INSIGHTS ON QUALITY CONTROL

• Accelerate Biologics Product Release With Seamless Viral Testing

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

• Data Intelligence Requires An Intelligent, Data-Driven Approach To Digital Transformation

  An intelligent and data-driven digital transformation is the key to data intelligence. Discover how in 5 simple steps.

• Achieving Licensing For A Healthcare Solution

  Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.

• Quantitative Determination Of Amorphous And Crystalline Drug In Polymer Microspheres

  Biodegradable polymer microspheres control drug release through crystalline and amorphous properties, analyzed using DSC, MDSC, and TGA to determine composition and stability for precise delivery.

• 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.

• Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity

  6/19/2024

  Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  7/16/2025

  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.

• Leachables Method Development, Validation And Relevant ICH References

  5/16/2025

  It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  5/7/2024

  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>.