Robin Ernst, Research Scientist, Janssen
Developability assessment at the early stage of therapeutic antibody discovery
Our group’s responsibility is early developability assessments of larger panels of biotherapeutics for lead selection and protein engineering. In most cases we have a limited supply of starting material (and time). This presentation will demonstrate how we’ve integrated the UNcle platform in our process for overall stability analysis and B22/kD assay development.
Andrew Hagarman, Group Leader/Sr. Scientist, KBI
Formulation screening by UNit and HUNK analysis
The KBI Biopharma formulation development platform utilizes high-throughput biophysical analysis, in the early stages, to reduce the formulation design space to a feasible zone. In the later stages, the optimal formulations are exhaustively assessed for their efficacy before selecting a final formulation. UNit and HUNK analyses are used, respectively, in the early and later stages of formulation development. UNit analysis is high throughput and the data is easily interpretable. HUNK analysis is more detailed and time consuming, but can offer insightful predictions about long term stability if the data is generated and analyzed properly.
Joe Barco, Director, Product Marketing, Unchained Labs
Kick-ass combinations to answer stability questions
There is no single test that answers all questions about biologic stability. There are reasons to do some tests sooner than others, and different points in development where some measurements should be given greater significance. We will discuss some approaches of using a combination of measurements from UNcle and HUNK to rank and refine during construct and formulation screening.
John Proctor, Sr. Director, Marketing, Unchained Labs
Unleash automated buffer exchange
Buffer preparation, exchange and sample concentration for a formulation screen can take 2–4 days of a scientist’s time. While many labs have developed strategies to streamline formulation development, it’s still manual and requires significant resources which can limit the number of formulations evaluated. Unchained Labs has eliminated this bottleneck with a portfolio of products that automates buffer preparation, buffer exchange and sample concentration. We’ll show you how this portfolio can supercharge your early-stage formulation screening and transform your process in formulation development with fully automated solutions for buffer preparation, buffer exchange and data analysis.
Chris Nunn, High-Throughput Automation Scientist, GSK
Applications of the optimization sampling reactor
At GlaxoSmithKline, automation has increasingly become fundamentally integrated into process development. Process development in the pharmaceutical industry requires tools that are both flexible and have a wide range of functionality. With reaction screening being the initial intended function of the Unchained Lab’s optimization sampling reactor (OSR), its unique flexibility has enabled GSK to execute a wide range of workflows. Several workflows have been demonstrated on the OSR including reaction screening and kinetic modeling, competitive ripening, and reaction degradation monitoring covering a wide range of experimental space.
Victor Rosso, Principal Scientist, BMS
The application of lab automation towards chemical process development
The design, development and implementation of a robust, predictable, and scalable manufacturing process is the key outcome of chemical development. At Bristol-Myers Squibb, laboratory automation plays an important role in enabling large experimental arrays directed towards the discovery and optimization of reaction conditions. Rationally designed experiments are used to accelerate the discovery on new reactions and build unprecedented understanding of chemical processes via kinetic sampling of statistically designed experiments that not only probe for optimized design space but are also used to gain insight into reaction mechanisms. Through specific examples, this presentation will highlight key aspects of the application of modern, automated technologies towards reaction screening and design of experiments (DoE).