Description
Applications
- CliniMACS Formulation Solution has been developed for cell based drug product formulation.
- ClinMACS Cryo Supplement, 3× has been developed for cell based drug product formulation and deep storage freezing.
Disclaimer
The CliniMACS® System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations - e.g., for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved as a Humanitarian Use Device (HUD), authorized by U.S. Federal law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this indication has not been demonstrated. Other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application, Investigational Device Exemption (IDE) or FDA approval.
CR/GMP products are for ex vivo cell processing only, and are not intended for human in vivo applications. CR/GMP products are designed, manufactured and tested under an ISO 13485 quality management system and are in compliance with relevant GMP guidelines. They are designed following the recommendations of USP <1043> on ancillary materials. The manufacturing and testing of CR/GMP products of biological origin are in compliance with EP chapter 5.2.12 for “Raw materials of biological origin for the production of cell-based and gene therapy medicinal products”.
Overview
CliniMACS® Formulation Solution is intended as excipient for processing of human cells from heterogeneous cell populations in combination with the CliniMACS Prodigy® System. The Formulation Solution consists of a salt solution which is already supplemented with 2.5% human serum albumin (HSA).
CliniMACS Cryo Supplement, 3× is intended as excipient together with the CliniMACS Formulation Solution for processing of human cells from heterogenous cell populations in combination with the CliniMACS Prodigy® System. The Cryo Supplement 3× contains of a sugar solution containing 22.5% DMSO. In combination with the CliniMACS Formulation Solution the Cryo Supplement 3× serves as a freezing solution with 7.5% DMSO final concentration.
Both products are provided as ready-to-use solutions in bags and can be sterile welded onto tubes of a CliniMACS Prodigy Tubing Set.
