Entegris

Wed, Sep 21, 2022 2:00 PM EDT This webinar will review the key considerations and gaps in evaluating freeze/thaw solutions, examine the elements of a dedicated technology center to bridging these gaps and development risks, and explore successful case studies of a technology center optimizing processes and speed-to-market.

Tue, Aug 23, 2022 11:00 AM EDT Staying ahead of coming regulatory concerns surrounding particulates in cell and gene therapy manufacturing. Do you know how many particles are in your biomanufacturing process and what to do to reduce them?

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.

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.

*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*

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.

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.