Whitepapers

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• Solutions for comparing innovator and biosimilar mAbs • Biosimilar case studies

The Synergy Tube is a BCT specifically designed to optimize nucleic acid recovery and cancer tumor cells (CTC) from the point of blood draw. The Synergy Tube and proprietary stabilizer dramatically improve the quantity and quality of these components for downstream genetic diagnostics.

-Higher integrity assurance is needed for single-use systems -An integrity-testing strategy may be required to meet regulatory expectations -New scientific and technological approaches offer stronger integrity

This report details how using high capacity TOYOPEARL AF-rProtein A HC-650F resin will reduce production costs, on a per-gram produced basis.

Download this application note to learn about hazardous drugs basics - listing through storage, engineering controls and training programs, and why you shouldn’t wait, regardless of initial enforcement for your facility.

Learn how regulators define temporary memory and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.

To ensure that no contaminating or hazardous residual components remain after protein purification during biologic development, additional sanitization steps may be required for the instrumentation utilized during these processes.

A new hydrophobic anion exchange mixed-mode resin has been developed to overcome existing challenges in antibody purification. Described here are two case studies on the purification of an acidic and a basic antibody in bind-elute and flow-through modes. The results demonstrate the ability of this resin to improve process productivity and economy.

• Analytical method development and testing tips • Using automation in cell-line development • Boosting efficiency with mechanical pipettes

ValPlus™ provides pharmaceutical manufacturers increased confidence in the cleanliness of the tubing products they use in critical applications. This whitepaper describes ValPlus™ testing protocols, results obtained, and value to manufacturers.

This application note demonstrates that the TSKgel® FcR-IIIA-NPR affinity column provides fast assessment of biologic activity and glycoform patterns of antibodies.

Download the White Paper and learn how detailed characterization can guide successful development of gene therapy products.

AAE and MS integration enables comprehensive HCP analysis, facilitates process development, and helps determine whether your HCP ELISA is fit for purpose of process monitoring and product lot release.