INSIGHTS ON DOWNSTREAM MANUFACTURING

• Eshmuno® CMX — A Novel Mixed Mode Cation Exchange Resin For The Purification Of Glycoproteins

  With the outbreak of COVID-19, the most severe pandemic in the 21st century so far, a feverish search for therapeutic treatment and vaccinations has just started. A substantial number of approaches are focusing on the coronavirus S glycoprotein, a surfaceexposed protein that mediates the entry of the virus into the host cells. The aim of this technical note is to provide a description of the capture and subsequent purification of glycoproteins.

• Hydrophobic Interaction Chromatography Resins For Next-Gen Challenges

  To solve downstream separation and purification challenges for many biotherapeutic modalities, a suite of hydrophobic chromatography resins has been developed to cover a wide range of hydrophobicity. 

• Biopharmaceutical Process Characterization

  Laboratory scale process characterization provides in-depth process understanding and documentation of a manufacturing process needed to establish critical product and process parameters, determine proven acceptable control ranges and minimize the risk of manufacturing failures at production scale. Here we present process development and characterization strategies at Samsung Biologics required to support commercial scale manufacture of antibody therapeutics. In this webinar we will discuss approaches to demonstrate process understanding needed to develop a robust and scalable manufacturing process to support successful GMP manufacture of biologics.

• Ensure Sterility In End-To-End Bulk Management

  A CMO was experiencing sporadic product loss through cross contamination. To mitigate risks for further losses through contamination, the innovative CMO was looking for a reliable approach to guarantee sterility in their processes from downstream to fill & finish by all means.

• Explore Selectivity With Eshmuno® CMX Chromatography Resin

  Eshmuno® CMX chromatography resin is a highly selective mixed mode chromatography resin for difficult to purify mAbs, ADCs and fusion proteins.

• ADC Separation: Mixed Mode Cation Exchange Chromatography In A mAb Process

  This application note describes the steps followed and considerations taken during the development of antibody drug conjugate separation using a mixed mode cation exchange chromatography step.

• Cytograde™ pDNA: Manufacture pDNA Without Sacrificing Quality Or Budget

  If plasmid DNA (pDNA) is integral to your biopharmaceutical production process, are you integrating it as effectively as possible? Find out how Cytovance helps manufacturers realize cost-efficacy -- as well as manage risk -- with Cytograde™ pDNA.

• Standardization And Control - Protecting Your People, Product And Reputation

  Process variation or operator error in downstream processing can have huge consequences for biopharmaceutical manufacturers, CMOs (contract manufacturing organizations) and CDMOs (contract development and manufacturing organizations). Using a bioprocessing system that allows manufacturers to apply pre-defined recipes for sterile filtration and/or dispensing it removes the variability and potential for human error that is inherent in manual processes.

• The Cost Of Failing To Protect Your Final Biopharmaceutical Product

  Read how automating and enclosing bulk fill operations can reduce the risk of human error in the bulk filling process to protect your product at its most valuable stage.