Elevate your manufacturing with GMP-Grade enzymes, revolutionizing therapeutic innovation through uncompromising quality.
→ Large-scale GMP-Grade recombinant proteins from our various size fermentors designed to give various yields based on your needs
→ Strict compliance with cGMP regulations
→ Advanced and comprehensive analysis and testing equipment to ensure comprehensive quality release testing
ISO13485:2016 certification is an internationally recognized standard that sets out the requirements for a quality management system that ensures companies adhere to stringent quality control measures, regulatory compliance, and risk management practices throughout the entire product lifecycle. Our company has obtained ISO13485:2016 certification to demonstrate our commitment to producing safe, reliable, and high-quality proteins and enzymes.
Approval ID: 00034327
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.
Unlock the potential of your clinical and commercial manufacturing endeavors with our GMP-Grade enzymes. From mRNA enzymes and CRISPR proteins to our MaxNuclease endonuclease, our portfolio covers ancillary materials crucial for gene-engineered products, mRNA therapies, and viral vector production.
Utilize our affordable research-grade enzymes during preclinical stages to simplify your process development efforts. With the same purity and performance as GMP-Grade, you will be able to seamlessly transition to clinical manufacturing, while ensuring stability, safety, potency, and purity in your final biologics.
Looking to accelerate your research with reliable, high-quality enzymes? Our custom GMP-grade enzyme production service is tailored to meet your specific needs, providing you with top-tier enzymes for your clinical and commercial manufacturing. Whether you require bulk quantities or hard-to-find enzymes, we've got you covered.
Explore our commitment to quality and process improvement.
The process is continuously improved and optimized to become more rational, stable and feasible.
The key parameters in the production process are strictly controlled to ensure consistency of products between batches.
Cell strains are strictly controlled, divided into Master Cell Bank (MCB) and Working Cell Bank (WCB).
The analysis method is verified/confirmed by the system to ensure the validity and repeatability of the results.
Perform QC testing and release in all directions from central control samples, raw solutions, semi-finished products, and finished products.
Continuously monitor batch-to-batch differences to ensure batch-to-batch consistency.
Continuous research on product stability, including influencing factors, tests, accelerated tests, long-term stability studies.
The production process does not use raw and auxiliary materials containing animal sources, equipment, and facilities.
→ Datasheet
→ CoA
→ CoO
→ MSDS
→ Melamine Statement
→ TSE/BSE Statement
→ Nitrosamine Statement
→ DMF Filing
Our document management system can also provide accurate and traceable Batch Production Records and Batch Inspection Records.
Our stability research includes high temperature test, light test, repeated freeze-thaw test, simulated transportation test, accelerated stability test, inter-batch stability study, long-term stability study, etc., to ensure the stability of the product in an all-around way.
Activity
Long-term stability testing (0-18 months) of three batches of Cas9 nuclease was performed using in vitro cleavage activity. Results demonstrate Cas9 nuclease has good long-term stability and batch-to-batch consistency.
Purity
Long-term stability testing (0-18 months) of three batches of Cas9 nuclease was performed using SEC-HPLC. Results demonstrate the purity of Cas9 nuclease has good long-term stability and batch-to-batch consistency.
Freeze/Thaws
Accelerated stability testing of MaxNuclease over 12 freeze/thaw cycles between -80C/4C and -20C/25C. Results demonstrate MaxNuclease has consistent activity up to 12 freeze/thaw cycles.
Streamline your operations, ensure consistent product quality, and achieve regulatory compliance with our robust quality management system.
Organization Chart, Key Personnel Management, Occupational Exposure Control, Training Management
Clean Facility Environment, Installation Qualification, Instrument Operation/Cleaning/Maintenance, Equipment Calibration & Verification, Equipment Lifespan Record System
Supplier Evaluation and Approval, Equipment Acceptance, Equipment Distribution, Expiration & Replacement
Colinear Production Management, Prevention of cross-contamination, Error Management, Process Validation, Cleaning Validation
Analytical Method Validation, Instrument Validation/Maintenance, Sampling of Production Runs for QC Testing, Retention of Samples for Record Keeping, Sample Stability Investigation, Out of Specification (OOS) Management, Data Management, Standard and Reference Substance Management
Change Control, Deviation Management, Product Complaint, Quality Review, Product Recall, Quality Risk Management
Under the reasonable requirements of customer product declaration and supplier audit, KACTUS can provide bacteria identification and passage stability test reports, inspection method verification, process verification, and regulatory information related to FDA DMF filings, where applicable.
Quality inspection tasks of control sample
Concentration, Identity, Endotoxin
Issue central control sample report
Review & approve report
Quality inspection tasks for raw material
Concentration, Identity, Purity, Endotoxin, HCD Residue, HCP Residue
Issue raw material product report
Review & approve report
Dilute product stock solution
Semi-finished product
Quality inspection tasks of diluted product
Concentration
Issue semi-finished product report
Review & approve report
Aliquot finished product
Issue finished product report
Review & approve report
Release finished product
Ongoing stability testing
Long-term & accelerated stability testing
GMP-Grade & GMP-Ready Enzymes
