From Candidate to Clinic: ExpediteBio’s Integrated Biologics Pipeline

Bringing an antibody from the lab to the clinic requires drug developers to consider both biological activity and key characteristics that influence its manufacturability and clinical translation. ExpediteBio was founded to help drug developers build manufacturability into antibody development from an early stage. By assessing manufacturing requirements during lead selection and optimization, ExpediteBio can identify potential production challenges before they become costly development risks. These insights guide cell line development and process optimization, ensuring that antibody candidates can be efficiently and reliably translated into scalable manufacturing processes for clinical use. 

We spoke to co-founders Richard van Rijnsoever, CEO of ExpediteBio, and Debby Vermeer-Kruijsen, co-Lead of the Oncode Accelerator Biologics Workstream and ExpediteBio’s Chief Strategic Alliance Officer, about the challenges that antibody developers face and how ExpediteBio and Oncode Accelerator help overcome them. 

Current Bottlenecks in the Development of Biologics

Richard’s career has spanned biologics development in both biotech and service environments, and he has supported programs from early discovery through to clinical development and market supply. In his view, one of the biggest challenges in developing antibody-based cancer therapies is translating a scientifically promising antibody into a molecule that is fit for development and manufacturing. “In oncology, increasingly complex antibody formats can create additional challenges around developability, stability, expression, manufacturability, and scalability,” he adds.  

Debby, who has a strong background in antibody discovery and development within contract research organizations, from hands-on scientific work to business development and general management, agrees, and adds that this challenge is often underestimated. “Delays and inefficiencies during the transition from a therapeutic lead candidate to manufacturing of a clinical-grade batch can significantly impact timelines, budgets, and investor confidence. For both scientific founders and investors, having a predictable development pathway with clear budgets and milestones is essential.” 

Fragmentation in development pathways can compound this challenge. “Discovery, process development, analytics and manufacturing are often performed by different organizations and considered sequentially,” says Richard. “This can result in important manufacturability issues being identified relatively late, leading to additional development work, delays and costs.” 

Integrating Developability, Manufacturability, and Scalability Earlier

When asked about how to accelerate the path from candidate to clinic, Richard answers, “The biggest opportunity is not necessarily to make every individual development step faster, but to make the overall development pathway more connected.” ExpediteBio was founded based on this conviction.  

Debby and Richard are convinced that the creation of one integrated pipeline should help remove unnecessary iterations, improve early decision-making, and create a more seamless transition from discovery towards clinical manufacturing. “While this may sound straightforward,” Debby comments, “successful execution requires deep expertise and careful coordination.” 

One aspect of this is providing drug developers with the expertise and technologies needed to assess developability, manufacturability, and scalability earlier, to support improved candidate-selection decisions. By considering biological activity, developability, and manufacturability early in the pipeline, the risk of redevelopment later on should be significantly reduced.  

A Single Standardized Workflow for Antibody-Based Cancer Therapies

Alongside know-how, ExpediteBio and its strategic partners deliver integrated, high-throughput, and scalable workflows for cell line development, process development, CMC (chemistry, manufacturing, and controls), and small-scale manufacturing. Supported by advanced technologies and dedicated laboratory infrastructure, the company helps drug developers generate manufacturing-ready cell lines, scalable production processes, and the supporting CMC framework required for clinical translation.  

As part of the Oncode Accelerator oncology ecosystem, these capabilities enable rapid progression from candidate selection to IND-enabling studies and early clinical manufacturing. By combining expertise, infrastructure, and automation in a single platform, ExpediteBio provides a capital- and time-efficient route toward clinical manufacturing readiness. 

Importantly, these technologies are being integrated into a standardized development workflow, rather than implemented as stand-alone equipment. The infrastructure is designed to closely mimic GMP manufacturing conditions, small-scale process development that can be effectively scaled and transferred for later clinical phases, and ultimately commercial production.  

ExpediteBio has also formed a strategic partnership with AVS Bio, a contract research organization specialized in the discovery and development of antibody therapeutics. AVS Bio supports drug developers throughout the early stages of development by combining antibody discovery, characterization, and developability assessment to identify the most promising lead candidates. 

Debby elaborates on the value of this partnership: “AVS Bio occupies a unique position within the Dutch life sciences landscape through its presence at both Pivot Park in Oss and Utrecht Science Park. Their recognition of the need for integrated development and manufacturing infrastructure, and their commitment to providing the facilities, expertise, and resources needed to realize it, have been instrumental in establishing ExpediteBio’s development and manufacturing infrastructure. This partnership enables us to deploy our integrated process development and small-scale manufacturing platform and accelerate our mission to make biologics development more efficient, manufacturable, and investment-ready from an early stage.” 

Opportunities for Demonstrator Projects 

Demonstrator Projects are collaborative, c0-funded preclinical development projects that use Oncode Accelerator’s integrated infrastructure. Through Demonstrator Projects, drug developers from around the world can work with ExpediteBio alongside other Oncode Accelerator partners.   

Depending on the development stage and objectives, Demonstrator Projects performed in collaboration with ExpediteBio can include upstream and downstream process development, generation of data to inform manufacturing strategies, and automated, high-throughput and parallel bioprocess studies. By integrating their approach within the Biologics Workstream of Oncode Accelerator, ExpediteBio also supports drug developers from an early stage of development. 

Drug developers working with ExpediteBio through the Oncode Accelerator ecosystem gain access to a wide range of expertise and technologies beyond what could be offered by any single partner alone. Debby explains: “While ExpediteBio focuses on reducing the time and complexity associated with process development and early manufacturing, Oncode Accelerator provides access to a unique innovation ecosystem, including patient cohorts, organoids, and other advanced translational platforms. Together, these capabilities help increase the probability of success, de-risk development programs, and create a faster, more predictable path from scientific discovery to clinical impact.” 

Ultimately, this work should translate into benefits for patients living with cancer. “ExpediteBio and Oncode Accelerator share the same ambition: to accelerate the development of innovative cancer therapies and bring more treatments to patients,” Debby reflects. 

Richard concludes: “If we can help promising biologics move towards the clinic faster and more efficiently by making better development decisions early on, that is ultimately what makes the work rewarding. For patients living with cancer, that means increasing the chances that promising new therapies can progress efficiently from scientific discovery towards clinical evaluation.”