Streamlining Biologics from IND to Commercial Scale with Continuous Manufacturing

At Just - Evotec Biologics, our goal is to help customers bring their antibodies and next-generation biologics to market faster, reliably, and with a more efficient process that will reduce production costs. A central component in this mission is our comprehensive J.DESIGN service, which integrates AI/ML-driven antibody selection and optimization, high-expression cell lines, and continuous manufacturing infrastructure to support every phase of biologics development – including design, optimization, and commercial production.

For example, at the earliest stages we can select and optimize antibody variants with favorable manufacturability profiles, which helps to smooth the path to process development. Our manufacturing platform – built on an intensified, continuous process and using our proprietary J.CHO™ High Expression System – is highly robust and allows us to bypass many aspects of traditional process development by confirming product fit rather than building a new process from scratch. Because this platform is highly productive, we can consistently generate more than enough material for first-in-human studies. However, our customers are also welcome to integrate their own cell line.

Supporting greater efficiencies
 

Integrating cell line development and process development has a huge impact on minimizing inefficiencies. By integrating development activities, we can initiate process development, formulation and analytical work even before cell line development is complete, shaving weeks – even months – off development timelines.

Another powerful advantage of our manufacturing platform is that scale-up is unnecessary. Unlike fed-batch processes that often require facility and equipment changes in late-phase or commercial production, our approach relies on running the same process for longer, or at slightly higher volumes. We typically move from a 500 L to a 1,000 L perfusion bioreactor and extend the production duration – without changing facilities, equipment, or operating teams. This continuity also streamlines the path to filing because data collected during early clinical manufacturing can support commercial submissions.

Perfusion technology supports higher product quality by minimizing residence time in the bioreactor, reducing the risk of enzymatic or chemical degradation. The continuous process maintains cell health and product stability throughout, making it particularly advantageous for complex or fragile molecules, such as bispecific antibodies. Downstream, material flows continuously through purification steps with minimal hold times, further preserving product integrity.

Continuous product collection through perfusion enables highly efficient downstream processing. Our multicolumn protein A capture systems run a high number of cycles per campaign, significantly reducing resin consumption compared to the 5 or 10 cycles typical in fedbatch. This level of intensity applies across the downstream process, supporting both cost-efficiency and facility compactness. Integrated and de-risked approach Our regulatory affairs team will engage from day one to align development work with each client’s investigational new drug (IND). We’ve filed our own INDs, including Modules 1 through 5, so we understand the full scope of regulatory expectations. Clients can lean on us for as much – or as little – support as they need. Some prefer a hands-on approach; others want us to act as their de facto regulatory department. The choice is yours.

Our J.POD^® facilities were purpose-built for continuous biomanufacturing, and can support first-in-human and early phase clinical, late phase clinical, and commercial production. By controlling cell line development, process development, and manufacturing under one roof, we can detect and mitigate issues earlier. This tight integration minimizes risk and supports faster, more reliable development, with fewer handoffs, faster timelines, and a more seamless experience for partners. Competitors with less integrated approaches may only catch problems later, which can delay timelines and increase costs.

We have J.POD^® facilities in both the US and Europe, allowing us to manufacture close to key markets and patient populations. However, we can also work with clients to integrate our platform into their own infrastructure. We provide design, intellectual property, and technical expertise to help clients achieve the same operational efficiency we see in our sites.

The future of biologics manufacturing isn’t just faster; it’s smarter, more connected, and built for agility at every stage.

www.just-evotecbiologics.com