approach To Developability Assessment

  3/27/2025

  Comprehensive chemistry, manufacturing, and control (CMC) developability testing is essential to mitigate the risk of costly late-stage failures and to proactively address potential challenges.