Insights On Quality Control

  1. Accelerating The Development And Scale-Up Of mRNA Vaccines 3/2/2022

    Learn how downstream considerations can make the difference between success and failure on the path towards the commercialization of mRNA vaccines.

  2. Introduction To USP <922>: General Chapter For Water Activity Measurement 3/24/2022

    This article summarizes the importance of water activity and how laser-based headspace analysis can be used for water activity determination.

  3. Formulation Development Strategy For Early Phase Human Studies 1/27/2022

    Determining bioavailable formulation for animal PK, GLP toxicity, first-in-human, and first-in-patient is challenging. Drug delivery systems are usually used for poorly soluble and bioavailable compounds.

  4. 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. 

  5. How To Understand ASTM E2500 12/21/2020

    ASTM E2500 introduced the term “verification” but was essentially silent on the idea of “commissioning” and the term “qualification.” ASTM is a minimum standard, and teams are free to go beyond this minimum as long as the basic provisions are met. There are four basic approaches in the industry currently.

  6. Complex Pump-Driven Blending In A Bioprocess Application 7/8/2021

    There are quite a few applications that require multiple streams to converge into a single process flow. Two such examples are buffer formulation and liquid chromatography gradient elution. 

  7. 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.

  8. Making Sense Of Analytical Standards In Pharma QC 4/7/2022

    This webinar offers information on metrological traceability, the hierarchy of reference materials, certificates of analysis, reference material formats and uses, and fit-for-purpose selection considerations.

  9. 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.

  10. Influence Of Humidity On Powder Characteristics Of Pharma Powders 3/26/2021

     In this article the Anton Paar powder shear cell was used to determine different powder properties and processes such as flow behavior and caking at a wide range of relative humidity (7% to 95%).