Cell culture media (CCM) drive the productivity of upstream processes and help ensure critical quality attributes of the final drug product. Because of this critical role in manufacturing, along with increased regulatory focus on raw materials, it is recommended that media be included in drug product risk assessments.1,2
To ease the burden of collecting the extensive information needed for a thorough assessment, Cellvento® CHO cell culture media are now included in our Emprove® Program.
Speeds up media qualification and supports regulatory filing preparation. It includes information on the manufacturing process and media homogeneity.
Furthermore, it includes regulatory certificates, example certificates of analysis, shelf life information and more.
Free of charge*
Supports risk assessment activities by offering extended information on the quality management system applied and supply chain information. It contains also media stability data.
Supports process optimization efforts. It contains information on typical levels of trace elements, information on origin of raw materials used, as well as 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.
Unlock Full Access to all dossiers today with the Emprove® Suite Subscription.Subscribe
|Product||Article Code||Material Qualification Dossier||Quality Management Dossier||Operational Excellence Dossier|
|Cellvento® 4CHO-X COMP||103840||
|Cellvento® 4Feed COMP||103796||New||New||New|