Services
Process Development & Optimization
Process Development Services
Wheeler Bio’s world-class process development team is well-versed in CMC process development, optimization, and process transfer refinement strategies. With decades of experience and expertise and a proven reputation of developing robust manufacturing processes within efficient timeframes, we offer comprehensive solutions to meet your CMC development and drug substance delivery needs.
Our teams de-risk early phase development by evaluating up to four therapeutic antibody candidates early in development to help our clients choose the best molecular format for their products. Once a final antibody candidate is selected, Wheeler uses a high throughput format for process development utilizing our process platforms for rapid development of robust processes that provide reliable scalability for manufacturability of Toxicology and Clinical material supply.
Contact us today to learn more about how we can accelerate your bioprocess development journey.
Comprehensive Suite of Process Development Capabilities
To ensure that our clients enter early-stage manufacturing with the highest likelihood of success, Wheeler implements a thorough process development strategy that includes the screening of upstream and downstream platforms for up to four (4) product candidates, with cell lines either provided by our clients or generated through our Portable CMC™ cell line development (CLD) offering.
Using up to four top product candidates, process development is executed using high-throughput equipment such as the AMBR15 and AMBR250 bioreactors and TECAN purification techniques, followed by more traditional 3L and 10L bioreactors and AKTA Avant purification systems to emulate the manufacturing unit operations. Once the upstream and downstream process conditions are defined, the chosen antibody candidate and top cell clone are taken through a 3L, 10L or 40L process confirmation run resulting in an analytical certificate of testing (CoT), a process verification report, and the generation of up to two hundred (200) cryovials of interim reference standard (iRS) material.
Wheeler’s process development strategy is tailor-made for clients seeking to optimize and de-risk their antibody therapeutic program in advance of their IND filing, improving their likelihood of success as they approach clinical trials.
Our Oklahoma City Integrated Process Development Lab houses a comprehensive suite of upstream and downstream process development capabilities, including:
- Basal and Feed Media Screening and Optimization to enhance process performance and productivity
- Fed-Batch or Perfusion Process Intensification strategies to optimize cell growth and productivity
- Chromatographic and Filtration Unit Operation Development for efficient purification and separation of target molecules
- Process Characterization and Compatibility Studies based on a quality by design (QbD) approach to identify key and critical parameters and their associated control limits that ensure robust and consistent performance, with subsequent compatibility studies to assess the compatibility of your process with various formulation and storage conditions
- Development of Liquid or Lyophilized Formulations that can help to optimize stability and ensure long-term product integrity
Process Development with Portable CMC®
Our Portable CMC™ offering delivers drug substance processes with reduced risk, standardized materials, robust yields, and demonstrated scalability. Wheeler’s state-of-the-art facilities achieve this objective by leveraging our Portable CMC™ process platform that has been proven over multiple mAb programs. In addition, our digital tech-stack utilizing Synthase-based automation, and DataHow bioprocess modeling provides a continuous flow of data that enables refinement of the final process prior to Tox material generation and GMP clinical drug substance supply.
Get Started with Wheeler Bio
Whether starting a process from scratch using your cell line of choice, optimizing an existing process, or utilizing our Portable CMC® platform for mAbs, our expert scientists can deliver cost-effective and scalable methods for drug substance preparation.
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