MilliporeSigma was commissioned to perform the technology transfer and optimization of bioprocess chemistry and associated analytical methods for the production of antibody-drug conjugate ADC-X.
Steps to ensure products are free from microbial contamination and achieve a sufficient level of risk mitigation against potential bioburden issues for these applications.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.
Fast and efficient process development and scale-up contributes to a shortened time to market. This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.
Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.
Cell culture production of recombinant proteins results in protein sample contaminated with host cell DNA. This can lead to increased viscosity of the feedstream and interfere with downstream purification steps. Design a process purification process with these new strategies.
Understand the challenges of IgM purification and how to design a scalable non-affinity based purification platform for manufacture of diagnostic IgMs
Review the biological properties of IgM antibodies that make them very effective vehicles for in vitro diagnostics and therapeutics.
In this presentation, Dr. Hussain discusses an extraction-free method in which samples are subjected to digital PCR.
Droplet Digital PCR (ddPCR) simplifies the quantification of host cell DNA in process development, quality control, and biomanufacturing processes.
See how GE Healthcare products that are currently used in the cell processing workflow for cell therapy.
Overcome the challenges of separating mAb momomers from aggregates and other purification obstacles.
Accurate monitoring of dissolved oxygen, carbon dioxide and pH is essential to a successful drug production process.
Start immediately, reduce costs, and sample safely with this sampling system.