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GMP PROTEINS FROM OUR NEW STATE-OF-THE-ART FACILITY

The rapidly growing number of cell therapy clinical trials worldwide and the ultimate push toward commercialization has resulted in an increased demand for larger quantities of GMP-grade animal-free proteins for clinical manufacturing. Our new 61,000 square foot animal-free GMP manufacturing facility was built to allow Bio-Techne to address this need. This facility is equipped with state-of-the-art manufacturing and quality control technologies and is backed by R&D Systems experienced manufacturing, quality, and regulatory teams. With the completion of this new facility, we now have the ability to produce larger quantities of GMP-grade proteins with lot-to-lot consistency, GMP process capabilities for patient safety, and the scalability necessary to support large clinical trials and future successful therapeutics. “Our new facility gives us the scalability and the capacity to bring our GMP-grade protein business to the next level, providing a reliable source of the highest quality proteins to support the rapidly growing cell and gene therapy market.”

– Chuck Kummeth | Bio-Techne’s President and Chief Executive Officer

• USP Chapter <1043>, Ancillary Materials for Cell, Gene, and Tissue-Engineered Products

• USP Chapter <92>, Growth Factors and Cytokines Used in Cell Therapy Manufacturing

• Ph. Eur. General Chapter 5.2.12 , Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products

• Our new facility is completely animal-free and is dedicated solely to manufacturing GMP proteins

• Ensure supply chain through commercial phases

• No need to spend time/money requalifying lots, we can reserve an entire lot for your workflow

• Seamless transition from RUO to GMP

• Facility is optimized for scale to meet growing demand

• ISO 5/7/8 cleanrooms for the entire production process

CERTIFICATIONS AND REGULATORY GUIDELINES FOLLOWED IN THE GMP MANUFACTURING FACILITY

KEY FEATURES OF OUR NEW FACILITY

CHOOSE A PARTNER THAT CAN GROW WITH YOU ON YOUR PATH TO CELL THERAPY MANUFACTURING SUCCESS

Global info@bio-techne.com bio-techne.com/find-us/distributors TEL +1 612 379 2956 North America TEL 800 343 7475 Europe | Middle East | Africa TEL +44 (0)1235 529449 China info.cn@bio-techne.com TEL +86 (21) 52380373

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Analysis of the Activity, Purity, and Lot-to-Lot Consistency of GMP-grade Recombinant Human IL-7. (A) Three independent lots of GMP-grade Recombinant Human IL-7 (R&D Systems, Catalog # BT-007-GMP) were tested for their ability to stimulate proliferation of PHA-activated human peripheral blood lymphocytes. The ED

50 for this

effect is 0.100-0.500 ng/mL. Each trace on the graph represents data obtained from GMP-grade Recombinant Human IL-7 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B) MALDI-TOF analysis of GMP-grade Recombinant Human IL-7 (R&D Systems, Catalog # BT-007-GMP) shows a major peak at 17501 Da. (C) SDS-PAGE analysis of GMP-grade Recombinant Human IL-7 (R&D Systems, Catalog # BT-007-GMP) under reducing (R) and non-reducing (NR) conditions and visualization by Coomassie® Blue staining shows a single band at 17 kDa.

Analysis of the Activity, Purity, and Lot-to-Lot Consistency of GMP-grade Recombinant Human IL-10. (A) Three independent lots of GMP-grade Recombinant Human IL-10 (R&D Systems, Catalog # 1064-GMP) were tested for their ability to stimulate proliferation of MC/9-2 mouse mast cells. The ED

50 for this effect is 0.0750-0.750 ng/mL. Each

trace on the graph represents data obtained from GMP-grade Recombinant Human IL-10 from a different manufacturing run, demonstrating the lot-to-lot consistency of the protein. (B) SDS-PAGE analysis of GMP-grade Recombinant Human IL-10 (R&D Systems, Catalog # 1064-GMP) under reducing (R) and non-reducing (NR) conditions and visualization by Coomassie® Blue staining shows a single band at 18 kDa and 16 kDa, respectively.

GMP-GRADE PROTEINS CURRENTLY BEING MANUFACTURED IN OUR NEW FACILITY

GMP-grade Recombinant Human IL-7 (Catalog # BT-007-GMP), GMP-grade Recombinant Human IL-10 (Catalog # 1064-GMP), and GMP-grade Recombinant Human IL-15 (Catalog # BT-015-GMP) are the first proteins that are being produced out of our new GMP facility.

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