Upstream & Downstream Development
Optimization of microbial fermentation, cell culture, and purification processes (e.g., depth filtration, chromatography) to increase yield and product quality.
Develop and optimize synthetic routes as your program moves from laboratory research toward larger-scale production.
The science
We transform laboratory-scale chemistry into robust, reproducible processes for material supply, delivering data-driven solutions that keep your process performing from discovery through manufacture. Process development and scale-up are essential to a competitive commercial product. Our scientists conduct rapid process development, optimize reaction conditions, and scale up materials for preclinical studies or large-scale manufacturing, taking a pragmatic approach even on the most challenging projects. We assess route feasibility, risk, and cost to identify the most efficient and scalable pathway for your molecule.
How we can help
Explore the services and methods available for your project.
Optimization of microbial fermentation, cell culture, and purification processes (e.g., depth filtration, chromatography) to increase yield and product quality.
Pre-formulation studies, solubility enhancement, and specialized technology application.
Using experimental design techniques (DoE) to identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to ensure robust performance.
How a project runs
4 stages, with a clear outcome at each step.
Assessing synthetic route feasibility, risk, cost, and evaluating target molecule pathways.
Outcome: Route Feasibility
Optimizing reaction conditions via statistical Design of Experiments (DoE) and parallel equipment screening.
Outcome: DoE Optimization
Optimizing microbial fermentation, cell culture, filtration/chromatography, and identifying CPPs/CQAs.
Outcome: QbD Process Parameters
Establishing in-process analytical methods, conducting Process Safety Assessment, and scaling up materials for clinical trials.
Outcome: Clinical Batch Scale-Up
Explore in detail
Open a section to explore our full service scope and instrumentation.
Synthetic route evaluation and development of new methodologies for target molecules to identify the most scalable pathway.
Optimization of reaction conditions to reduce cost & maximize throughput by classical methods or statistical design of experiments (DoE).
Ability to perform synthetic work under extreme cryogenic conditions (-78 °C) or high pressures (>100 psi).
Development of reliable in-process testing methods for intermediates/APIs, rapid parallel screening, and comprehensive Process Safety Assessments.
Let’s work together
Talk with our scientific team about your requirements,
technical feasibility, and timelines.