GMP-Grade Enzyme Production

Elevate your manufacturing with GMP-Grade enzymes, revolutionizing therapeutic innovation through uncompromising quality.


R&D, Production, Quality Control Center


GMP-Grade Manufacturing Site


Fermentor for Production of GMP-Grade Proteins


Employees in R&D and Quality Control

→ 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

500L Liquid Dosing and CIP System

Aseptic Isolator

1000L Fermentation Tank

Chromatography System


ISO13485 Certified

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

FDA Drug Master Files (DMF) Submissions

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 Enzymes, CRISPR Proteins, MaxNuclease

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.

Seamless Transition from Research to GMP

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.

Custom GMP Enzyme Production

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.

Experience Quality: Process Control & Optimization

Explore our commitment to quality and process improvement.

Continuous Process Improvement

The process is continuously improved and optimized to become more rational, stable and feasible. 

Control of Production Variables

The key parameters in the production process are strictly controlled to ensure consistency of products between batches. 

Cell Strain Control

Cell strains are strictly controlled, divided into Master Cell Bank (MCB) and Working Cell Bank (WCB). 

Analytical Method Verification

The analysis method is verified/confirmed by the system to ensure the validity and repeatability of the results. 

Quality Release Testing

Perform QC testing and release in all directions from central control samples, raw solutions, semi-finished products, and finished products. 

Batch-to-Batch Consistency

Continuously monitor batch-to-batch differences to ensure batch-to-batch consistency. 

Stability Testing

Continuous research on product stability, including influencing factors, tests, accelerated tests, long-term stability studies. 

Free from animal-derived materials

The production process does not use raw and auxiliary materials containing animal sources, equipment, and facilities. 

Customizable GMP Documentation Package

→ Datasheet

→ CoA

→ CoO


→ 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.

Stability Testing

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.


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.


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.


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.

Quality Management System

Streamline your operations, ensure consistent product quality, and achieve regulatory compliance with our robust quality management system.

Institutions & Personnal

Organization Chart, Key Personnel Management, Occupational Exposure Control, Training Management

Plant and Facility Equipment

Clean Facility Environment, Installation Qualification, Instrument Operation/Cleaning/Maintenance, Equipment Calibration & Verification, Equipment Lifespan Record System

Material Management

Supplier Evaluation and Approval, Equipment Acceptance, Equipment Distribution, Expiration & Replacement

Production Management

Colinear Production Management, Prevention of cross-contamination, Error Management, Process Validation, Cleaning Validation

Quality Control

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

Quality Assurance

Change Control, Deviation Management, Product Complaint, Quality Review, Product Recall, Quality Risk Management

Comprehensive Documentation System

The Quality Management System (QMS) documentation includes the QMS program overview, guidelines and basic regulations for quality management, and quality system operation. 

Our Specification Program includes expansion instructions and concrete documentation of the quality manual, so that the principled and programmatic requirements in the quality manual can be expanded and implemented as necessary.

Criteria Support Documents includes: Standard Management Procedures (SMP), Quality Standards, Standard Operating Procedures (SOP), Work Instructions (WI), and other supporting documents.

Our Quality Report records the activity status and results of each product, providing evidence that the product meets the quality requirements and the QMS is operating effectively

Support Declaration

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.

Product Release Process

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


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

Find your enzyme

GMP-Grade & GMP-Ready Enzymes

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