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FAQ
What is your typical workflow from small scale to pilot scale for a new yeast/bacteria/fungal based project?
  • Optimize process at 1.5L scale to test conditions quickly and inexpensively.
  • Scale up to 15L (glass vessel) or 20L (stainless steel vessel).
  • Finalize conditions and scale to 500L for pilot development, validation, or regulatory data.
  • Optional 1500L scale available for additional sample production.
  • DSP development can iterate at 1.5L or 15L scales to save on consumables.
How long does the entire scale-up process usually take, assuming this is a new strain that hasn't been scaled previously?
  • Approximately 6 weeks if the goal is reaching 500L quickly using existing KPIs.
  • Speed-run includes one 1.5L validation batch and one 15L incremental scaling batch.
  • Approximately 10 to 12 weeks if the goal is full optimization of all process KPIs.
  • Optimization involves three batches at 1.5L (8 fermenters each) and three batches at 15L.
  • Exact timelines fluctuate based on real-time experimental results.
What type of strains do you typically handle? Can you work with BSL-2 organisms?
  • Handle bacteria, yeast, and fungal strains (e.g., E. coli, Pichia pastoris, Trichoderma reesei, Bacillus).
  • Fully integrated fermentation and downstream processing (DSP) capabilities.
  • Certified for BSL-2 work in a dedicated bench-scale lab.
  • Regularly execute 1.5L to 15L fermentation runs for BSL-2 organisms.
Are you equipped to support fermentation systems that require methanol?
  • Equipped to safely handle methanol-based processes.
  • Capabilities exist at both bench-scale and pilot-scale levels.
  • Methanol-based runs are performed routinely.
What materials, documentation, or strain information are required to initiate a project?
  • Early-stage projects require basic strain characteristics and preliminary process info.
  • Pilot-scale transfers require standard tech transfer packages (SOPs, batch records, parameters).
  • Comfortable operating with limited knowledge due to internal expertise in experimental design.
  • Detailed in-house experimental results help accelerate the onboarding and scaling process.
Do you offer downstream processing (DSP) services such as purification or lyophilization?
  • Comprehensive in-house DSP: cell harvest, lysis, clarification, purification, and concentration.
  • TFF capabilities utilizing all four industrial membranes.
  • Centrifugation and multiple chromatography methods.
  • Drying services including spray drying and freeze drying (lyophilization).
In what formats can you deliver protein and final products?
  • Dried formats: Freeze-dried, spray-dried, or vacuum-dried.
  • Liquid formats: Formulated solutions at specified concentrations and buffer conditions.
  • Custom formats available upon request.
Do you offer activity assays or other analytical services for the proteins produced?
  • Routine protein analytics: SDS-PAGE, Western Blots, and purity assays.
  • Functional testing: Activity assays and content assays.
  • Safety/Regulatory testing: Residual DNA tests.
  • Specialized/Certified analytics provided via third-party partners (Merieux, Eurofins).
Do you follow protocols we provide, or do you also offer process optimization services?
  • Can follow client SOPs as-is for direct execution.
  • Offer active bioprocess optimization with run-by-run feedback.
  • Proposed designs for future experiments based on iterative results.
  • Client retains final approval on all technical directions and experimental designs.
Are there any specific customs or biosafety documents required to send our engineered strains to your site?
  • Typically no special documents required for initial shipment.
  • Established logistics for international shipping (UK, EU, Australia, etc.).
  • USDA/APHIS permit support for regulatory filings and environmental authorizations.
How do you handle each client's confidentiality and IP?
  • All projects onboarded and managed under strict confidentiality.
  • Clients maintain 100% ownership of IP developed during process optimization.
  • Secure management of sensitive strain data and process information.
Do you have GMP capabilities or partners in case these are needed in the future?
  • Partnerships with GMP facilities for process graduation.
  • Assist in designing economical process packages suited for GMP requirements.
  • Transition support from pilot development to certified production.
Do you have the capacity for 1000L or larger fermentation runs? If not, do you collaborate with other providers?
  • In-house capacity up to 1500L with full DSP.
  • Third-party partnerships for large-scale production (e.g., 4x25,000L).
  • Early scheduling and collaboration ensure asset availability for scale-up.
What is your pricing model, and what does day-to-day collaboration look like?
  • Rate sheets provided for each scale and DSP type for flexible asset booking.
  • Whole-package proposals available for fixed-scope deliverables and timelines.
  • Dedicated Program Manager handles scheduling, resources, and reporting.
  • Dedicated Project Lead manages experimental design and technical communication.
What tools do you have in-house for data management and advanced analysis?
  • Proprietary LIMS software to track fermentation and DSP data in a secure database.
  • In-house automation for minute-by-minute recording of DSP operations.
  • Interactive dashboards for data plotting and parameter analysis.
  • AI/ML tools including LLMs for automated fermentation run interpretation and summaries.
How do you improve project KPIs and process scalability through data insights?
  • Proprietary ML platform featuring a 'Ferm Design Co-Pilot'.
  • Optimizes media, induction timing, DO cascade, and feeding strategies.
  • Refines DSP parameters like TFF flow rates and chromatography resins.
  • Uses data-driven insights to maximize project-specific KPIs.

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