Good Manufacturing Practices(GMP)-grade Proteins
As the demand for biopharmaceuticals and the promise of cellular therapies grow,so does the need for high quality growth factors and cytokines used for cell culture. Our experienced Quality and Manufacturing teams will partner with you to ensure we meet all of the requirement necessary to instill confidences as your reagent supplier.
PrimeGene GMP proteins are designed speciﬁcally to meet the stringent requirements necessary！for their use as cell therapy reagents or as ancillary proteins used in manufacturing.
→ Idea for Translational Research
→ Lot-lot Consistency
→ Extensive Documentation
→ Certification and Regulatory Guidelines Followed
Manufacturing in our ISO 9001:2008 certified facility in Minneapoils
WHO TRS,No.882,1992 Annex 1,Good Manufacturing Practices foe Biological Products
USP Chapter<1043>,Ancillary Materials for Cell,Gene,and Tissue-Engineered Products
USP Chapter<92>,Growth Factors and Cytokines Used in Cell Therapy Manufacturing
Protein A Sepharose CL-4B Columns & Protein A Affinity ResinNEW
Protein A Affinity ResinNEW
PrimeGene now offers Protein A resin---Protein A Sepharose CL-4B! It is designed to significantly reduce the cost of the Protein A capture step,offer a standardized platform for bioprocessing applications and meet the industry’s demands for quality and supply expectations.
→ High dynamic binding capacity, and low protein A leaching
→ Reduction in protein A resin cost
→ An animal free fermentation process
→ Manufacturing process that meets ISO9001:2008 quality system standards
→ Security supply chain
→ Ligand: Recombinant Staphylococcus Protein A (rSPA) expressed in E. coli, which contains all ﬁve immunoglobin binding domains (E,D,A,B,C).
→ Bead structure: 4% cross-linked sepharose
→ Particle size: 45–165 μm
→ Mean bead size: 90 μm
→ Ligand density: ~5 mg protein A/ml medium
→ Available capacity: >30 mg human IgG/ml medium
→ Protein A leaching: <10 ng IgG
→ Caustic Stability: 100 cycles with 0.1M NaOH
→ Recommended Flow Velocity: 20-150 cm/h
→ Recommended pH: 3–9, Short term: 2–10