GMP N-2 MAX Media Supplement (100X), Animal-free

Serum-free and animal-free media supplement for ex vivo cell and tissue manufacturing under GMP culture conditions.

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:

Product Testing

Stability and Storage

Store in the dark at < -20 ^°C in a manual defrost freezer. Do not use past the expiration date.

Safety Information

• 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.

Limitations

• 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.

Production

• All manufacturing procedures for this product use animal-free labware and raw materials.

Quality Assurance

• Low Endotoxin Level.
• No impairment of biological activity.
• High quality product obtained under stringent conditions.

Please read our complete Animal-Free Statement.

The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

We suggest you print and retain a copy of these End User Terms of Use of Product for your records. The End User is aware that R&D Systems, Inc. sells GMP products for preclinical or clinical ex vivo use and not for in vivo use. The End User further agrees, as a condition of the sale of R&D Systems' GMP products that: a) the End User will not use this GMP Product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the Institutional Review Board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.

R&D Systems, Inc. has the right, at its sole discretion, to modify, add or remove any terms or conditions of these End User Terms of Use without notice or liability to you. Any changes to these End User Terms of Use are effective immediately following the printing of such changes on this product insert. The most recent version of these End User Terms of Use of Product may be found at: RnDSystems.com/Legal.

You agree to review these End User Terms of Use of Product to ensure any subsequent use by you of R&D Systems' GMP Products following changes to these End User Terms of Use of Product constitutes your acceptance of all such changes.

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.