CellPrime rTrypsin non-animal origin recombinant trypsin by Merck: High Purity Trypsin for Vaccine Production, Stem Cell Culturing and Insulin Manufacturing

Ensure reliable, virus-reduced cell dissociation and biomanufacturing with CellPrime rTrypsin non-animal origin recombinant trypsin by Merck, developed to meet stringent industry regulations.

Why Choose CellPrime® rTrypsin

• Lower bioprocess risk: Reduces the risk of introducing adventitious viral agents associated with animal origin native trypsin into biomanufacturing processes.
• Supports regulatory expectations: Aligns with increasing advocacy from regulatory agencies and industry associations to replace animal origin process components with recombinant and non-animal origin materials whenever possible.
• Improved process reliability: Helps increase process reliability while facilitating regulatory compliance in biopharmaceutical manufacturing.
• Reliable replacement strategy: Serves as a suitable and reliable replacement for porcine trypsin in processes where animal origin manufacturing aids are being removed.
• Maintains critical cell characteristics: Supports dissociation of adherent cells while preserving the structural and functional integrity of cell surface markers in stem cell workflows.
• Proven fit for biomanufacturing workflows: Demonstrated suitability for key uses, including adherent cell dissociation in vaccine production and use as a manufacturing aid in recombinant insulin production.
• Flexible for different user needs: Is available as liquid and powder stock with identical enzyme activity and comparable performance, and can be formulated as a sterile, GMP-manufactured solution for varied application requirements.

What CellPrime® rTrypsin Is

• Product Classification: Proprietary recombinant trypsin enzyme within a non-animal-origin (NAO) portfolio of cell culture supplements.
• Expression System: Protein expressed from a synthetic DNA construct encoding the porcine gene sequence in a Pichia pastoris host.
• Initial Molecular State: Primary expression as an inactive recombinant trypsinogen precursor.
• Activation Mechanism: Precursor conversion via auto-catalytic activation under controlled parameters to yield a fixed ratio of $\alpha$- and $\beta$-trypsin moieties.
• Manufacturing Standard: Production compliant with GMP guidelines within dedicated facilities meeting non-animal origin requirements.
• Compositional Purity: Formulation devoid of animal-derived components in master/working cell banks, raw materials, and final processing.
• Physical Format: Available in both crystalline powder and liquid stock configurations.
• Dispensing Architecture: Provisioned as a sterile, ready-to-use GMP solution for direct integration into workflows.

Technical Specifications for CellPrime® rTrypsin

• Activated product composition: β-trypsin > 70% and α-trypsin < 20%.
• RP-HPLC peak area values: 77% β-trypsin and 14% α-trypsin.
• Activity unit conversion: 1 unit of trypsin activity using carbobenzoxy-valyl-glycyl-arginine-4-nitril-anilide acetate (Chromozym TRY) as the substrate corresponds to 21 USP trypsin (BAEE) units.

Applications and Use Cases

• Vaccine production: Used to dissociate and resuspend adherent cell lines during seed train extension and harvest in vaccine manufacturing workflows.
• General life science R&D cell culturing: Used to passage adherent cells in routine research cell culture applications (see regulatory guidelines for use in GMP manufacturing).
• Adult human stem cell culture: Used to dislodge adherent cells grown on carriers, including hMSC, while preserving the structural and functional integrity of cell surface markers.
• Recombinant insulin manufacturing: Used as a protease in the maturation of proinsulin to active insulin and serves as a manufacturing aid in recombinant therapeutic human insulin production.

With over 23 years of expertise, Chemical Express is the official distributor of Merck in Thailand. Purchase CellPrime® rTrypsin and other Merck products with confidence for your research and manufacturing needs through Chemical Express, ensuring access to the highest standard of cell culture solutions.