Existing commercial biotherapeutic products currently manufactured with a fed-batch process may be facing low productivity/high COGS challenges which can also be correlated to supply chain bottlenecks. We can develop intensified and fully continuous process for existing commercial molecules facing a COGS challenge or requiring larger supply capacity.

• Step-wise feasibility study to assess compatibility of existing cell line and process to our continuous bioprocessing platform
• Generation of COGS reduction analysis report
• Full commercial process development
• Process characterization, validation & PPQ campaigns
• Stability studies
• Commercial DS manufacturing
  • 500/1000L scale enabling more than 50 kg batch/run
  • One J.POD^® facility offers a mass output of up to 2,500 kg/year

Just - Evotec Biologics is the world leader in the development and application of AI/ML-based molecular optimization combined with continuous bioprocessing technology. We provide an integrated suite of services for clients who are focused on the manufacturing of antibodies-based biotherapeutics, including monoclonal antibodies (mAbs), bispecific/multispecific antibodies and molecules which use antibody-like scaffolds, such as Fc fusion proteins.

Our proven continuous bioprocessing platform, which we call JP3, combines intensified perfusion cell culture using single use bioreactor (SUB) technology with fully connected downstream processing operations. Production of bulk drug substance is achieved using hybrid (‘semi-continuous’) or fully continuous (‘end-to-end’) modes of operation using either 500L or 1000L scale SUBs depending on the amount of drug substance needed.

Our Continuous Manufacturing strategy combines the flexibility of single use bioreactors (typically 200-2,000L) with the high mass outputs that can be achieved through the use of traditional large scale (typically 5,000-20,000L) stainless steel bioreactors.

An intensified perfusion cell culture process results in a high and consistent viable cell count. It also means the process is also held in a ‘steady state’ during protein expression which results in better product consistency. Cell death (apoptosis) is much lower compared to a fed batch process therefore less leakage of intracellular contents, such as proteases which can degrade the protein product, occurs.

The drug substance manufacturing process is scaled up to meet product demand simply by extending the perfusion time and increasing the number of downstream cycles. We have proven that we can increase productivity compared to traditional fed batch processes significantly.

Our fully end-to-end continuous bioprocessing strategy which can deliver up to 5-6/L/day is capable of reducing COGs for a monoclonal antibody by as much as 75% for a commercial product¹. We are committed to achieving COGS below US$ 50 per gram, as it lies at the core of our mission to ensure affordable access for all.

_{1) Garci F.A & Gefroh E., Drug Discovery Today (2023)}

The process operations are performed in a small footprint (130,000 sqft) cGMP facility. This facility contains modular cleanrooms in which are located all the required cGMP processing equipment. It also houses our process development, analytical and QC laboratories and scientists.

Using our continuous bioprocessing platform (JP3) together with our Continuous Manufacturing platform (J.POD), the product quality can be higher due to greater process consistency, the COGS are lower at commercial scale, CMC activities associated with the clinical journey can be de-risked and the overall process development effort and timeline are reduced, because the manufacturing process can remain at the same scale.

• Agile Manufacturing Solutions: J.POD introduces next-generation manufacturing solutions with its unique facility design, built around Just – Evotec Biologics’ leading continuous manufacturing technology.
• Modular Cleanrooms for Efficient Bioprocessing: J.PODs incorporate modular cleanrooms for intensified bioprocessing, reducing manufacturing space and overall plant size.
• Integrated PD Labs: J.PODs house integrated Process Development (PD) labs, streamlining the development and manufacturing process.
• Versatile and Cost-Efficient: J.PODs utilize disposable technologies and intensified processes, creating flexible and relatively low-cost biomanufacturing facilities.
• Seamless Scalability: J.PODs can accommodate production from a few kilograms to metric tons, providing seamless scalability within the same facility.
• Faster Setup Time: J.PODs offer significantly faster setup time compared to traditional facilities, enabling rapid response to market demands