Any component and raw material used at a later stage of the biomanufacturing process is considered a risk, as it could add a bioburden to the final drug product.
While being essential, chromatography steps are often a challenge as they are highly process specific and might be present from early to late downstream. Therefore, information is crucial for manufacturers when selecting chromatography methods and products.
Our new category Emprove® Chromatography addresses the specific needs when selecting and qualifying our chromatography resins.
Speeds up resin qualification and supports regulatory filing preparation. It includes content on manufacturing processes, product characterization, regulatory certificates, storage and shelf life information, and more.
Free of charge*
Supports quality risk assessment by offering extended information on quality management system, supply chain, supplier and process evaluation statement, as well as stability data.
Supports process optimization efforts as well as extended and safety risk assessment. It contains extractables profiles aligned with current draft** of USP<665>. It also includes information on elemental impurities, residual solvents, product quality reports and analytical procedures.
* The Material Qualification Dossier is free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.
** Status May 2020
Unlock Full Access to all dossiers today with the Emprove® Suite Subscription.Subscribe
|Product||Catalog Number||Material Qualification Dossier||Quality Management Dossier||Operational Excellence Dossier|
|Fractogel® EMD COO (M)||116886||✓||NEW||TBD|
|Fractogel® EMD DEAE (M)||116883||✓||NEW||TBD|
|Fractogel® EMD DMAE (M)||116884||✓||NEW||NEW|
|Fractogel® EMD SE Hicap (M)||114894||✓||NEW||TBD|
|Fractogel® EMD SO3 (M)||116882||✓||NEW||✓|
|Fractogel® EMD SO3 (S)||116890||✓||NEW||TBD|
|Fractogel® EMD TMAE (M)||116881||✓||NEW||✓|
|Fractogel® EMD TMAE (S)||116887||✓||NEW||TBD|
|Fractogel® EMD TMAE Hicap (M)||110316||✓||NEW||TBD|
|Fractogel® EMD TMAE Medcap (M)||116885||✓||NEW||TBD|
|Fractogel® EMD BioSEC (S)||110317||NEW||NEW||TBD|