Transforming Biotherapeutics and Bioprocessing
Production Enhancement - Improved Performance, Increased Product Quality, Reduced Operating Costs
We offer advanced capabilities in the production of biotherapeutics by leveraging our leadership position in science-of-scale process modeling. We provide novel tools and solutions to improve upstream and downstream processes so that our clients can achieve:
- improved performance,
- increased product quality, and
- reduced operating costs.
To drive our clients’ biotherapeutic production to higher levels, Bend Research develops and optimizes pharmaceutical engineering processes and technologies using an approach grounded in engineering fundamentals. Working closely with our clients, we focus on providing the optimal environment for cell lines during each stage of the bioprocess lifecycle. We use novel techniques to ensure key bioprocess values are measured accurately and frequently.
- We implement new methodologies to obtain these improved measurements at key points throughout the bioprocess lifecycle.
- We deploy models that accurately correlate process variables to cell viability and growth.
- We use model-based predictive controls that enable automatic real-time adjustments, providing optimal bioprocess management.
Innovation Across the Drug Development Process Train
Bend Research offers a broad range of tools that can be applied at every stage of development from feasibility evaluation to scale-up and commercialization of products and processes. General bioprocess capabilities include:
- Cell Culture Innovation
- Process Modeling and Applied Mathematics
- Upstream Production Technology
- Downstream Process Development
- cGMP Containment Suite for the Spray-Drying of Biotherapeutics
Upstream Production Technology and Technology Transfer
Our expertise in process and equipment design enable production of batch sizes ranging from 2 to 30 liters onsite to up to 12,000 liters at our clients’ facilities. We leverage tools, models, and know-how to support scale-up efforts at our clients’ facilities, transferring their lab-scale processes to pilot-scale (~5,000 liters) and commercial-scale (~12,000 liters) bioreactors. Through these efforts, we optimize production of target cell lines across multiple scales.
Downstream Process Development
Our proficiency and know-how in managing purification processes allow our clients achieve the highest quality products possible. Our services enable chromatography development and preparation of monoclonal antibody (mAb) samples for further downstream development. Bend Research specializes in filtration studies that ultimately deliver solutions that reduce capital and operating costs and optimize Productivity.
Modeling at Multiple Scales
Computational modeling allows clients to reliably replicate optimal process conditions during scale-up, maintaining maximum performance in upstream and downstream processing. Our in-house capabilities include multizonal computational fluid dynamics (CFD) bioreactor modeling, latent variable modeling (LVM), and reaction kinetics and thermodynamics modeling.
Formulation of Biotherapeutics
Spray-drying can be applied to a number of key biotherapeutics including peptides, proteins and virus-like particles (VLPs) for pulmonary delivery, DNA/RNA, and proteins for parenteral delivery. Bend Research offers process development and cGMP manufacturing capabilities to produce spray-dried dispersions. Our spray-drying methodology minimizes the use of valuable active pharmaceutical ingredient (API), shortens process-development timelines, and ensures scalable processes and particles.
New Devices and Prototype Engineering
Bend Research has in-house engineering expertise with extensive experience in developing and fabricating medical devices and custom bioprocess process equipment. When Bend Research scientists recognize an obstacle that can be solved with innovative design, we call on this expertise to develop creative solutions, saving our clients time and money.
Contact us to discuss your needs in biotherapeutics production.
Biotheraputics and Bioprocessing Drug Development
At Bend Research, we pursue innovative solutions that will define the future production of biotherapeutics. We work with clients to define clear problem statements and desired outcomes for each project, tailoring the work plan to achieve project goals quickly and efficiently.
An example of a past problem statement: design the “Plant of the Future,” providing the client with options for reducing the potential capital investment by half and the operating costs by two-thirds. Bend Research delivered:
- technical data packages that addressed process challenges;
- simulation packages that promoted in-depth bioprocess understanding;
- an analysis of the durability, reliability, and performance of bioprocess skids; and
- the identification and qualification of a suite of bioprocess instrument solutions that improve bioprocess understanding.