Insights On Quality Control

  1. Water Activity And Primary Packaging For Oral Solid Dose Products 2/17/2022

    The draft of the general chapter USP<922&GT says water activity determination can be used to assess the level of protection of primary packaging for an oral solid dosage product over its entire shelf life.

  2. Ensuring Container Closure Integrity Of A Gene Therapy Cancer Vaccine Needing Deep Cold Storage 7/22/2020

    A gene therapy clinical trial was halted due to CCI issues in deep cold storage. A CCI test method was developed that enabled non-destructive CCI testing of product vials at these cold temperatures. 

  3. Spray-Dried Dispersions Enable Local Delivery For Lung Cancer 4/20/2021

    Learning more about spray drying as well as two case studies detailing its success serve as a critical tool in developing innovative and effective lung cancer therapies.

  4. Effects Of Deep Cold Storage At -80°C On The Container Closure Integrity Of Sterile Product Vials 7/27/2020

    Studies have shown that deep cold storage temperatures can introduce risk to the container closure integrity (CCI) of vial-rubber stopper combinations traditionally used to fill sterile pharmaceutical products. The material properties of the primary packaging components at these low temperatures can sometimes result in gaps appearing at the sealing surfaces.

  5. CCI Testing Method Development For Vials Stored At -80C 7/22/2020

    It is essential to generate robust data that demonstrates the maintenance of seal integrity during deep cold storage and/or transport which, in turn, requires a robust container closure integrity test method.

  6. LC-MS/MS Method To Analyze 20 Amino Acids 4/8/2022

    This application note outlines an LC-MS/MS method for analyzing all 20 amino acids, without derivatization, utilizing the Supel™ Carbon LC column.

  7. Robotics & Automation On The Brink Of Transforming Pharma QC 4/1/2022

    In QC, there is still huge potential to accelerate the release of safe products. Here we review ways to boost the reliability, data integrity and productivity of microbiological testing.

  8. New High Speed Multi-Purpose Fill Line 6/11/2021

    Our fully contained and integrated OPTIMA line utilizes scan isolated barrier technology to ensure the required sterility for fill finish while offering flexibility to meet your cGMP, clinical, and commercial drug product manufacturing needs.

  9. Modernizing Biopharma Manufacturers To Improve Quality And Safety 1/10/2022

    Read how proven, scalable digital solutions to modernize pharmaceutical product innovation and development gives enterprises an edge in meeting the manufacturing guidelines for pharmaceuticals while elevating the entire industry.

  10. Our Biotech Success - Corvus 4/13/2022

    Corvus, a small biotech developing precision medicines, primarily for oncology patients, was seeking to develop a monoclonal antibody called CPI06, now known as Mupadolimab.