Integrated Continuous Biomanufacturing Conference
Join us in-person in Sitges, Spain for the Integrated Continuous Biomanufacturing Conference where Just-Evotec Biologics will be presenting.
- Lisa Connell-Crowley, VP Process & Product Design
- Eva Gefroh, VP Technical Operations
- Brian Follstad, Scientific Director Process Science
- Caroline Mueller, Scientist Purification
Presentation | 11 October at 9:20am
Key Enablers of Continuous Manufacturing Success Through a Flexible J.POD® Platform
At Just – Evotec Biologics, we strive to deliver low-cost, high quality biopharmaceutical manufacturing to dramatically increase global access to biologics. Our assessment of cost reduction drivers has guided our technology platform towards two key areas: 1) the development of a continuous process platform using an intensified, high productivity, longer duration cell culture process, and 2) the design of our J.POD® manufacturing platform, a flexible and modular facility that leverages single-use technology with a lower cost of capital investment and greater speed of construction.
The road to fully integrated continuous manufacturing implementation is long, starting from initial concept ideas, moving to proof of concept through process development and engineering runs, and ultimately working toward the goal of commercial GMP implementation. Being at the leading edge of technology development means that the road to implementation can be challenging as technology elements are not always commercially available and, in some cases, custom-design solutions must be developed. We will share our experiences building our first J.POD facility and highlight the key technology components that have enabled success. One key enabler is the application of single use technologies and the development of fully and functionally closed system procedures to mitigate contamination for long duration operations. Another set of key enablers are the process systems and automation that are specifically designed for continuous processing. We will highlight a few examples to show how complexity of design results in simplified operational performance and discuss strategies used to maintain process control. Finally, advanced process monitoring and analytical tools used to assess continuous process performance will be shared. These examples represent our lessons learned along this journey of continuous processing implementation.
Presented by Eva Gefroh, VP Technical Operations
Session 4 | 12 October at 7:00am
ICB Strategies to Address Industry Challenges and Opportunities
Session chaired by Lisa Connell-Crowley (Just-Evotec Biologics) and Anurag S. Rathore (Indian Institute of Technology Delhi)
Assessing the Sustainability of Fed Batch & Continuous Process Formats for mAb Manufacturing via Bioprocess Modeling
Presented by Caroline Mueller, Scientist Purification
Conversion of an intensified fed-batch to an integrated continuous bioprocess
Despite advances in upstream and downstream Integrated Continuous Bioprocessing (ICB) technologies, reducing manufacturing costs and process development costs continue to be a concern.
- Conversion of a fed-batch (FB) or intensified fed-batch (IFB) process into a hybrid or end-to-end ICB process may be particularly challenging but manageable using key platform elements:
- High specific productivity cell lines
- Low-cost, concentrated perfusion media formulations
- An optimized and scalable cell-retention device
- The impact to product quality remains as a potential issue stemming from higher culture cell densities, longer culture durations, and differences in product residence times.
This work involved the rapid conversion of an IFB mAb process to a hybrid ICB process using the Just-Evotec Biologics platform, resulting in several key project accomplishments:
- Mitigation of upstream IFB challenges: Filter fouling due to higher culture cell densities and durations was addressed by controlling cell density and implementing continuous harvest (CH).
- Significant productivity increase: 5-fold increase in product mass per working volume compared to original FB process at the 500L manufacturing scale.
- Short development time: < 6 months from project start to cGMP batch completion.
- Minimal risk from changes in product quality: most attributes (HMW and rCE) and process impurities (HCP, DNA, and Pro-A) comparable (minor differences in glycan distribution).
These results demonstrate that the rapid conversion of FB and IFB mAb processes to ICB can be met when implementing a robust ICB platform, thus supporting the biotherapeutics industry’s need to quickly adapt to changing clinical and business circumstances.
Presented by Brian Follstad, Scientific Director Process Science
Eva GefrohVP Technical Operations
Eva brings 24 years of biologics development and manufacturing experience to the Just – Evotec Biologics team. Eva currently leads the Technical Operations group for the Seattle and Redmond GMP manufacturing facilities, focusing on the design and implementation of a continuous platform technology from bench to manufacturing scale. Eva built the Technology Operations team to bridge Process Design and Manufacturing Operations; and is comprised of experts in equipment design, process automation, manufacturing execution systems, validation, modeling, process transfer, and includes a J.POD expansion team to support Just – Evotec Biologics’ growing network of J.POD manufacturing facilities worldwide.
Prior to joining Just Biotherapeutics in 2015, Eva held scientific/engineering roles in Cell Culture Process Development at Merck & Co., and Purification Process Development at Immunex and Amgen. Eva has downstream expertise in filtration, viral clearance, chromatography, and process modeling. Additionally, she has served as CMC Process Team Lead for a late-stage program and continuous process technology implementation. Eva has authored multiple publications, contributed to numerous regulatory filings, and is a named inventor on multiple patents. Eva earned a B.S. in Chemical Engineering from the University of Minnesota.
Lisa Connell-CrowleyVP Process & Product Design
Lisa brings over 20 years of experience in CMC process development to Just – Evotec Biologics, working on a broad range of large molecule biotherapeutics at early and late stages of development. She currently leads the Process and Product Design functions, an innovative group of scientists and engineers that design cell lines, media, bioreactor and purification processes, analytics, drug product and automation for integrated, continuous manufacturing operations, across Just’s Seattle, Redmond, and Toulouse sites.
Prior to Just, Lisa spent 12 years at Amgen as a downstream group leader, with expertise in downstream process development and scale-up, batch and multi-column chromatography, high throughput resin screening, and viral clearance strategies. Additionally, she has been a CMC process team leader for several early and late stage monoclonal antibody, Fc fusion and biosimilar products. She has authored multiple regulatory filings for different jurisdictions and participated in face-to-face interactions with the FDA. Lisa received her Ph.D. in Biochemistry from Baylor College of Medicine in Houston TX, with a focus on the activity and regulation of cyclin-dependent kinases. She also completed a post-doc at Fred Hutchinson Cancer Research Center in Seattle, WA researching the role of cyclin dependent kinases in fruit fly nervous system development.