INSIGHTS ON QUALITY CONTROL

• Mitigating CMC Issues Using A Holistic Approach To Developability Assessment

  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.

• 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.

• N-Linked Glycan Analysis Of NISTmAb

  With the right glycan analysis kit, you can achieve a 1-minute-per-sample analysis rate, along with streamlined and high-throughput glycan analysis assay for all phases of biopharmaceutical development.

• Nitrosamine Impurities Deadline: Are Your Products Compliant?

  The FDA nitrosamine contamination guidance set a deadline of August 1, 2025, for all drug manufacturers and market authorization holders to comply fully with the NDSRI limits set.

• Automated Data Integrity In Sterility Testing

  7/10/2023

  Explore trends and challenges in microbiology QC with Anne Weeks, a senior field marketing manager at MilliporeSigma. She discusses workflow automation and introduces a customizable MTR solution.

• Accelerate Your R&D And QC With These 3 Key Analysis Methods

  5/4/2024

  Learn about three key thermal analysis methods for fast and effective characterization and quality control: differential scanning calorimetry, thermogravimetric analysis, and sorption analysis.

• Thermal Analysis In The Pharmaceutical Industry

  12/30/2024

  Thermal analysis techniques provide valuable insights into pharmaceutical material properties, ensuring compatibility, stability, and quality control in drug development and production processes.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  6/18/2024

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  12/9/2024

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.