Sample testing and/or determination of custom production requirements
GMP-Grade Production
Our line of GMP products are manufactured in our dedicated 100,000 square foot GMP-production facility. This enables us to provide you with routine bulk supply of product as you move from the research stage to commercial manufacturing. We provide comprehensive quality control testing and documents for regulatory filing, including batch production records, auditing trails, etc.
Quality Control & Assurance
→ MES digital production management system
→ Pharmaceutical Class A & C Clean Room
→ Batch Production & Inspection Records
→ Comprehensive Product Release Process
→ Regulatory-guided process validation
You receive scientific support for custom protein modifications to ensure the best configuration for your application
We provide strict quality control specifications to ensure high purity and bioactivity of the product
You receive routine bulk quantities of material as you move from the research stage to clinical or commercial manufacturing
You receive documents such as batch auditing records, equipment certification, etc. to support your regulatory filing
DMF-Approved Products
A DMF (Drug Master File) is a document submitted by a company to the FDA. The document contains detailed information on the entire production process, including product formulations, plant facilities, production processes, and any other procedures involved in this product. DMF filing demonstrates transparency by the company and willingness to work alongside regulations. Additionally, when companies apply for a new product registration with the FDA, using materials with a DMF will shorten the registration time.
mRNA Therapeutics
KACTUS offers a comprehensive selection of GMP-grade enzymes for in vitro transcription and modification of mRNA.
Custom Projects
KACTUS offers custom protein production or modification, at research-grade or GMP-grade. We offer scientific support and design assitance and strict quality control testing.