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.

• Secondary Packaging: Inspection, Brite Stock Bottle Labeling, And Cartoning

  Gain insight into a coordinated, around-the-clock approach that demonstrates how packaging efficiency can keep pace with urgent pharmaceutical launches and tight commercialization timelines.

• The Essential Ingredient For GxP Training Innovation

  Advanced learning tools depend entirely on the health of the underlying training matrix. Establish a clean, data-driven framework to reduce compliance risks and recover lost operational hours.

• 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.

• 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.

• Aseptic Expertise And Delivery Of Services

  8/20/2024

  A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

• High Precision Mass Inspection With Accuracy Of ±0.5 mg Achieved

  7/2/2026

  Explore how advances in capsule checkweighing technology enable more precise mass inspection, helping improve quality control, reduce variability, and meet increasingly stringent production requirements.

• Development To Large-Scale cGMP Production

  7/25/2024

  For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  2/24/2026

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.