Clinical products
April
18
2012

Miltenyi Biotec offers comprehensive systems and services to pioneering biomedical and clinical research.

With the CliniMACS® Cell Separation System, based on MACS® Technology, Miltenyi Biotec has successfully taken the step from research into clinic. The CE-marked, closed CliniMACS® System meets the stringent requirements of clinical-grade separation of almost any cell type. The CliniMACS® Plus Instrument is an automated cell separation system based on MACS® Technology. It enables the operator to perform clinical-scale magnetic enrichment of target cells or depletion of unwanted cells in a closed and sterile system. The CliniMACS Plus Instrument is CE-marked for clinical use in Europe and is used for the separation of a variety of human cell types in conjunction with a cliniMACS tubing set,a CliniMACS reagent, and the CliniMACS PBS/EDTA buffer

The TheraSorb™ product division of Miltenyi Biotec offers a platform for therapeutic apheresis. Using the CE-marked LIFE 18™ apheresis unit, pathogenic components can be selectively eliminated from plasma by immunoadsorption.TheraSorb™ Therapeutic Apheresis is based on the selective removal of pathogenic substances, i.e. substances, that cause diseases, from the patient’s plasma (liquid part of the blood).
Apheresis, from the Greek word “to take away” describes the process in which the blood is processed through an apparatus that separates out a particular constituent and returns the remainder to the patient.

During Apheresis, target molecules are selectively removed while the plasma is re-infused into the patient. Hence, larger volumes of plasma can be processed that in therapeutic plasma exchange.  Since no substitution fluid is required, the treatment is usually very well tolerated.
Different adsorbers in the TheraSorb product line can be used to selectively remove either undesired immunoglobulins (antibodies), Low Density Lipoprotein (LDL, “bad cholesterol”) and Lipoprotein(a) (Lp (a)) or the plasma proteins fibrinogen and C-reactive protein (CRP

The CryoMACS® Freezing Bags consist of a freezing bag and a corresponding overwrap bag and have been precisely developed to set standards for cryopreservation. CryoMACS Freezing Bags are available in Europe as CE-marked medical devices and are marketed in the US under FDA 510(k) clearance.
The CryoMACS Freezing Bags are the right step towards more safety in cryopreservation. The freezing bag with its corresponding overwrap bag provides potential extra security and conforms to current cassette storage systems. The advanced bag design and a broad range of different sizes offer convenient handling and flexibility for various applications.

MACS GMP Products are designed and produced in accordance to GMP standards. These new tools provide integrated solutions for ex vivo cell culture processing