Enzyme Formulation & Stabilization Services

CD Biosynsis offers comprehensive Enzyme Formulation and Stabilization services to address the critical challenges of enzyme stability, operational lifespan, and functional performance. Enzyme stability is paramount for the cost-efficiency of industrial biocatalysis and the therapeutic efficacy of enzyme-based drugs. Our services integrate three core strategies: physical stabilization (Immobilization), chemical stabilization (Modification/PEGylation), and environmental stabilization (Formulation). By utilizing a modular approach, we can tailor the stabilization solution—whether it's developing a robust lyophilized powder, creating a reusable immobilized biocatalyst, or extending circulating half-life via chemical modification—to meet the precise demands of your application, guaranteeing long-term activity and reliability.

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The Comprehensive Strategy for Enzyme Stability

Enzyme degradation is complex, involving unfolding (thermal stress), aggregation (shear/concentration stress), and chemical degradation (oxidation/hydrolysis). Our stabilization strategy is holistic: 1) Immobilization anchors the enzyme to a solid support, enhancing its structural rigidity and allowing for repeated use in reactors. 2) Chemical Modification (like PEGylation) alters the enzyme's surface properties to protect it from proteases and reduce immunogenicity. 3) Formulation identifies optimal excipients and processing conditions (e.g., lyophilization cycle) to protect the enzyme during storage and shipping. We employ advanced analytical techniques, including accelerated stability testing and biophysical characterization (DSF, CD), to quantify stability improvements and provide data suitable for regulatory submission.

Available Enzyme Stabilization Modules

Physical Stabilization (Immobilization) Chemical Stabilization (Modification) Environmental Stabilization (Formulation)

Module 1: Enzyme Immobilization Services

Enhancing operational stability and reusability for biocatalysis:

Enzyme Immobilization Services

Tailored immobilization strategies (Covalent, Entrapment, CLEAs) on carriers like magnetic beads or resins to increase thermal stability and achieve high operational cycles.

Module 2: Enzyme Chemical Modification Services

Introducing new functionalities and extending therapeutic half-life:

Enzyme Chemical Modification Services

Precise chemical conjugation, including PEGylation for pharmacokinetics improvement, and fluorescent/biotin labeling for diagnostics, with confirmed site specificity and activity retention.

Module 3: Enzyme Formulation Development Services

Maximizing shelf-life and ensuring product integrity during storage:

Enzyme Formulation Development Services

Systematic screening of excipients (stabilizers, buffers) and optimization of final product formats (liquid, lyophilized powder) to guarantee long-term storage stability.

Comprehensive Stabilization Workflow

A structured approach to selecting and optimizing the best stabilization strategy.

Initial Stability Assessment

Strategy Selection & Optimization

Process Lock & Scale-Up

Full Characterization & Delivery

Baseline QC: Determine the purity and specific activity of the starting enzyme.

Stress Profiling: Identify the enzyme's main degradation pathway (e.g., thermal denaturation, aggregation) using accelerated testing.

Method Screening: Test pilot runs of the chosen strategy (e.g., test 5 immobilization carriers, 3 PEG sizes, or 20 liquid formulations).

Parameter Optimization: Fine-tune the protocol (e.g., covalent linkage chemistry, excipient ratios, freeze-drying cycle) for maximum activity retention.

Final Protocol: Lock the optimal stabilization procedure (formulation SOP or immobilization protocol).

Bulk Preparation: Produce the required quantity of stabilized enzyme/biocatalyst under the finalized protocol.

Activity Assurance: Verify retained activity, purity, and functional integrity post-stabilization.
Long-Term Data: Initiate real-time and accelerated stability studies to predict and confirm shelf-life.
Documentation: Provide complete CoA, SOPs, and stability data package for regulatory use.

Reliability, Longevity, and Versatility

Integrated Expertise

Combines molecular, chemical, and physical stabilization methods for comprehensive product robustness.

Guaranteed Longevity

Achieve multi-year shelf-life for formulated products and high reuse cycles for immobilized biocatalysts.

Application-Specific Optimization

Solutions are tailored, whether the goal is thermal stability (industrial) or reduced immunogenicity (therapeutic).

Regulatory-Ready Data

Provision of robust, systematic stability data (real-time and accelerated) for easy regulatory filing.

Client Testimonials on Enzyme Formulation & Stabilization

"The combination of their specialized formulation and PEGylation services allowed us to develop a clinical candidate with an optimal half-life and exceptional thermal stability."

Dr. Wei Zhang, Therapeutic Enzyme Program Director

"We used their immobilization service for our lipase. The resulting biocatalyst retained 95% activity after 50 cycles, completely revolutionizing our continuous flow process economics."

Ms. Nicole Dubois, Industrial Biotechnology Manager

"The lyophilized formulation they developed was incredibly robust, guaranteeing product integrity for over two years, which solved our complex global distribution challenges."

Mr. Omar Khan, Global Logistics and R&D Lead

FAQs about Enzyme Formulation & Stabilization Services

Still have questions?

What is the primary benefit of chemical modification over formulation?

Formulation protects the enzyme during storage (passive protection). Chemical modification (e.g., PEGylation) offers active protection by altering the enzyme's properties to survive harsh operational environments, such as high temperatures or the immune system in vivo.

Can I combine immobilization and formulation development?

Yes. After immobilizing the enzyme onto a carrier (making it a heterogeneous catalyst), we can further optimize its storage stability by formulating the final solid biocatalyst product using specific stabilizers, moisture control, and packaging to maintain long-term activity.

What kind of data do you provide for stability assessment?

We provide full analytical reports including residual activity (functional assay), purity (SEC-HPLC/SDS-PAGE), and biophysical data (DSF/CD) at multiple time points under accelerated and real-time storage conditions, along with predicted shelf-life models.

Which service should I choose if my enzyme is for therapeutic use?

Typically, therapeutic enzymes require both Chemical Modification (PEGylation) to improve pharmacokinetics and reduce immunogenicity, and Formulation Development to ensure the final liquid or lyophilized drug product has a guaranteed long-term shelf-life.

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.