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.

• Vial Breakage During Lyophilization: Root Causes And Mitigation

  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.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

• Effective Staffing Plans For GMP Drug Manufacturing Facilities

  8/12/2024

  In the manufacturing industry, the proper planning and staffing of GMP facilities and production lines are crucial for efficient operations and successful outcomes.

• Method Migration Of A Normal Phase HPLC Method For Tocopherols

  9/17/2024

  The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.

• A Powerful Non-Destructive Tool For Tablet Characterization

  10/6/2025

  Discover how X-ray micro-CT provides vital, non-destructive analysis of a tablet’s internal 3D physical structure. This structural insight is essential for troubleshooting defects and confirming performance.

• A Comprehensive Solution For Critical Sample Analysis

  6/19/2024

  Discover how Germfree Laboratories overcame challenges for the Royal Canadian Mounted Police by designing a mobile lab with advanced biocontainment and state-of-the-art communication systems.

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

  10/15/2024

  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.