J.POD
J.POD
delivers flexible capacity for manufacturing the highest quality COVID-19 mAbs at a reasonable cost
Under development Evotec SE through its Just – Evotec Biologics business unit
The U.S. Department of Defense (“DoD”) awarded
on July 22, 2020 to Evotec a contract valued up to $ 18.2m to develop and manufacture monoclonal antibodies (“mAbs”) for treatment and/or prevention of COVID-19
The Bill and Melinda Gates foundation awarded on October 19, 2020 a $1.9m grant to Just- Evotec Biologics to enable an antibody product for the prevention of COVID-19
Just – Evotec Biologics announced
the extension of its contract with the U.S. Department of Defense for manufacturing of monoclonal antibodies by $28.6m
J.POD
J.POD™ provides clinical and commercial GMP manufacturing of biologicals in a "box", starting from SARS-CoV-2 antibodies. It aims to significantly speed and scale up the current global production capacity and, thus, create access and value to global markets.
Evotec's J.POD is a bio-convergence solution, integrating the classical steps of antibody discovery, development and production processes into an iterative, holistic approach steered by machine learning and artificial intelligence.
The solution comprises fed batch, intensified fed batch, and continuous process formats, GMP cell banking for both master and working cell banks, as well as drug substance manufacturing for Tox, Phase 1 and Phase 2 clinical trials and commercial GMP manufacturing, allowing for the production from a few kilos to metric tons in the same facility.
A pilot plant is in late stages of construction in Redmond, Washington, with additional capacity intended to be developed throughout the EU.
J.POD® – industrializing the way of producing antibodies against COVID-19
our insight of the week - September 12, 2020
J.POD factory, photo courtesy company
“Traditionally, the problem with creating antibodies in a lab has been that they are expensive and tedious to develop. What we end up with are treatments that are generally limited to specific illnesses that are common in first world countries where health systems can pay for them. – We want to change that.” explains Florian von Groote-Bidlingmaier, Head of Global Health and Clinical Development at Evotec.
Von Groote-Bidlingmaier is speaking about the Just-Evotec Biologics platform and the J.POD manufacturing facility. For him, the technology is particularly resonant as he spent ten years working in South Africa where he saw first-hand the struggles and limitations placed on healthcare systems in developing countries. “You see, the J.POD is a collection of technologies in a system that will revolutionise the way antibodies are developed, enabling us to eventually treat or prevent more illnesses such as tuberculosis and malaria, around the world.” Florian, who now lives and works in Lyon, continued.
The J.POD platform technology has been developed by Seattle-based Just- Evotec Biologics which in 2019 became one of a recent flurry of acquisitions by parent company Evotec, headquartered in Hamburg, as it sought to get a foothold in the biologics industry. This acquisition cost $90m.
Justice runs like a golden thread through the work of this relatively young company (founded 2014) and not just iby name. Its founders said they chose the name because “the word suggests a sense of fairness and equality. A minority of our world is enjoying a literal medical revolution as the understanding of biology enables the discovery and development of life-changing therapeutics. At Just, our passion and mission is to help bring this medical revolution to the entire world.”
inside of a JPOD, modular flexible manufacturing, photo courtesy company
Supported by the Bill & Melinda Gates Foundation as well as a Pharma partner Just- Evotec Biologics focuses on innovative technologies for the development and manufacturing of biologics. J.POD is a biomanufacturing facility that seeks to provide high-quality molecules at the lowest possible cost in the most efficient way. It uses disposable technologies and intensified processes in small spaces.
Just- Evotec Biologics recently won a $18.2m contract from the U.S. Department of Defence (Pentagon) to develop and manufacture monoclonal antibodies (“mAbs”) for treatment and/or prevention of COVID-19. The agreement is to ensure the supply of two monoclonal antibodies directed against the SARS-CoV-2 antigens “rapidly and efficiently” – and at significantly lower cost. Thus, thanks to the company’s experience of rapid development, we might say the journey to protect and save the lives of millions is at least half-way done.
This is certainly a very “just” cause but how can it be made a reality?
Well, as Florian explains, making antibodies is a long and painstaking process. First, you need somebody who has already recovered from COVID-19 or another disease to gather the antibodies their own immune system developed to fight the virus so as to be able to map them. This pre-dates the manufacturing stage, obviously.
Florian underlines the challenges of developing large quantities of antibodies in a laboratory using very large, stainless steel tanks, countless pipes and machinery, all which would have to undergo a deep cleaning and steaming before starting work on another batch. The cleaning process would halt the lab for over a week, creating very slow turnaround times and ultimately making it very hard to react quickly to new health crises like the present coronavirus emergency.
J.POD factory, photo courtesy company
With J.POD, the core mission is to save time and cut costs at every phase of the process, focusing on process operations that significantly impact development time and product costs. Just looked at the manufacturing process (current Good Manufacturing Practice or cGMP) and had the idea of modularising the process by introducing a pod (cleanroom) system with disposable, interchangeable parts to what used to be a very laborious process. Now, instead of a cleaning process that takes a week or more and includes large volumes of water and other chemicals, they can switch out the old parts and replace them with single-use components, thereby reducing time spent to a matter of hours, saving both time and money as well as reducing the overall environmental impact of traditional processes.
And here we start to enter the promise of data science – where the computers and algorithms used at Just can map and mimic antibodies by a process of machine learning, in which they use existing databases of antibody sequences to create new therapeutic antibodies. The more antibodies that work their way through their system, the better the computer algorithms get at predicting and mimicking antibody behaviour under manufacturing process conditions, long-term storage conditions, and in-vivo therapeutic use. The algorithms are capable of working at eyewatering speeds, developing 10,000 antibody sequences a minute. The results aren’t exact human antibodies but are hyper-realistic sequences that should allow the body to respond identically with traditional human derived sequences.
Questions remain as to just how efficient, and how inexpensive, they can make the process, but the ultimate goal is to achieve a dose with a symbolic one dollar price tag, a minimal cost that perhaps even the world’s poorest healthcare systems could afford.
September 12, 2020 by ACUMEN