Berkeley Lights’ unique function-first approach provides advancements in timeline, quality, and revenues
In recent years, antibody therapeutics have become high-value targets accounting for 9 of 20 top-selling therapeutics and nearly 20% of all FDA approvals. Development of this class of drugs, however, is plagued by particularly low success rates due to limitations in effective screening early in the discovery and development process. The resulting late-stage failures not only waste precious time, but also drive up costs while limiting the number of antibody therapeutics that make it to market.
Berkeley Lights is uniquely positioned to address these challenges with a platform that accelerates delivery of investigational product to clinical trials by assessing quality of both antibodies and manufacturing cell lines at the earliest available phase of discovery and development. Already adopted by many top 25 pharmaceutical companies, as well as leading CROs and CDMOs, the Berkeley Lights Platform is actively being used to deliver high-quality therapeutics to clinical trials in record time.
John Proctor, Senior Vice President of Antibody Therapeutics at Berkeley Lights, shares insights into how the Berkeley Lights Platform is transforming antibody therapeutics and how a novel, subscription-based model now broadens access.
How does the Berkeley Lights Platform change the economics of antibody therapeutic development?
John Proctor: Berkeley Lights has created a platform that not only shortens timelines for antibody discovery and cell line development but also brings functional and quality assessment earlier into discovery and development.
Our novel approach addresses two prevalent challenges in today’s workflows: lengthy timelines to bring an antibody to clinical trials and a high failure rate. This adds up to price tags well above 1 billion USD to commercialize a single molecule and 10+ years spent to get from target to approval. And COVID aside, these numbers are not improving. Bringing a molecule to market today is more difficult because of the focus on GPCRs and other difficult targets and more complex molecular formats, such as bispecifics and antibody fragments.
Using the Berkeley Lights Platform, our customers can bring more and better molecules to clinical trials faster, expanding pipelines and enabling millions in revenue.
Our customers can bring more and better molecules to clinical trials faster, expanding pipelines and enabling millions in revenue.
Tell us about how your platform has already changed your customers’ discovery and development processes.
John Proctor: Across the board, our customers are reporting reduced timelines and greater success against difficult targets. GSK has shaved three months off their CLD critical path timelines. The Crowe lab at Vanderbilt University was able to go from human donor to manufacturing-ready SARS-CoV-2 neutralizing antibodies in 18 days. Customers are finding antibodies against GPCRs and other challenging molecules where their hybridoma-based workflows failed. They are finding clones with 3-fold higher titer. And they are doing this in record time.
This year, with the release of our fourth-generation antibody discovery workflow and the addition of Opto™ Assure quality assays to our CLD workflow, customers will undoubtedly realize additional improvements because we enable them to assess function and quality much earlier in discovery and development. This function-first approach promises to streamline development and continue to drive down timelines.
We enable [our customers] to assess function and quality much earlier in discovery and development.
Why is this function-first approach so critical to increasing success rates and building more sustainable antibody therapeutic programs?
John Proctor: For both discovery and development of antibody therapeutics, assessing function and quality as early as possible translates into not only speed and efficiency but also higher quality product, more robust pipelines, and maximized economics.
A key challenge of current workflows is that they are unable to eliminate non-functional antibodies and cell lines that secrete poor quality product during primary screening. Significant resources are spent on continued development of molecules and cell lines that are destined for costly late-stage failure.
In antibody discovery, primary screens merely identify hits. These then must be advanced to laborious down-selection in secondary screens. This is a very inefficient and also disappointing step – you are advancing 10, 100, or 1,000 hits and often these screens yield just a handful or even no functional lead molecules. By folding functional characterization into the primary screen, our newest antibody discovery workflow lets our customers go directly from target to 1000s of functionally characterized lead molecules in less than 1 week. Customers can now link functional profiles to antibody sequences and re-express lead molecules with our rapid re-expression kit in just 2 days without gene synthesis and cloning. In just a little over 1 week, they can complete the discovery process through functional confirmation and selection of the best lead candidates.
Our cell line development customers are faced with similarly costly late-stage quality assessment. The more complex antibody therapeutic formats we see today are prone to quality issues including aggregation, which impact manufacturability, shelf life, and safety. Clone selection today, however, is generally made solely on titer and it is not until scale-up that product quality issues come to light. This means development teams spend significant resources carrying multiple cell lines through to the costly scale-up process in order to ensure success. Our Opto Assure assays change this by bringing product quality assessment into early clone selection to help minimize risk during scale-up and to enable selection of clonal cell lines with favorable manufacturability profiles. This leads to decreased scale-up costs and ultimately better downstream products.
In both antibody discovery and cell line development this function-first approach translates to accelerated timelines and millions in enabled revenue.
How does your new subscription model expand access to the Berkeley Lights Platform?
John Proctor: Our customers have been requesting tailored access to our technology that better matches their capacity needs. The all-inclusive TechAccess* subscription program now provides access to our antibody discovery and cell line development workflows with no up-front capital expense or long-term commitment and provides the desired capacity flexibility. Those with lower capacity requirements are particularly eager to take advantage of a model that now matches their throughput. Since the release, we have seen a positive customer response to this program and we encourage anyone who is interested in adopting the Berkeley Lights Platform to reach out to us to schedule a personalized consultation to understand which access model, purchase or subscription, best suits their needs.
Reach out to the expert to learn more:
John Proctor, PhD
SVP Antibody Therapeutics at Berkeley Lights
*TechAccess subscriptions are currently available in select regions.
For research use only. Not for use in diagnostic procedures.