The information you provide to the chat will be collected and recorded to improve your experience and for quality assurance. Please read our privacy policy to see how we are storing and protecting your data.
How can we help you today?
St. Louis, MO, USA
Home to our premier bioprocessing, biologics development, and clinical manufacturing.
650 batches completed, of which 335 were commercial batches (2018–2024).
Over 25 PPQ batch campaigns have been completed, with 18 PAI/PLIs supported to date since 2007.
Over 133 programs developed, and 165 programs transferred to manufacturing (2018 and 2022)
St. Louis, MO, where biologics innovation starts
Spanning over 525,000 square feet in size, with over 105,000 square feet dedicated to cGMP production, our St. Louis, MO biologics development and manufacturing facility is a Center of Excellence for bioprocessing and single-use technology (S.U.T.), featuring the Bioprocessing Collaboration Center (BCC) and the Thermo Scientific™ HyPerforma™ DynaDrive™ Single-Use Bioreactors (S.U.B.s).
Here our experts have access to high capital equipment and resources, enabling them to create customized or optimized process development and scale-up techniques for development of bispecific, Fc-fusion, IgG1, IgG4, and various other complex protein-based biologics.
Capabilities and strategies designed for high-quality and timely production
Significant investment in multiple high throughput systems provides accelerated and robust development and manufacturing. The site uses Beacon™ system for cell line development, Ambr™ 250 systems for final clone and upstream process development, Tecan™ systems for sample preparation and resin screening for downstream development, the Prometheus system for liquid formulation screening and development, in-line conditioning/dilution (ILC/ILD) skid for buffer preparation, and multi-attribute modeling (MAM) for analytical characterization.
Comprehensive CDMO services include:
Cell line development
- Client cell line or CHO-K1 GS knockdown cell line
- AI/ML for vector construction and optimization
- Transposase-based technology for improved gene integration
Process development
- Upstream process development
- Downstream process development
- Platforms to manage multiple projects simultaneously that are tailored to fit various cell lines and molecules, as well as custom development services to meet Phase I to commercialization demands.
Analytical and liquid formulation development
- Robust in-house analytics for quality control (QC), quality assurance (QA), and analytical formulation sciences (AFS), ensuring rigorous testing and compliance.
Cell banking
- The St. Louis facility manufactures all cGMP cell banks on behalf of the biologics network using automated fillers, with over 35 banks and 8,900 vials manufactured since 2024.
Commercialization
- Robust process control strategy, including CMC and regulatory supported process characterization (PC) and and process validation (PV) risk assessments and experimental testing design and data analysis.
- Single-use technology (S.U.T.), featuring the DynaDrive single-use bioreactor (S.U.B.) ranging from scales of 50 L up to 5,000 L. The flexibility inherent to this technology enables us to quickly expand capacity by duplexing S.U.B.s.
- Over 35,000 L of production capacity available based on client need
Built to grow with you—recent investments in capacity to meet market demands
$82.5 million expansion (2021) to enhanced production capacity with the addition of two manufacturing suites and $15 million in updated equipment, supporting 5,000 L processing scale. The expansion more than doubled the site's overall production capacity.
58,000 square foot expansion (2023) for further increased manufacturing capacity, facilitated by state and local tax incentives.
Regulatory excellence, built into every batch
Our proven regulatory track record, having been in compliant for all audits conducted by health authorities across the globe, including but not limited to the US FDA, EMA, PMDA, EAUA, make us a well-known and trusted partner, whether you are a small and emerging biotech company just getting started or a well-resourced biopharma company seeking extended lab space.
See you in St. Louis
To learn more, download our fact sheet and visitor guide.
For a tour of this state-of-the-art facility, request a site tour.