Enzyme Formulation Development Services

CD Biosynsis offers expert Enzyme Formulation Development services to maximize the stability, shelf-life, and functional performance of high-value enzymes for various applications, including therapeutics, diagnostics, and industrial biocatalysis. A poorly formulated enzyme can rapidly lose activity, jeopardizing the success of downstream products. Our service provides systematic screening of excipients (stabilizers, buffers, cryoprotectants) to identify the optimal matrix for liquid, lyophilized (freeze-dried), or spray-dried enzyme products. We specialize in developing robust formulations that withstand storage, shipping, and operational conditions, providing long-term activity assurance and simplifying regulatory approval pathways.

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Optimizing Enzyme Stability and Shelf-Life

Enzyme formulation is a multi-dimensional challenge involving minimizing denaturation caused by temperature, shear, pH, and chemical degradation. We utilize Design of Experiments (DoE) methodology to efficiently screen dozens of excipient combinations, including sugars, polyols, amino acids, and non-ionic detergents, against various stress conditions (e.g., accelerated stability testing). For solid formulations (lyophilization), we optimize the cycle parameters and bulk agent ratios (e.g., sucrose/trehalose) to ensure cake integrity and maximum residual activity upon reconstitution. The final product is a stable, ready-to-use enzyme preparation with a confirmed long-term storage guarantee, essential for quality control and commercial viability.

Customizable Enzyme Formulation Modules

Desired Formulation Type Stabilizer and Excipient Screening Long-Term Stability Assurance

Choose the Required Formulation Type

Select the final presentation format required for your specific application and logistics:

Check the box next to the final Formulation Type you require:

Liquid Solution (Ready-to-Use)

Lyophilized Powder (Freeze-Dried)

Spray-Dried Powder

High-Concentration Stock Solution

Cryopreservation Formulation

Microencapsulation (for controlled release)

Pre-Filled Syringe Compatibility

Buffer Exchange and Desalting

Stabilizer and Excipient Screening

Select the essential excipient types to optimize formulation robustness:

Select the types of Excipient Screening needed:

Thermal Stabilizers (Sugars/Polyols)

Cryoprotectants (for freezing)

Non-ionic Detergents (for solubility)

Antioxidants and Chelating Agents

Buffer System & pH Optimization

Amino Acid/Protein Stabilizers

Lyophilization Cycle Optimization

High-Throughput Stability Screening (HTS)

Stability Testing and Characterization

Select the necessary long-term testing and analytical methods:

Accelerated Stability Testing

Short-term testing under high stress (high temperature) to predict long-term shelf life.

Real-Time Stability Study

Tracking activity loss over long periods (e.g., 6, 12, 24 months) under recommended storage conditions.

Biophysical Characterization (DSF, CD)

Using techniques like Differential Scanning Fluorimetry to measure thermal denaturation temperature (Tm) in various formulations.

Enzyme Formulation Development Workflow

A systematic process for robust stability optimization.

Pre-Formulation & QC

Excipient Screening (HTS)

Lead Formulation Optimization

Stability Testing & Documentation

Initial QC: Verify purity, activity, and concentration of the bulk enzyme stock.

Stress Testing: Assess the enzyme's intrinsic stability against temperature, shear, and pH extremes to define the instability profile.

DoE Setup: Design a High-Throughput Screening (HTS) matrix testing combinations of buffers, salts, and stabilizers (sugars, amino acids).

Accelerated Stability: Screen the HTS panel under accelerated conditions (e.g., 40°C or freeze-thaw cycles) to identify top lead candidates.

Final Excipient Ratio: Fine-tune the concentration of the lead stabilizers for maximum protective effect.

Process Optimization: Develop the final manufacturing process (e.g., lyophilization cycle, sterile filtration) for the lead formulation.

  • Real-Time Stability: Initiate long-term testing (e.g., 2-year shelf life at 4°C) on the finalized formulation.
  • Biophysical QC: Run Differential Scanning Calorimetry (DSC) or Circular Dichroism (CD) to confirm native structure preservation.
  • Documentation: Provide detailed Formulation SOP, stability data, and recommended storage conditions.

Long-Term Activity Assurance and Reliability

Maximized Shelf-Life

           

Development of formulations that provide 24+ months of stability under intended storage conditions.

Robust Process Development

           

Optimization of solid-state processes (lyophilization, spray drying) for excellent cake appearance and easy reconstitution.

High-Throughput Screening (HTS)

           

Efficient screening of hundreds of excipient combinations using DoE methodology to quickly find the optimal matrix.

Regulatory Support

           

Provision of detailed biophysical and stability data suitable for regulatory filings (IND/NDA).

Client Testimonials on Enzyme Formulation Development

"The lyophilization cycle and excipient screen they performed resulted in a freeze-dried product that maintained 99% activity after six months at room temperature, which was critical for global shipping."

Dr. Sarah Johnson, Pharmaceutical Formulation Lead

"Their accelerated stability testing quickly identified the optimal buffer system and cryoprotectant, preventing activity loss during our large-scale freezing and storage."

Mr. Kevin O'Connell, Bioprocess Optimization Manager

"The detailed biophysical data (DSF) provided clear evidence of how their final liquid formulation protected our enzyme, giving us high confidence in the 18-month shelf-life prediction."

Ms. Lin Mei, Diagnostic R&D Scientist

FAQs about Enzyme Formulation Development Services

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What is lyophilization and why is it used for enzymes?

Lyophilization (freeze-drying) removes water from the enzyme preparation, leaving a dry powder (cake). This process significantly reduces degradation rates, maximizing shelf life, and allows the product to be stored at room temperature or refrigerated, simplifying logistics.

What is the role of excipients in enzyme formulation?

Excipients are inactive substances used to stabilize the enzyme. Common excipients like sucrose and trehalose protect the enzyme structure during freezing or drying (cryo- and lyoprotectants), while buffers control pH, and surfactants prevent aggregation.

How does accelerated stability testing work?

Accelerated stability testing exposes the enzyme formulation to controlled stress conditions (e.g., elevated temperature like 40°C) for a short period (weeks/months). The degradation rate is then used to mathematically predict the enzyme's long-term shelf life at normal storage temperatures (e.g., 4°C).

Do you only offer stability for liquid formulations?

No. We specialize in both liquid formulations (optimizing buffer, pH, and stabilizers) and solid-state formulations, including optimizing the entire lyophilization cycle and excipient blend for a robust, easily reconstituted powder product.

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.

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