Entegris

Articles by Entegris

Bench-scale filterability studies play a critical role in optimizing sterile filtration in biopharmaceutical manufacturing. By guiding the selection and sizing of filters, these studies help streamline processes, improve scalability, and reduce costs. Through data-driven case studies, this paper highlights how the strategic use of pre-filters and membrane materials can maximize throughput and minimize filter fouling.

Sterile filtration is essential within many steps of a bioprocessing operation, both upstream and downstream, ensuring the biopharmaceutical product’s proper performance, safety, and quality. When seeking to maximize filtration efficiency, it helps to understand how sterile filtration and single-use systems work together, as well as how optimizing the filter design for specific applications can enhance performance.

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.

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*

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.

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.

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.

Risk Mitigation for Single-Use Cold Chain Distribution

The cold chain distribution of biopharmaceutical products is hampered by product loss from brittle components and temperature excursions. Learn about a risk-mitigation strategy and study results that highlight the importance of choosing the right low-temperature materials, use sensors for monitoring the distribution process step, and testing to qualify a single-use cold chain solution. Monday, Oct. 12, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after final airing until Oct. 12, 2021.

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