INSIGHTS ON QUALITY CONTROL

• Manufacturing Solutions

  Explore a cutting-edge service in powder blending, encapsulation, tablet compression, and on-site laboratory testing that meets the highest standards to ensure exceptional quality and compliance with cGMP regulations.

• Enhance Peptide Innovation With A High-Quality Supply Of Building Blocks

  To leverage the benefits of peptide therapeutics, identify an experienced chemical material manufacturer that can produce unique peptide building blocks with quality, efficiency, and continuous compliance.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  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.

• 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 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.

• Development Of Separation Methods For GLP-1 Synthetic Peptides

  6/30/2025

  Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  6/19/2024

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows

  2/3/2025

  The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.

• Data-Driven Methods for Ensuring Container Closure Integrity

  12/18/2024

  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.