The Essential Protein Engineering Summit took place in Boston, MA at the Seaport World Trade Center this year from April 30th – May 4th. PEGS is one of the largest conferences for biotherapeutic protein drug development with over 2,500 industry professionals joining from all over the world.
This year’s conference encompassed all of the prominent industry topics including: engineering, oncology, immunotherapy, expression, analytical characterization, and bioconjugates. Not only were top scientists from around the world sharing their research posters, but the conference itself hosted more than 400 lectures, training seminars, short-courses, roundtables, breakouts, and panel discussions. The hottest topics at the conference addressed some of the most challenging scientific problems in the industry and the latest technology available to solve these problems, including:
Developability is the Emphasis of Analytical Characterization
One of the major topics at PEGS 2018 was how developability is changing the landscape of biologic drug discovery. Most drug-like properties are screened at the early stage to avoid unforeseen challenges in late-stage drug development. This approach avoids blind walking and provides risk mitigation to bring down the associated costs and shorten timelines.
Developability can help identify a quality attribute that inhibits manufacturing and formulation as well as help design a biologic molecule with acceptable physicochemical characteristics that make a drug product. Overall, developability is redefining Biotherapeutics drug discovery, and the next generation of biologics will be produced using this approach.
The majority of presentations on developability at PEGS focused on the characterization of monoclonal antibodies (mAbs). mAbs are commonly used as therapeutics due to their stability, specificity, and lower side effects. Based on this information, it is not surprising that monoclonal antibody sales are projected to be over $125 billion by the year 2020. New approaches to mAbs manufacturing are needed in order to expand the benefit of therapeutic mAbs to global health markets. Many approaches are underway, including the use of large scale manufacturing like ExpressTec.
Cutting-Edge Technologies and Emerging Therapeutics
Most of the technologies presented at PEGS 2018 were aimed at solving research and development problems. Platforms of low volume and quantity with high-throughput capability to collect large amounts of data are critical for the biologic drug development and to rapidly develop new therapeutic targets, but once identified, a large scale manufacturing technology is necessary.
One of the emerging therapeutics technologies at PEGs was the Dynapro Plate Reader III from Wyatt Technology Corp. . This system is revolutionary regarding its capability for automation and high throughput measurement of size, polydispersity, molecular mass, viscosity, colloidal and thermal stability. The speed, high throughput, and low volume requirement of this instrument are ideal for solving many of the challenges in early formulation development of biologic drugs. Both aggregation state and pathway can be examined in early and late-stage formulation development with the Dynapro Plate Reader III. Additionally, this technology had dynamic light scattering and static light scattering capabilities – a key tool in high-throughput screening of biologic formulation.
Genovis presented a novel technology for analytical characterization of O-linked glycans in biologic products at PEGS. Genovis’s approach simplifies the determination of site-occupancy and composition of O-linked glycan which has been relatively challenging compared to N-linked glycan. Overall, these innovations in glycan analysis help improve the safety and efficacy of biologic products.
Roche took a new approach on the design of a bispecific antibody format called a contorsbody at PEGS 2018. This novel monoclonal antibody design strives to achieve receptor dimerization in a structurally unique format that is particularly impressive. Interestingly, the cantorsbody format is purifiable with protein A. The FcRn interaction showed a similar profile to standard mAbs with a reduced Fc-effector function. These emerging therapeutics can dramatically change the way antibodies are designed, similar to the advent of antibody drug conjugates (ADC) over a decade ago.
Future Biologic Drug Development
At PEGS 2018, it was clear that our biotherapeutic protein drug industry is moving towards high-resolution techniques, such as the utilization of mass spectrometry in early drug discovery as well as late-stage structural characterization. Rapid innovation was evident by Agilent’s debut of its new mass spectrometry equipment. High-throughput technology that allows simultaneous characterization of critical quality attributes and which rapidly generates large amounts of data will be key to solving challenges and improving quality in the development of therapeutic products.
From this conference, it was clear that monoclonal antibodies (mAbs) will remain the most prevalent biologic drug platform for the foreseeable future in the treatment of cancer, rheumatoid arthritis, and inflammatory diseases. However, Biologic products that are currently expensive may see improved manufacturing efficiencies, shorter drug product timelines and lower development costs thanks to the development of a standardized and high throughput analytical techniques and development of large scale manufacuturing technologies. This would help make these medicines more affordable to patients around the world in the near future. Overall, it was clear from the past week in Boston that the future of biologic drug development looks bright thanks to cutting-edge technologies and innovation.
Solomon Okbazghi, Ph.D is a formulation scientist at Ventria Bioscience Inc.
Ventria Bioscience Inc. is a biopharmaceutical company with a product pipeline targeting unmet medical needs. Ventria Bioscience’s proprietary ExpressTec biomanufacturing technology enables the development of new, safe and effective biologic products to treat gastrointestinal, autoimmune and infectious disease.
For more information, visit Ventria.com.