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Biocatalyst Production Process Development & Consulting

Biocatalyst Production Process Development & Consulting provides comprehensive support for taking biocatalysts from laboratory discovery to industrial implementation. At Creative Enzymes, our services cover every stage of the biocatalyst lifecycle, including process design, optimization, scale-up, and technology transfer. By integrating upstream and downstream considerations, high-throughput experimentation, and advanced bioprocess engineering, we help clients achieve robust, reproducible, and cost-effective production. Creative Enzymes delivers customized, data-driven solutions that accelerate commercialization, reduce development risks, and ensure scalable production of enzymes, enzyme complexes, and whole-cell biocatalysts across diverse industries.

Female worker operating control panel of the pharmaceutical machine

Background: Bridging Discovery and Industrial Manufacturing

Biocatalysis, based on natural or engineered enzymes and microorganisms, has become a key enabling technology for modern industrial production. Compared with traditional chemical synthesis, biocatalytic processes typically operate under milder temperatures and pressures, use less hazardous reagents, and provide superior chemo-, regio-, and enantioselectivity. These advantages translate into improved sustainability, reduced energy consumption, and enhanced product quality, driving widespread adoption in pharmaceuticals, fine chemicals, food ingredients, agrochemicals, and bio-based materials.

Despite these benefits, converting a functional biocatalyst into a reliable industrial production process remains a complex and multidisciplinary challenge. Laboratory success does not automatically translate to manufacturing feasibility. At larger scales, biological systems are affected by limitations in mass and heat transfer, mixing efficiency, oxygen availability, substrate gradients, and mechanical stress. In parallel, economic factors such as feedstock cost, raw material supply, equipment utilization, and downstream processing efficiency become critical determinants of commercial viability.

A complete biocatalyst production process generally consists of three interconnected stages:

  • Upstream Processing: Medium preparation, sterilization, inoculum development, and aeration strategies.
  • Production Processing: Biocatalytic conversion of substrates into target products, maintaining optimal reaction conditions.
  • Downstream Processing: Recovery, purification, and formulation to meet quality and application requirements.

Each stage must be carefully designed, optimized, and integrated. Process development therefore requires a holistic approach that combines biochemical insight, bioprocess engineering, statistical analysis, and industrial experience. Creative Enzymes provides this integrated capability, enabling clients to bridge the gap between discovery and industrial manufacturing with confidence.

What We Offer: Integrated Biocatalyst Production Consulting

Creative Enzymes delivers a full portfolio of biocatalyst production process development and consulting services, covering the entire manufacturing lifecycle.

Process Strategy and Development Planning

  • Evaluation of biocatalyst properties, production goals, and application requirements.
  • Selection of appropriate production routes, host systems, and process configurations.
  • Early identification of technical and economic risks.

High-Throughput Process Optimization

  • Systematic optimization of cultivation, expression, and reaction conditions.
  • Parallel screening of downstream purification strategies.
  • Application of statistical experimental design to accelerate decision-making.

Biocatalyst Production Process Scale-Up

  • Stepwise scale-up from laboratory to pilot and plant scale.
  • Selection and configuration of suitable bioreactors and operation modes.
  • Adaptation of processes to industrial constraints and production targets.

Process Monitoring and Control Development

  • Design of monitoring strategies for critical parameters such as pH, oxygen, temperature, and substrate concentration.
  • Integration of automation and control systems to ensure reproducibility.

Pilot and Industrial Production Support

  • Execution of pilot-scale fermentation or biocatalysis runs.
  • Validation of process robustness and consistency under scale-relevant conditions.

Technology Transfer and Ongoing Consulting

  • Preparation of technical documentation, SOPs, and training materials.
  • Support for internal manufacturing transfer or collaboration with contract manufacturers.

Specialized Service Areas

Biocatalyst Production Process Optimization focuses on refining upstream and downstream conditions to maximize productivity, stability, and reproducibility of biocatalyst manufacturing. Using high-throughput cultivation systems, statistical experimental design, and advanced analytical tools, this service systematically identifies optimal operating windows for enzyme or whole-cell production. By improving yield, reducing variability, and enhancing process robustness at small and medium scales, optimization lays the technical foundation for successful scale-up and cost-effective industrial implementation.

Biocatalyst Production Process Scale-Up addresses the controlled transition of optimized biocatalytic processes from laboratory or pilot scale to industrial manufacturing. This service focuses on bioreactor selection, process integration, and operational control to maintain biocatalyst activity, product quality, and economic performance at increasing volumes. Through stepwise scaling, pilot validation, and risk-mitigation strategies, scale-up ensures that laboratory-proven processes can be reliably and efficiently deployed in commercial production environments.

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Service Workflow: Structured, Stepwise Development

Workflow of biocatalyst production process development and consulting services

Why Choose Us

Comprehensive Expertise

From biocatalyst discovery to industrial production, all stages covered.

High-Throughput Capabilities

Accelerates optimization while reducing cost and experimental load.

Predictive Scale-Up Models

Reduces risk and improves confidence in industrial-scale performance.

Tailored Solutions

Processes customized to biocatalyst type, host, and commercial objectives.

Pilot and Plant-Scale Experience

Hands-on scale-up capabilities ensure smooth translation from lab to production.

Technology Transfer Support

Detailed documentation and consulting ensure reproducibility and regulatory readiness.

Case Studies: Representative Applications

Case 1: Integrated Process Development for n-Butanol Bioproduction

Driven by environmental and economic pressures, this case study examines the development and consulting framework for sustainable microbial production of n-butanol as a next-generation biofuel. Reviving industrial ABE fermentation requires coordinated biocatalyst, fermentation, and bioprocess engineering to address key bottlenecks, notably product toxicity and low space–time yield. Using quantitative economic and ecological constraints, process intensification strategies were systematically evaluated across multiple scales. A comprehensive literature analysis was visualized through a window-of-operation methodology, enabling objective comparison of fermentation performance. Critical success factors were identified, including high cell density, strain stability, enhanced butanol tolerance, efficient in situ product removal, and low-cost feedstocks, providing practical guidance for end-to-end process development and optimization.

Integration of biocatalyst and process engineering for sustainable and efficient n-butanol productionFigure 1. Window of operation for n-butanol production in continuous, immobilized, and integrated processes. (Köhler et al., 2015)

Case 2: Process Development and Scale-Up of Steroid Hydroxylation Using CYP106A2

This case study highlights the development and scale-up of a whole-cell biocatalytic process using CYP106A2 from Bacillus megaterium for selective steroid hydroxylation. Owing to its broad substrate scope and strong 15β-regio- and stereoselectivity, CYP106A2 is a valuable biocatalyst for producing human drug metabolites. The conversion of cyproterone acetate to its main human metabolite, 15β-hydroxycyproterone acetate, was demonstrated under both in vitro and in vivo conditions. Process intensification focused on increasing substrate loading and overcoming solubility limitations using cyclodextrins. Successful scale-up from shake flasks to bench-top bioreactors achieved 98% conversion and 0.43 g/L product titer, approaching industrial feasibility for green pharmaceutical manufacturing.

Process development for the production of 15β-hydroxycyproterone acetate using Bacillus megaterium expressing CYP106A2 as whole-cell biocatalystFigure 2. Comparison of cyproterone acetate transformation in a bioreactor and shake flask using resting cells. (Kiss et al., 2015)

Frequently Asked Questions (FAQs)

  • Q: What is the difference between process development, optimization, and scale-up?

    A: Process development defines the overall strategy, including upstream, production, and downstream workflows. Optimization improves individual steps for yield, activity, and efficiency. Scale-up transitions the process to larger volumes while maintaining performance and reproducibility.
  • Q: When should consulting services be engaged?

    A: Consulting can start at any stage—from early laboratory development to pilot-scale preparation. Early involvement allows parallel optimization and scale-up planning, reducing risk and accelerating time-to-market.
  • Q: Can you handle both enzyme-based and whole-cell systems?

    A: Yes. We support free enzymes, immobilized enzymes, enzyme complexes, and whole-cell biocatalysts. Production strategies, reactor configurations, and downstream processes are tailored to the specific biological system to ensure robust and scalable performance.
  • Q: How do you manage scale-up risks?

    A: Scale-up risks are managed through stepwise scaling, predictive scale-down models, pilot validation, and continuous monitoring of critical parameters. This approach allows early identification of scale-dependent issues and supports smooth transition to industrial production.
  • Q: What improvements can be expected?

    A: Clients typically achieve higher productivity, improved biocatalyst stability, more consistent product quality, reduced raw material use, and lower operating costs. Optimized scale-up also minimizes unexpected performance losses at larger scales.
  • Q: Are services customizable?

    A: Yes. All projects are fully customized based on the biocatalyst type, host system, production scale, and commercial objectives, ensuring practical and industry-ready solutions.

References:

  1. Kiss FM, Lundemo MT, Zapp J, Woodley JM, Bernhardt R. Process development for the production of 15β-hydroxycyproterone acetate using Bacillus megaterium expressing CYP106A2 as whole-cell biocatalyst. Microb Cell Fact. 2015;14(1):28. doi:10.1186/s12934-015-0210-z
  2. Köhler KAK, Rühl J, Blank LM, Schmid A. Integration of biocatalyst and process engineering for sustainable and efficient n‑butanol production. Engineering in Life Sciences. 2015;15(1):4-19. doi:10.1002/elsc.201400041

For research and industrial use only. Not intended for personal medicinal use. Certain food-grade products are suitable for formulation development in food and related applications.

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For research and industrial use only. Not intended for personal medicinal use. Certain food-grade products are suitable for formulation development in food and related applications.