INSIGHTS ON QUALITY CONTROL

• Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

  Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

• Water Activity: A Better Approach For Lyo Moisture Determination

  Explore why residual moisture content is crucial for freeze-dried pharmaceuticals and how water activity measurement can enhance product safety and stability with innovative laser-based methods.

• The Pain Of Change – Could Suppliers Be Part Of The Cure?

  Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.

• Compressed Gas Risk Assessment: A Significant Step In Your CCS

  Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

• Strategic CMC Planning Through A Phase-Appropriate Quality Approach

  5/28/2024

  A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.

• Antibody-Drug Conjugates – Catalysts For Chemistry

  5/16/2024

  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.

• Optimizing Contamination Control: Strategy Planning And Execution

  7/25/2025

  A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.

• Digitalizing Pharma Control Strategies: A Roadmap

  1/24/2025

  Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

• Experience The Future Of Bioseparations

  4/16/2024

  Learn about an HPLC System designed to improve outcomes in QC labs with ease of use and simplicity at its core.