Entegris

Articles

Optimizing Freeze Thaw Processes for Cell and Gene Therapy Commercialization

Tuesday, April 12th 2022 at 10 am EDT | 7 am PDT | 3 pm GMT Freezing and thawing biotherapeutics requires experienced leadership to navigate material and instrument selection as well as quality, space, regulatory and other considerations in creating a new cold-chain ecosystem. This webinar discusses the design of processes in partnership with a uniquely resourced freeze/thaw technology center.

Frozen Distribution of Single-Use Bags for Bioprocessing

Implementing a few recommended guidelines increases visibility in your distribution lane, incorporates robust materials, and qualifies them against relevant metrics to ensure consistent product quality in the cold chain.

Single-Use Material Selection for Critical Storage Operations in Gene Therapy Development and Scale-up

*Wednesday, May 19, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST* The selection of single-use materials for novel gene therapies, as well as the material’s commercial viability, is crucial especially for those used in storage and cryogenic operations. Learn about key product contact material and process compatibility requirements during this webcast. *On Demand Until May 19, 2022*

Single-use Technology for Frozen Bulk Drug Storage

Explore single-use bag system technologies for freeze/thaw applications in bulk drug substance (BDS) manufacturing. Transitioning to SUT can be an efficient, cost-effective option for biopharmaceutical manufacturers to hit performance targets.

Parenteral Subvisible Particle Testing

This paper details various USP subvisible particulate tests used to assure the minimization of particle counts in intravenous injections and the requirements and technologies used to meet them.

Single-use Control for Frozen BDS Storage

The traditional packaging for frozen BDS applications has significant weaknesses at lower temperatures.  This paper discusses new materials and freeze-thaw systems to meet these challenges.

Fluoropolymer for Efficient High-Density Cell Banking

High-density cell banking accelerates the upstream process by providing concentrated cells to jumpstart a production run. This intensification eliminates many laborious and risky steps used in most labs

Low Risk Frozen Distribution Using Bags

A frozen shipping study conducted on single-use fluoropolymer bags following new guidelines that help to mitigate the risks during frozen shipping while ensuring consistent product quality in cold chain distribution.