GMP N-2 MAX Media Supplement (100X), Animal-free
GMP N-2 MAX Media Supplement (100X), Animal-free Summary
Serum-free and animal-free media supplement for ex vivo cell and tissue manufacturing under GMP culture conditions.
- Animal-free formulation that includes recombinant human transferrin and insulin.
- Manufactured under cGMP guidelines
- Equivalent performance to research grade N-2 MAX
- Promotes neural progenitor cell derivation, maintenance, and differentation
- Enhances pluripotent stem cell differentiation
GMP N-2 MAX Description
GMP N-2 MAX Media Supplement is manufactured using animal-free raw materials in an animal-free laboratory following cGMP guidelines. This media supplement can be added to base media formulations to support the expansion of neurons, neural progenitors, and stem cells under cGMP-grade culture conditions. GMP N-2 MAX Media Supplement has been modified from the Bottenstein’s formulation to be compliant for use in ex vivo cell and tissue manufacturing work flows.
This media supplement is produced according to relevant sections of the following documents: USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Eu. Ph. 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.
Benefits of GMP N-2 MAX Media Supplement
GMP N-2 MAX is designed to address raw material challenges for manufacturing pluripotent stem cell and neural progenitor cell-derived therapies, including reducing the manufacturing risks associated with lengthy cell differentiation protocols, eliminating the introduction of animal-containing components, and streamlining research-to-manufacturing transition of raw materials.
GMP N-2 MAX is produced in an animal-free suite at R&D Systems and contains all animal-free components. By eliminating animal-containing components, this supplement helps eliminate the risk and impact of including trace animal components or mammalian pathogens in regenerative medicine manufacturing workflows. GMP N-2 MAX has high lot-to-lot consitency, ensuring consistent performance that will sustain throughout lengthy culture and differentiation protocols. Last, GMP N-2 MAX has equivalent performance compared to the research-grade N-2 MAX Media supplement, simplifying and reducing the time and testing required to make the transition of preclinical to clinical-grade manufacturing.
Supplied as a 100X concentrate and contains the following components:
|Recombinant Human Insulin||2500|
|Recombinant Human Transferrin||10,000|
|Endotoxin Level||< 2 EU/mL for a 1X solution.|
|Mycoplasma||Negative when tested in a ribosomal RNA hybridization assay.|
|Sterility Testing||Tested following USP <71> sterility guidelines.|
|Activity||Supports expansion, maintenance, and differentiation rat cortical stem cells.|
Stability and Storage
Store in the dark at < -20 °C in a manual defrost freezer. Do not use past the expiration date.
- For use in preclinical research or for ex vivo cell and tissue manufacturing
- Not intended for direct administration into humans or animals. Not for parenteral use.
- The safety and efficacy of this product in diagnostic or other clinical uses has not been established.
- This reagent should not be used beyond the expiration date indicated on the label.
- Do not use if package is damaged. Use undamaged and sealed bottles only.
- Results may vary due to variations among cells derived from different donors.
R&D Systems, a Bio-Techne Brand's GMP media are produced according to relevant sections of the following documents: USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Eu. Ph. 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.
R&D Systems' quality focus includes:
- Manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
- Documented processes and QA control of documentation and process changes
- Personnel training programs
- Raw material testing and vendor qualification/monitoring
- Fully validated equipment, processes and test methods
- Equipment calibration schedules using a computerized calibration program
- Facility maintenance, safety programs and pest control
- Material review process for variances
- Monitoring of stability over product shelf-life
R&D Systems strives to provide our customers with the analytical characteristics of each product so that customers may determine whether our products are appropriate for their research. The Certificate of Analysis provided contains the following lot specific information:
- Endotoxin level (as determined by LAL assay) performed on each QC lot
- Mycoplasma testing by ribosomal RNA hybridization assay.
- Post-bottling lot-specific activity results (compliance with established specifications).
- Microbial bioburden testing following USP <71> sterility guidelines.
Additional testing and documentation requested by the customer can be arranged at an additional cost.
Production records and facilities are available for examination by appropriate personnel on¬site at R&D Systems in Minneapolis, Minnesota USA.
R&D Systems sells GMP grade products for preclinical or clinical ex vivo use. They are not for in vivo or parenteral use. Please read the following End User Terms prior to using this product.
Animal-Free Manufacturing Conditions
Our dedicated controlled-access animal-free laboratories ensure that at no point in production are the products exposed to potential contamination by animal components or byproducts. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free.
- All manufacturing procedures for this product use animal-free labware and raw materials.
- Low Endotoxin Level.
- No impairment of biological activity.
- High quality product obtained under stringent conditions.
The following limitation applies to R&D Systems' warranty and liability for damages: All products are warranted to meet R&D Systems' published specifications when used under normal laboratory conditions.
R&D SYSTEMS DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, R&D SYSTEMS DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
NOTWITHSTANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN R&D SYSTEMS AND PURCHASER FOR THE PURCHASE OF THE PRODUCTS, R&D SYSTEMS' TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO R&D SYSTEMS FOR THE APPLICABLE PRODUCTS. IN NO EVENT WILL R&D SYSTEMS BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.
Full details of R&D Systems' Terms and Conditions of Sale can be found online at: RnDSystems.com/Legal.
iPSC-derived Neurons Cultured Using GMP N-2 MAX Media Supplement. iPSC-derived neural progenitors were differentiated into cortical neurons in media containing GMP N-2 MAX Media Supplement, GMP SB 431542 (Tocris, Catalog # TB1614-GMP), and GMP Recombinant Human Noggin (Catalog # 6057-GMP). Neurons were re-plated to a lower density, cultured for 3 days, and fixed for immunocytochemistry and visualization of neurite elongation. Cells were stained using Human/Mouse/Rat beta-Actin Monoclonal Antibody (green; Catalog # MAB1420), Neuron-specific beta-III Tubulin Monoclonal Antibody (red; Catalog # MAB1195), and DAPI (blue; Tocris, Catalog # 5748). Representative images of neurons at 60X and 100X magnifications.
GMP N-2 MAX Media Supplement is Comparable to Research-grade N-2 MAX. Rat Cortical Stem Cells (Catalog # NSC001) were cultured for 14 days in media supplemented with 20 ng/mL Recombinant Human FBF basic (Catalog # 233-FB) and either GMP N-2 MAX Media Supplement (Catalog # AR016) or research-grade N-2 MAX Media Supplement (Catalog # AR009). Cells were harvested and stained with PE-conjugated Mouse Anti-Human Nestin Monoclonal Antibody (Catalog # IC1259) or PE-conjugated Anti-Human/Mouse SOX2 Monoclonal Antibody (Catalog # IC2018). Under these conditions, similar yields of Nestin and SOX2 positive cells were observed.
Lot Consistency of GMP N-2 MAX Media Supplement. Rat cortical stem cells were cultured over multiple passages using GMP N-2 MAX and evaluated for the for the maintenance of stem cell markers, SOX2 and Nestin. A) Flow cytometry of SOX2 expression of rat cortical stem cells cultured using four separate lots of GMP N-2 MAX. B) Quantification of flow cytometry data demonstrates a high purity of rat cortical stem cells (% of SOX2-positive and % of Nestin-positive cells) that is consistent across multiple manufacturing lots.
GMP N-2 MAX Media Supplement Supports iPSC-derived Dopaminergic Neuron Differentiation. Human induced pluripotent stem cell (iPSC)-derived neural progenitor cells were differentiated into dopaminergic neurons in medium containing GMP N-2 MAX Media Supplement, GMP DAPT and GMP Recombinant Human BDNF (Catalog # 248-GMP). The medium also contained N21-MAX (Catalog # AR008) and cAMP. Dopaminergic neurons were identified using a Human/Mouse Tyrosine Hydroxylase Antibody (Catalog # MAB7566) and a Neuron-specific beta-III Tubulin Antibody (Catalog # MAB1195)
GMP N-2 MAX Media Supplement (100X), Animal Free
Dilute GMP N-2 MAX Media Supplement 1:100 in basal media before use. The diluted medium may be stored in the dark at 2-8 °C for up to 2 weeks.
Note:For ex vivo cell or tissue manufacturing applications, this supplement should be used in combination with GMP-compliant base media and raw materials
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