Whitepapers

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.

Aseptic cleaning is among the most important and expensive cleanroom maintenance tasks. Learn how to make validated sterile wiping more effective, economical & easier.

• Purification methods for charged oligonucleotides • HIC is very effective for purifying a DMT-on oligonucleotide

Good pipetting ergonomics requires proper tool selection and optimized working environment. This whitepaper explores many published studies and other factors related to pipetting ergonomics.

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.

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

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.

Designed to solve complex downstream separation and purification challenges for many biotherapeutic modalities, a suite of hydrophobic chromatography resins (POROS HIC) has been developed that cover a wide range of hydrophobicity.

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

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.