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

1. Scale Your Bioproduction With Large Format High-Flow Connectors 1/3/2020

   Looking to scale up your liquid bioprocessing and decrease transfer times? Learn how high-flow, genderless, large format connectors make scale and efficiency easy and reliable.

2. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures 2/26/2019

   One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

3. Direct-To-Representative Sample Distribution Services 4/30/2019

   One particularly effective approach to promote prescription drug products is to have pharma sales reps ‘hand carry’ samples to the health care practitioners within their territories.

4. Understanding New FDA Guidance For Pediatric Oncology Studies 4/21/2020

   The Research to Accelerate Cures and Equity (RACE) for Children Act requires that any original new drug or biologics license application submitted on or after August 18, 2020, for a new active ingredient must contain reports of molecularly targeted pediatric cancer investigations if the drug is directed at a molecular target that the FDA determines to be substantially relevant to the growth or progression of a pediatric cancer. Learn more about the changes in this article.

5. Droplet Digital Polymerase Chain Reaction 1/15/2020

   Leveraging the hyper accuracy of Droplet Digital PCR (ddPCR), viral and gene therapy developers gain additional confidence in tittering assays and vector copy number determination.

6. Transforming Cancer Research: Digital PCR Technology Plays Integral Role At Cancer Research Center 10/4/2018

   How  digital PCR technology is helping scientists in their quest to break through the current limits of nucleic acid detection and quantification.

7. Business And Legal Risks In Life Science Outsourcing 6/26/2020

   Significant business and legal risks threaten emerging and global life science enterprises. Among those are the industry's extensive reliance on external partners for product development and CDMOs.

8. Rapid Sterility Testing: Viral And Gene Therapy Applications 10/29/2019

   For most cell and gene therapy products, a 14-day testing period for sterility is too long and hinders the timely release of products with a short shelf life or a small window for release to the clinic. Download this white paper to learn how validated, rapid sterility methods better address the needs of cell and gene therapy clients, with faster turnaround and increased throughput.

9. Improved Process Economics Of Humira Biosimilar Purification 1/10/2019

   This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.

10. Controlled Endpoint In Cryopreservation 2/24/2020

    Successful cryopreservation of cells requires a controlled cooling rate. Cooling too rapidly or too slowly could lead to a poorer outcome. This application note demonstrates how controlled-rate cooling is achieved using equipment such as VIA Freeze controlled-rate freezers.