Phase-appropriate development, tailored to your biologic
Every biologics project carries unique requirements, and a process that fits early development rarely fits commercial supply. We prioritize phase-appropriate strategies that stay flexible and scalable, so your process keeps pace with your needs at every stage. We meet you wherever you are: building new processes, strengthening existing ones, and optimizing for yield, cost, and regulatory readiness.
Upstream process development
Inconsistent fermentation and a heavy impurity load early on make everything downstream harder. We solve this by developing robust fermentation processes that deliver sustainable, reproducible yields and scale reliably while meeting regulatory expectations. By keeping fermentation and harvest conditions controlled, we minimize the impurities carried into purification — giving your final product a high-quality foundation and an upstream process that supports both clinical trials and commercial supply.
We offer:
- Process screening and optimization
- Process verification
- Engineering runs
- Harvest and clarification development
- Filter screening
- Manufacturing of R&D-grade material
Downstream process development
Purification that is over-complicated or poorly matched to your upstream process drives up cost and risk. We help you avoid that by developing scalable, effective downstream processes built on the best available technology. We optimize yields while achieving high clearance of impurities, and we align every step with your upstream process for a seamless progression. We aim for purification that is simple and robust — using the minimum number of unit operations to keep your process economically feasible at scale.
We offer:
- Resin screening
- Buffer optimization
- Chromatography development
- Ultrafiltration and diafiltration (UF/DF) screening and optimization
- Refolding development
Common challenges we help you solve
- Low or inconsistent yields: we screen and optimize conditions to raise yields and make them reproducible
- Impurities reaching purification: we control fermentation and harvest to reduce the impurity load early
- Processes that don’t scale: we design for scalability from the start, so what works in development holds at commercial volume
- Rising cost of goods: we keep purification lean and robust to protect your economics
- Regulatory uncertainty: we build phase-appropriate, compliant processes aligned with regulatory expectations
Frequently asked questions
Yes. We build new processes from scratch and refine existing ones to raise yields, improve robustness, and strengthen regulatory compliance.
Yes. We deliver phase-appropriate development that scales from early clinical material through to commercial manufacturing.
Yes. Whether standalone or in-line with manufacturing, we support your process needs from start to finish.
