Entegris is playing a supporting but crucial role in our customers’ efforts to develop and manufacture therapies for COVID-19. We have taken several critical steps to bolster supply chains, auditing, and validation programs, and are undergoing rapid scale-up to meet commercial demand for potential successful candidates in the pipeline. You can be certain that we are committed to remaining a strong partner and as such, have dedicated ourselves to maintaining critical operations by relying on our business continuity plans and leveraging trusted supply partners.
Learn about Entegris’ COVID-19 programs for maintaining critical operations and accessibility, or more about our participation in the BioPhorum and Rx-360 Joint Audit Model and enhanced Aramus™ 2D bag assembly validation guide improvements.
Accelerating Cell and Gene Therapy Development
This report created by Pharma IQ produced in collaboration with Entegris draws on the insights and experience of industry professionals from organizations the likes of Entegris, AstraZeneca and PPD. It outlines the challenges that prevent the acceleration of CGT development, including manufacturing and scaling, and offer solutions for overcoming them.
To help minimize travel during the pandemic we have taken steps to enable supplier and process qualification remotely by participating in the BioPhorum Operations Group – Joint Audit Program. BioPhorum and Rx-360 worked together to create the Joint Audit Model in the single-use systems supply chain with the aim to deliver consistent, rigorous, and cost-effective quality audits that will alleviate the audit burden while ensuring biopharmaceutical manufacturers are in control of their supply chain. Our audit report can be licensed through Rx-360.
Aramus™ Bag Assembly Validation Guide
This validation guide addresses key requirements needed to validate Aramus™ bag assemblies for use in regulated applications. It contains sourcing, testing, and regulatory compliance summaries that validate Aramus bag assemblies meet those requirements.
Low Risk Frozen Distribution of Single-Use Bags for Bioprocessing
As pipelines expand with more complex and temperature-sensitive products, the distribution of high-value active pharmaceutical ingredients (API’s) between development sites, clinical sites, and drug manufacturers for further processing will become a more relied upon paradigm. This paper provides guidelines for employing sensors for monitoring critical shipment parameters, utilization of more suitable low-temperature materials and packaging, and qualification and evaluation through simulated standards and testing real-world transit lanes.
Aramus™ Single-Use Bag Assembly E&L Particle Size Testing
Parenteral drugs administered by injection to patients, like vaccines, should essentially be free of visible particles. USP <788> for Particulate Matter in Injections dictates how to quantify subvisible particles present in injectable drugs and sets acceptable particle concentration limits. See how we apply this testing for our Aramus™ bag assemblies.
Subvisible Particulate Matter Testing
USP and other agencies such as EP, JP, and ChP have established test methods to assure the minimization of particle counts in intravenous injections (parenteral drugs) and ophthalmic solutions. Tests are in place for both visible and subvisible particulate matter. This paper details the various USP subvisible particulate matter tests available to assure the minimization of particle counts in intravenous injections.
Global Engage Webinar: Biomanufacturing with Fluoropolymer Single-Use Systems
In this webinar, Julien Muzard, Field Applications Technologist, will discuss recent biocompatibility data obtained using our gamma-stable, fluoropolymer platform and its advantage in a modern manufacturing environment for handling almost any biological fluid.
Single-Use System Design for Cryogenic and Cold Temperature Operations
Join Ross Acucena, applications director, as he discusses single-use system design for cGMP cryogenic operations. Single-use technologies have been a valuable tool to help speed to market cell and gene therapies. Cryogenic operations play a critical role in many processes.
Risk Mitigation for Single-use Cold Chain Distribution
In this webinar we will share risk mitigation study data showing the utility of low temperature suitable materials and packaging, employment of sensors for monitoring shipments, and better qualification and evaluation through simulated standards and real-world transit.
USP Particulate Testing
USP Particulate Testing Webinar – View our presentation covering particle sizing compliance for USP standards for parenteral injectable drug manufacture and other therapeutics and requirements of USP <788>, <787>, <789>, and <729>
Learn more about our Life Sciences solutions
FIND AN OFFICE LOCATION OR SPEAK WITH AN EXPERTContact Us
Quick-turn custom manufactured for single-use bioprocessing systems.
With decades of experience, we can fabricate unique tube sets and manifolds to your exacting specifications. We have solutions for secure fluid transfer, aseptic filling, sterile processing or storage, bioreactor filtration and support, and so much more.
Combining product innovation with quick-turn customization to deliver a total solution for your upstream and downstream needs.
Our comprehensive bag solutions, motion bioreactor bags, mixing systems, and microcarrier separation systems meet emerging requirements of fast-growing, single-use bioprocessing applications.