MACS GMP Products
- Compliant – manufacture of cellular products according to GMP guidelines
- Optimized – CliniMACS® System in combination with the MACS® GMP Products
The quality of starting materials dramatically influences the properties of the final cellular product. For the development of applications involving cellular therapies, strict procedures according to GMP guidelines are mandatory.
All materials used, such as antibodies, antigens, cytokines, cell culture bags, and cell culture media, must comply with GMP specifications.
Miltenyi Biotec strives to minimize the risk of contamination and maximize the consistency and quality of all its products through highest manufacturing standards, strictly controlled processes and a certfied ISO 9001 quality system.
MACS® GMP activation and expansion tools include GMP-grade monoclonal antibodies and antibody-coated particles (ExpAct Treg Beads) for clinical-grade activation and expansion of cells
MACS® GMP Antigens, including PepTivator® Peptide Pools, recombinant protein and antigen lysate, are designed for the efficient stimulation of antigen-specific T cells.
MACS® GMP Media have been developed for today's requirements for clinical grade manufacturing of cellular products. These next generation cell culture media are adapted to the needs of each cell type and are manufactured under strict quality assessment
MACS® GMP Fluorescent Antibodies have been developed for flow cytometry analysis and subsequent flow sorting of cell populations from heterogeneous human blood products in the clinical setting. A wide range of specificities and fluorochromes are available. A special custom conjugation program has been introduced that allows the GMP-compliant manufacture of fluorescent antibodies.
MACS® GMP Cytokines and Growth Factors are highly active and pure recombinant proteins that enable consistent cell culture results. Highest product standards are ensured by rigorous quality control (QC) tests. Each product is supplied with a lot-specific certificate of analysis (CoA) that confirms the stringent specifications. These products have been developed for today's requirements for clinical grade manufacturing of cellular products and are manufactured in accordance with relevant GMP guidelines.
Cell Culture Bags for expansion or differentiation
Miltenyi Biotec offers MACS GMP Cell Differentiation and MACS GMP Cell Expansion Bags for expansion, generation and differentiation of cells from heterogeneous, hematologic cell populations.
The gas permeable and transparent MACS® GMP Cell Culture Bags have been developed as valuable tools for GMP-compliant cell culturing in functionally closed systems.
- CryoMACS Freezing products for cryopreservation
- Unique bag concept with few welds making CryoMACS® Freezing Bags highly durable
- Corresponding overwrap bag to protect freezing bag and stored product
- Single, sterile packaging in one pouch of both freezing bag and overwrap bag
CryoMACS Freezing Bags and CryoMACS DMSO are the right step towards safe cryopreservation of cells at ultra low temperatures.
- CryoMACS DMSO is a pure and sterile dimethyl sulfoxide supplied in glass vials CryoMACS® Freezing Bagsexcel in proven quality, convenient handling, and are the right step towards safe cryopreservation. CryoMACS Freezing Products have been precisely developed in cooperation with our clients to set standards for cryopreservation. CryoMACS Freezing Bags are for cryopreservation applications at ultra low temperatures. CryoMACS DMSO 10 (EP, USP) is used as a cryoprotective agent.