FAQ

For a new strain coming out of the screening pipeline, our typical workflow is to optimize a client’s process at the 1.5L scale before scaling to larger fermenters. Doing so lets us test a large number of conditions quickly and inexpensively before scaling up to 15L (glass vessel) or 20L (stainless steel vessel). Similarly, DSP development can start at either the 1.5L or 15L scale, where we can quickly iterate on trials using less expensive consumables than those at the larger scales. 

Once fermentation and DSP conditions are finalized, we scale to 500L for any remaining pilot development/validation, regulatory approval data, and/or sample production as needed. Clients also have the option to run at the 1500L scale for additional sample production.  

If the client’s primary goal is to go to 500L as quickly as possible while running with existing process KPIs, the entire process from start to finish typically takes about six weeks, beginning from when we receive the strain. We run one process validation batch at the 1.5L scale and one incremental scaling batch at the 15L scale to define the process for the 500L.  

If the client’s primary goal is to optimize all process KPIs, we typically spend more time for process improvement runs at the smaller scale, spanning about ten to twelve weeks. The exact timeline will change depending on experimental results, but process optimization usually starts with three batches of 1.5L with eight individual fermenters running in each batch. This is then followed by three batches of 15L to optimize the full fermentation and DSP processes before scaling to 500L.  

We routinely work with bacteria, yeast, and fungal strains, with fully integrated fermentation and downstream processing capabilities. These include E. coli, Pichia pastoris, Trichoderma reesei and spore-forming Bacillus species. 

We can also work with BSL-2 strains. One of our bench scale labs is certified for BSL-2 work, and we regularly run 1.5L to 15L scale fermentation with BSL-2 organisms.  

Yes, our bench-scale and pilot facilities are equipped to safely handle methanol-based processes and do so routinely. 

For early stage projects, we typically only require basic strain characteristics and preliminary process information to onboard at bench scale and initiate process optimization.  

For projects moving directly into pilot scale, we usually request a standard tech transfer package, including existing SOPs, batch records, and defined process parameters. That said, we frequently work with early-stage companies and have expertise in experimental design, so we’re very comfortable operating with limited process knowledge. However, the more information shared, the easier it will be to onboard your project. You may also be able to scale faster if we know more about what experimental results you’ve achieved in-house prior to your tech transfer.  

Yes, we have comprehensive DSP capabilities in-house, including cell harvest, cell lysis, clarification, purification, concentration, and drying. We routinely work with TFF (with all 4 industrial membranes), centrifugation, several chromatography methods, spray drying, and freeze drying, at both bench and pilot scales. For a full overview of our capabilities and available equipment, please visit our Capabilities page.

Final products can be freeze-dried, spray-dried, or vacuum-dried. We can also deliver protein products as a formulated solution at your specified concentration and buffer conditions. Other formats are available upon request.

Yes, we routinely run protein analytics, including SDS-PAGE, Western Blots, activity assays, content assays, purity assays, and residual DNA tests.

For specialized or certified analytics we work with trusted third-party labs such as Merieux and Eurofins through well-established workflows.

We work in close collaboration with you to determine the best approach for your specific process/product during development and scale-up. While we can follow your existing SOPs as-is, our strength lies in bioprocess optimization. If you opt for optimization, we’ll actively provide run-by-run feedback, including proposed designs for future experiments based on previous results. You will always have the opportunity to review and approve each proposed experiment to ensure you’re comfortable with the technical direction at every stage.

Typically, no special documents are required to send engineered strains to our facility. 

We have well-established logistics and custom processes for international strain and sample shipments, which include the UK, France, Germany, Spain, Sweden, Australia, and other countries. We also have established processes with USDA to support regulatory filings, such as APHIS permits and other environment-related import authorizations.

Each client's project is onboarded and managed under complete confidentiality. IP developed and generated from process development and optimization work with us is completely owned by clients.

Yes, we do have GMP facility partners into which we can graduate the developed processes. Pricing varies based on the final tech package and raw materials, but we’ll help you design a well-suited and economical process package to go into GMP facilities.

We have the capacity for up to 1500L with full DSP capabilities, and we partner with third-party facilities for large scale production capacity, including 4x25,000L. Timelines vary based on process readiness and asset availability for both BostonBio and partner facilities. We typically start discussions early for larger scale needs and schedules to allow more time for scale up.

After learning about your technical process and project goals, we will factor in the parameters you would like to test, the types of equipment that are necessary, and the length of run time. We then generate a pricing sheet for each scale (1.5L, 15L, 20L, 500L, and 1500L) and DSP (including centrifuge, filtration, TFF, chromatography, and drying) so that you can book assets on the go for various experimental designs and tests. This enables maximum R&D flexibility while we work as an extension of your lab and pilot.

We also offer a whole-package proposal, where we align and specify the work scope for each scale, including deliverables and timeline.

In operation, each project has a designated Program Manager and Project Lead. The Program Manager oversees the schedule, resources, and project reports to ensure the committed deliverables on time; the Project Lead oversees all experimental designs, batch record approval with clients, concise experiment execution, and close communication and engagement with each client’s technical team while the experiment is ongoing.

We have built our proprietary LIMS software to specifically track all aspects of fermentation, DSP, and bioprocess scale-up. Our LIMS tracks all input design and in-process data, resulting in a secure relational database that allows you to easily query information across all your experimental batch records. We also have a growing suite of in-house automation tools to directly record minute-by-minute run data for DSP operations.

We create dashboards where you can plot all detailed graphs with chosen parameters or stay at dashboard level. Our Project Leads will also provide summary reports, slide decks, and traditional siloed batch records in secure data-transfer platforms.

Our machine-learning team has built AI-guided data intelligence tools to make data analysis a matter of just a few clicks. We utilize trained Large Language Models (LLM) to automatically interpret your fermentation runs and generate summaries upon completion of each experiement.

Our LLM based DSP Summarizer is currently under development and is coming soon. 

Our bioprocess engineering expertise is complemented by our proprietary machine learning platform. We have built a Ferm Design Co-Pilot for our engineers that suggests optimal experimental design according to your needs. It uses a combination of factors to help maximize the KPIs for your fermentation and DSP runs, such as media compositions, concentrations of certain raw materials, induction timing, DO cascade controls, and feeding schemes and strategies, as well as TFF flow rates, membrane materials, and chromatography resins. This Ferm Design Co-Pilot will soon be open to our clients.

Of course, the client will always be the final approver for each experimental design prior to execution.