Bispecific boon

BASEL, Switzerland & SEATTLE—Aptevo Therapeutics, a clinical-stage biotechnology company, has adopted the Genedata Biologics platform from Genedata, a provider of advanced software solutions for biopharma R&D, as its preferred bioinformatics solution provider. Aptevo reportedly will use the platform to increase throughput and efficiency to expand its own ADAPTIR bispecific candidate discovery process focused on potential drugs for immuno-oncology, autoimmune disease and inflammation.

As Dr. Peter Pavlik, director of molecular biology and protein engineering research at Aptevo, said, “We determined that Genedata Biologics was the best solution to fully address all our unique workflow requirements, as it enables scale-up of the screening, engineering, production and testing of complex multispecific antibody candidates. The challenge Aptevo faces is similar to the challenges of other biotechs: with the advent of multispecific antibodies, today’s biotechs must evaluate increasing numbers of next-generation antibody molecule formats. Significant bottlenecks are complex, high-throughput molecular biology and cloning processes required for systematically generating DNA constructs to express the desired molecules.”

Genedata Biologics is an established workflow system that Aptevo now uses for the systematic design and cloning of large numbers of novel molecules. The platform also automates downstream expression, purificatio, and characterization processes, which substantially increases the overall throughput across the whole end-to-end process.

The platform enables scientists to access all project information in real time. The ability to immediately see the status of any project at any time allows for more informed and rapid decision-making at all levels, from corporate leaders to scientists, engineers and technical staff. This frees up valuable time for the R&D teams to focus on critical scientific tasks, such as analyzing a candidate’s developability and manufacturability profile, to make earlier, informed decisions on the best drug candidates to move forward. Ultimately, Genedata Biologics helps Aptevo scientists to spend their time on science rather than on manual IT housekeeping tasks, reporting or data management.

As a result of adopting Genedata Biologics, Aptevo has increased its molecule and sample throughput, and at the same time is able to capture, process and interpret the huge amount of resulting R&D data along their ADAPTIR end-to-end discovery process.

“We are excited to work with Aptevo, an innovative leader in the development of novel immunotherapies. This partnership illustrates how Genedata works with future industry leaders who need a platform for scale-up and automation of their R&D operations as they grow as an organization,” commented Dr. Othmar Pfannes, CEO of Genedata. “We are committed to helping our partners—both large and small—be innovative and, at the same time, efficient.”

Since its first release in 2011, Genedata Biologics has been rapidly adopted by leading biopharmaceutical companies, as well as emerging specialty biotech companies. Genedata’s collaborations range from single group installations to large, global, multi-site partnerships and include technology transfer, customizations, project management, training and rollout and deployment support.

According to Pfannes, the platform is the only out-of-the-box workflow platform for biopharma R&D, and is specifically designed from the start for large molecules. Additionally, it enables complex workflows (including the ADAPTIR technology), increases process efficiency and quality, enhances transparency and communication (cross-site/cross-function), improves decision-making within and across projects, enforces data integrity and compliance through consistent data recording and enables full automation and scale-up of operations. Its flexibility was important in Aptevo’s decision to implement Genedata Biologics—Aptevo’s R&D operations required an integrated and scalable informatics infrastructure that could be tailored to support specific biologics discovery processes, and in particular Aptevo’s ADAPTIR technology, with only minimal configuration.

Aptevo is collaborating with long-term Genedata partner MorphoSys, a biotechnology company involved in the development and research of antibodies. Aptevo was looking for a platform to increase throughput and to scale up its bispecific antibody discovery operations. The new platform needed to increase general efficiency of R&D teams by facilitating communication and sample handovers between various R&D teams and functions, including screening, molecular biology, engineering, expression, purification and analytics. After a thorough evaluation of the market, Aptevo decided to implement Genedata Biologics as its corporate “data backbone” to capture and process all data generated by its R&D programs, according to Pavlik.

Key decision criteria to implement Genedata Biologics also included out-of-the-box capability (deployed across the organization with only minimal customization), end-to-end (full process) coverage and cloud deployment (ease of operation). Genedata supported the Aptevo teams with technical support during the deployment and go-live phase.

“Using Genedata Biologics as their central workflow platform, Genedata customers report more than 50-percent efficiency gains in their R&D operations,” Pfannes said. “It is expected that Aptevo will also realize comparable efficiency gains.”