Validate AI-designed enzymes and engineered strains at production scale. Our pilot facilities bridge computational predictions and real-world biomanufacturing, providing the wet-lab verification needed to confirm that AI-generated designs perform as expected under industrial fermentation and biocatalysis conditions.
AI-driven enzyme design and strain engineering produce promising candidates in silico, but computational predictions must be validated through real-world fermentation and production. Our pilot scale facilities provide the critical wet-lab bridge — confirming that AI-designed proteins express correctly, maintain activity, and achieve target yields at industrially relevant scales.
We optimize fermentation conditions, biocatalysis parameters, and downstream processing to maximize yield, purity, and cost-effectiveness at pilot scale.
Our bioreactor fleet spans multiple volume scales, enabling systematic scale-up studies with rigorous monitoring of critical process parameters and quality attributes at each transition point.
Every batch comes with comprehensive Certificate of Analysis (CoA), including purity, activity, identity, and safety testing to meet regulatory requirements.
Every AI-designed enzyme or engineered strain must prove itself in the bioreactor. We apply Quality by Design (QbD) principles to systematically validate computational predictions under real-world production conditions.
Systematic parameter optimization
We define the design space for critical process parameters (CPPs) including temperature, pH, dissolved oxygen, agitation rate, and feeding strategies. Multivariate analysis identifies robust operating ranges that ensure consistent product quality.
Comprehensive product characterization
We establish and monitor critical quality attributes (CQAs) including protein purity, activity, aggregation, glycosylation pattern, and host cell proteinresidue. Real-time monitoring ensures consistent product quality across batches.
Physics-based scale translation
We apply engineering principles for reliable scale-up: constant volumetric oxygen transfer coefficient (kLa), constant power per unit volume (P/V), and similar mixing times. This ensures metabolic and process equivalence between scales.
Documentation and traceability
Our quality management system ensures complete documentation trail from raw materials to final product release. We maintain batch records, deviation reports, and change control documentation suitable for IND/NDA submissions.
End-to-end services to validate and scale AI-designed enzymes, proteins, and engineered strains
From shake flask optimization to stirred-tank bioreactor scale-up, we handle fed-batch, continuous, and perfusion cultures in bacterial, yeast, and fungal systems.
High-yield enzyme production for biocatalysis applications. We optimize expression systems, fermentation strategies, and downstream processing for maximum catalytic output.
Integrated purification suite for protein and metabolite recovery. Our DSP team develops and implements cost-effective purification strategies optimized for your product.
Our pilot production facilities are equipped with advanced bioreactors, purification systems, and analytical instruments to handle diverse production requirements.
Stirred-tank bioreactors in multiple volume scales with full monitoring and control systems for systematic scale-up studies.
AKTA Pure and Pilot chromatography systems for purification at laboratory through pilot scales.
Complete QC/QA laboratory for in-process and release testing with validated methods.
BSL-2 rated production areas for contained organisms and processes.
We combine deep process expertise with flexible facilities to deliver reliable pilot scale production.
Pre-validated process platforms accelerate project initiation. Our standardized production modules reduce development timelines while maintaining rigorous quality standards throughout scale-up.
Modular facility design allows rapid configuration changes. Run multiple projects in parallel with dedicated bioreactor trains.
Quality by Design methodology ensures robust, reproducible processes. Real-time monitoring and automated control systems maintain consistency.
Documentation packages suitable for IND/NDA submissions. We support technology transfer to CMO partners with comprehensive process knowledge packages.
Our pilot production services are designed to confirm that computationally generated candidates deliver consistent performance when moved from bench to bioreactor.
Confirm that AI-predicted enzyme variants maintain their catalytic advantages when produced at pilot scale. We evaluate expression yield, specific activity, and stability under fermentation conditions to verify computational predictions.
Validate that AI-optimized microbial strains maintain their improved production phenotypes during scale-up from shake flask to stirred-tank bioreactor. Process parameters are systematically optimized at each scale transition.
Confirm that AI-designed biocatalytic cascades and whole-cell systems function reliably at pilot scale. Our team verifies conversion efficiency, enantioselectivity, and co-factor requirements under manufacturing-relevant conditions.
Scale up production of AI-designed recombinant proteins — including therapeutic candidates and industrial enzymes — with validated fermentation protocols and downstream purification processes.
Validate AI-optimized metabolic pathways by producing target metabolites at pilot scale. Our facilities support both primary and secondary metabolite production using engineered microbial hosts.
Generate comprehensive process knowledge packages suitable for technology transfer to GMP manufacturing facilities. Documentation supports regulatory submissions and commercial scale-up decisions.
Our systematic approach ensures smooth transitions between project phases
Technical review of your process, target specifications, and timeline requirements. Initial feasibility assessment and scope definition.
Process optimization at laboratory scale. DoE studies for parameter optimization. Small-scale runs to establish performance baselines.
Systematic scale-up to pilot reactors. Real-time monitoring of critical parameters. In-process quality control testing.
Downstream processing and purification. Final quality release testing. Documentation package and regulatory support.
Common questions about our pilot scale production services
We offer pilot scale production across a range of bioreactor volumes, from laboratory-scale development reactors to industrial pilot vessels. Batch sizes are determined based on your target product quantity and process requirements. Multiple parallel runs are available for projects requiring larger volumes.
We use Quality by Design (QbD) principles to develop scalable processes. This includes reactor geometry similarity, impeller power input normalization, and mass transfer coefficient (kLa) matching between scales. We characterize critical process parameters (CPPs) and critical quality attributes (CQAs) at each scale.
We have experience with E. coli, Pichia pastoris, Saccharomyces cerevisiae, Bacillus subtilis, and various filamentous fungi. For metabolites, we work with engineered strains in all these hosts plus specialized producers for secondary metabolites.
Every batch undergoes comprehensive quality control including purity analysis (SDS-PAGE, HPLC), activity assays, endotoxin testing (for microbial products), sterility testing, and residual host cell protein/DNA analysis. We provide Certificates of Analysis (CoA) with each shipment.
Yes. Our pilot facilities include Biosafety Level 2 (BSL-2) containment areas suitable for organisms requiring biosafety containment. We can also handle certain BSL-2+ organisms with appropriate approvals and specialized equipment.
Peer-reviewed research supporting AI-driven fermentation optimization and scale-up
Du YH, Wang M, Li J et al. Optimization and Scale-Up of Fermentation Processes Driven by Models. Bioengineering. 2022;9(9):473.
Shi Z, Liu P, Liao X, Mao Z et al. Data-Driven Synthetic Cell Factories Development for Industrial Biomanufacturing. BioDesign Research. 2022;2022:9898461.
Contact our team to discuss your pilot scale production requirements. We'll provide a detailed project plan and quotation promptly after reviewing your specifications.
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