INSIGHTS ON QUALITY CONTROL

• Monitoring Microbial Contamination Of Mammalian Cell Cultures

  Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

• Data-Driven Methods for Ensuring Container Closure Integrity

  An integral component to a robust quality control program is container closure integrity testing (CCIT), which helps ensure the prevention of contamination and/or the degradation of a product.

• EMPQ And Validation Support Services

  A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

• Nitrosamine Impurities Deadline: Are Your Products Compliant?

  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.

• Vial Breakage During Lyophilization: Root Causes And Mitigation

  10/16/2024

  Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.

• 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.

• Implementing A Risk-Based Approach To Calibration

  2/20/2024

  Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

• Accelerate Biologics Product Release With Seamless Viral Testing

  6/23/2025

  Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.