Integrated Enzyme Production & Formulation Services

CD Biosynsis provides fully integrated Enzyme Production and Formulation services, offering a complete solution from initial gene to final commercial product. Our platform combines high-yield Custom Enzyme Production with specialized Formulation and Stabilization expertise, ensuring that your target enzyme is not only produced efficiently but is also delivered with maximum functional stability and shelf-life. We seamlessly handle every stage: expression system selection, fermentation and purification optimization, advanced stabilization (immobilization, chemical modification), and final scale-up to meet industrial and pharmaceutical demands. This comprehensive approach guarantees product quality, process scalability, and reliability for therapeutic, diagnostic, and biocatalysis applications.

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Full Lifecycle Management: From Bench to Bulk

Successful commercialization of an enzyme product relies on three pillars: high yield, structural integrity, and long-term stability. Our integrated pipeline addresses these needs sequentially. We start with Custom Enzyme Production to optimize yield and purity at the pilot scale. We then apply Formulation & Stabilization techniques (e.g., lyophilization and PEGylation) to guarantee the enzyme's function over time and across varying conditions. Finally, we implement Scale-Up Production methodologies to ensure the entire optimized process is robust, cost-effective, and fully documented for large-scale manufacturing and regulatory submission. This holistic service minimizes the risk and complexity traditionally associated with transitioning novel enzymes to market.

Available Enzyme Production and Formulation Modules

Custom Enzyme Production Formulation & Stabilization Process Scale-Up & Validation

Module 1: Custom Enzyme Production Services

High-purity expression and purification for research and pilot studies:

Custom Enzyme Production Services

Tailored services covering gene synthesis, host selection (Microbial, Yeast, Mammalian), and multi-step chromatography optimization to deliver high-purity, active enzyme in milligram to gram quantities.

Module 2: Enzyme Formulation & Stabilization Services

Enhancing activity retention, shelf-life, and operational performance:

Enzyme Formulation & Stabilization Services

Includes formulation development (lyophilization, liquid stock), chemical modification (PEGylation, labeling), and immobilization strategies (CLEAs, carriers) to maximize stability.

Module 3: Enzyme Scale-Up Production Services

Transitioning optimized processes to industrial and cGMP-ready manufacturing:

Enzyme Scale-Up Production Services

Process validation, large-scale fermentation optimization (50L-1000L+), downstream process redesign, and comprehensive Technology Transfer Package generation for commercial readiness.

Integrated Production-to-Product Pipeline

A seamless, quality-controlled process from gene design to final stabilized product.

Target Selection & Pilot Production

Purity & Stability Optimization

Process Scale-Up Validation

Final QC, Documentation & Delivery

Gene Cloning & Host Selection: Determine the optimal expression system for functional activity.

Bench-Scale Production: Deliver initial high-purity enzyme batch for functional and stability assessment.

Stabilization Strategy: Choose and optimize Immobilization, Modification (e.g., PEGylation), or Formulation (e.g., lyophilization).

Stability Testing: Perform accelerated and real-time stability studies on the formulated or stabilized product.

Fermentation Validation: Optimize USP (media, feeding) for large-scale bioreactor performance.

DSP Validation: Adapt purification methods (chromatography) for high-flow, high-volume production with maximized yield.

Commercial Production: Execute production runs according to the Master Batch Record.
Regulatory Package: Finalize the Technology Transfer Package, including all SOPs and validation data.
Delivery: Ship the final high-quality, stabilized enzyme product for commercial use.

Single Partner for End-to-End Enzyme Commercialization

Fully Integrated Solution

Eliminates hand-off risks between development, stabilization, and scale-up partners.

Guaranteed Stability & Shelf-Life

Proactive stabilization strategies ensure the final product meets commercial storage and operational needs.

Cost-Efficiency & Yield

Optimization of media, process conditions, and DSP leads to lower Cost of Goods (COG) at scale.

Regulatory Documentation

Provision of cGMP-ready SOPs and robust validation data for streamlined regulatory submission.

Client Testimonials on Integrated Enzyme Services

"The combination of their expression, PEGylation, and lyophilization services delivered a therapeutic enzyme ready for pre-clinical trials with guaranteed 24-month stability."

Dr. Emily Carter, Chief Technology Officer

"Using a single partner for the entire process—from small-scale purification to 500L scale-up—significantly cut down our development timeline and validation costs."

Mr. David Lopez, VP of Biomanufacturing

"The technology transfer package they generated was incredibly comprehensive, allowing our contract manufacturer to execute the first cGMP batch flawlessly."

Ms. Naomi Kishimoto, Program Management Lead

FAQs about Enzyme Production & Formulation Services

Still have questions?

Why use an integrated service instead of separate vendors?

An integrated service ensures seamless data flow and process compatibility between production, stabilization, and scale-up steps. This minimizes technology transfer friction, reduces risk of process failure at scale, and shortens the overall time-to-market.

Do you offer cGMP-compliant manufacturing?

We specialize in developing and validating processes that are fully cGMP-ready, providing the necessary documentation (SOPs, Master Batch Records) and quality systems for technology transfer to a client's cGMP manufacturing facility or a specialized CDMO.

How do you handle difficult-to-express or toxic enzymes?

We use specialized hosts (e.g., specific yeast strains, mammalian cells) and process controls (e.g., low-temperature induction, inclusion body processing, fed-batch strategies) to maximize solubility, minimize toxicity to the host, and achieve high functional yield.

Is enzyme immobilization covered under this integrated service?

Yes, immobilization is a key component of our Enzyme Formulation & Stabilization Services module, specifically targeting industrial enzymes that require reusability and operational stability in continuous biocatalytic reactors.

How much does Metabolic Engineering services cost?

The cost of Metabolic Engineering services depends on the project scope, complexity of the target compound, the host organism chosen, and the required yield optimization. We provide customized quotes after a detailed discussion of your specific research objectives.

Do your engineered strains meet regulatory standards?

We adhere to high quality control standards in all strain construction and optimization processes. While we do not handle final regulatory approval, our detailed documentation and compliance with best laboratory practices ensure your engineered strains are prepared for necessary regulatory filings (e.g., GRAS, FDA).

What to look for when selecting the best gene editing service?

We provide various gene editing services such as CRISPR-sgRNA library generation, stable transformation cell line generation, gene knockout cell line generation, and gene point mutation cell line generation. Users are free to select the type of service that suits their research.

Does gene editing allow customisability?

Yes, we offer very customised gene editing solutions such as AAV vector capsid directed evolution, mRNA vector gene delivery, library creation, promoter evolution and screening, etc.

What is the process for keeping data private and confidential?

We adhere to the data privacy policy completely, and all customer data and experimental data are kept confidential.