Cell And Gene Articles, App Notes, Case Studies, & White Papers

1. When Other CROs Said No, We Said Yes — To The Nearly Impossible 7/30/2019

   The sponsor was finishing its Phase III study for an antimicrobial, anti-infective drug and needed to complete its NDA submission in just 6 months. The development effort went back more than a dozen years, and having performed none of the clinical studies on the drug. This CRO took the unusual step of negotiating a rolling submission, providing by the due date enough information for the agency to begin its review, and filling in the rest over the following weeks.

2. Adenovirus Production In Single-Use Bioreactor System 3/8/2019

   Rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using such a system.

3. Understanding And Controlling Raw Material Variation In Cell Culture Media 9/5/2019

   An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.

4. Robust Field Guide To qPCR 4/9/2020

   qPCR remains the gold standard for validation of microarray and next generation sequencing data and the method of choice for both clinical and basic research labs for a wide range of applications. However, there remains general concern about the production of data that truly reflects the tested experimental conditions. We have developed a comprehensive guide to performing the ultimate qPCR experiment. The following is a snapshot of the critical steps needed to achieve excellent results.

5. Virus Reduction Of An Affinity Capture Step: Viral Clearance For Protein A 5/17/2019

   Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.

6. Quantitating Binding Similarities In IgG Fcγ Receptor Analysis 5/23/2019

   Critical quality attributes are fundamental to regulatory compliance in drug development and manufacturing. Learn how surface plasmon resonance has been applied for protein characterization of antibody effector function.

7. Effectively Securing Cell And Gene Therapies With Closed Systems 2/5/2020

   Single-use connectors offer an easy-to-use method for flow path sterility and integrity during cell and gene therapy manufacturing. It also enables the protection needed to avoid costly failures from contamination.

8. Minimizing Errors And Saving Time In Drug Receipt Processes 3/20/2019

   The speed-accuracy trade-off is a well-known phenomenon in psychology for processes requiring human input: the faster you go, the more likely it is that errors will be introduced into the system. 

9. CAR-T Cell Lentiviral Transduction By Spinoculation 5/21/2020

   There is a growing need to close and automate manufacturing of chimeric antigen receptor (CAR)-T cell therapies. Learn how to streamline this step while keeping flexibility during process development.

10. Benefits And Challenges Of Driving Modernization In Vaccine Development 6/11/2019

    Protein Sciences learned several valuable lessons during the development and final regulatory approval of its recombinant hemagglutinin (rHA) influenza vaccine, Flublok.