This paid-for advertorial by Berkeley Lights appeared in DDW Volume 22, Issue 2 – Spring 2021
The Covid-19 pandemic has illuminated how a coordinated response to infectious diseases can result in the development and commercialisation of novel vaccines and therapies at record pace. Several therapeutic antibodies and vaccine candidates entered clinical trials in just months, a process that can traditionally take years and is subject to high failure rates. Looking into the future, what can we learn to accelerate discovery and development of new therapeutics against other important diseases?
One of the key features of the pandemic response was the forging of global partnerships between researchers and drug developers to utilise state-of-the-art technology. Berkeley Lights, a leading digital cell biology company, established multiple partnerships worldwide that provided access to their fully integrated platform to cut development times in half and accelerate the discovery and development of both therapeutic antibodies and vaccine candidates for Covid-19.
Discovering and transferring lead antibody molecules to manufacturing in less than three weeks
The first step towards the clinic is identification of candidate molecules that have the therapeutic function of interest. In the Spring of 2020, Berkeley Lights worked with scientists at Vanderbilt University Medical Center (VUMC) to utilise the Opto™ Plasma B Discovery workflow on Berkeley Lights’ Beacon® optofluidic system to quickly identify lead antibody molecules from some of the earliest identified patients with SARS-CoV-2 infection in North America. In just one day, the Opto Plasma B Discovery workflow enabled direct functional profiling of B cells to select antibodies that neutralised the SARS-CoV-2 virus by binding to Spike protein and blocking its interaction with the human ACE-2 receptor. This allowed VUMC to deliver sequences of confirmed SARS CoV-2 neutralising antibodies to downstream manufacturing partners in just 18 days1. Through state-of-the-art technology offered with the Beacon system, VUMC was able to accelerate their discovery timeline when time was of the essence. Less than six months after discovery, two of these antibodies formed the basis of an AstraZeneca antibody cocktail for the treatment of Covid -19 that is currently in Phase III clinical trials, and as of February 2021, this antibody cocktail has proved effective against variants of Covid -19 in early testing2.
Generating manufacturing cell lines to advance lead molecules to the clinic in less than six months
While VUMC was discovering lead molecules using the Opto Plasma B Discovery workflow, Berkeley Lights was simultaneously working with the University of Queensland (UQ) on the other side of the world to accelerate the generation of manufacturing cell lines for their Covid-19 vaccine candidate.
Berkeley Lights worked with UQ to create a bespoke cell line development assay, which enabled the UQ team to isolate clones with 10-fold higher titer than they had previously recovered using traditional technologies – all in just two weeks. The Opto™ CLD workflow enabled rapid translation of these molecules into manufacturing cell lines using a variety of quantitative assays, rapid expansion, and FDA-accepted monoclonality assurance. And importantly, the Berkeley Lights team was able to remotely develop and deploy this custom assay, which saved valuable time in the race to advance potential Covid-19 therapies to the clinic. As Samantha Black, Editor in Chief of The Science Advisory Board, put it, “Perhaps most impressive of all, these significant changes…were all made online. Due to Covid-19 travel restrictions, the scientists at Berkeley Lights and the University of Queensland worked together virtually to develop an entirely new assay and push the vaccine candidate toward a Phase I clinical trial.”3
From drug target to IND on a single platform
When compared to traditional methods, the powerful combination of antibody discovery and cell line development on the Beacon system enabled drastic reduction of drug discovery and development timelines. The Beacon system allowed for direct functional profiling of B cells from Covid-19 patient samples to rapidly select lead molecules and a customised assay was developed to help generate and advance a manufacturing cell line which collectively enabled both therapeutic antibodies and a vaccine to enter clinical trials in less than six months. The Beacon system is the only integrated platform able to successfully support both the antibody discovery and the cell line selection phase of bringing biologics to market. This provides an additional efficiency as drug developers are no longer forced to invest substantial time and effort into acquiring disparate technologies that must be integrated into a single development process. Instead, the Berkeley Lights platform offers a fully integrated, single state-of-the-art technology that provides access to one of the fastest paths from drug target to commercialisation on a single system.
To learn more about how leading pharmaceutical companies, CROs and CDMOs, and academic centres have implemented the Berkeley Lights platform visit; berkeleylights.com/Target-to-IND.
Volume 22, Issue 2 – Spring 2021
References
1 Zost, SJ et al. Rapid Isolation and Profiling of a Diverse Panel of Human Monoclonal Antibodies Targeting the SARS-CoV-2 Spike Protein. Nature Medicine. (2020 (https://www.nature.com/articles/s41591-020-0998-x)
2 https://www.nature.com/articles/s41591-021-01294-w
3 https://www.scienceboard.net/index.aspx?sec=sup&sub=imm&pag=dis<emlD
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