The Chromatography Forum

of Delaware Valley

Robert Luo, PhD, Manager, Downstream Process Development, Medicinal Science and Technology, Pharma R&D, GSK

Title: Scientific and practical considerations for small scale model qualification of chromatography in bioprocessing

Abstract: The qualification of small scale models for biopharmaceutical manufacturing processes is an important task that supports process validation and is required by regulatory authorities. However, carrying out small scale model qualification studies can be challenging due to the lack of clear guidance on the best practices for design, execution, and data analysis. For example, common questions asked by scientists and engineers tasked with conducting qualification studies include
•             “How many large-scale runs do I need to qualify the model?”
•             “How many small-scale runs do I need to carry out in the lab?”
•             “If the manufacturing scale or site changes, do we need to qualify the model again?”
•             “What statistical methods should I use to analyze the data?”
In this presentation, we will evaluate these questions based on experiences with qualification of small scale models. In addition, we will discuss proposed answers to the questions based on scientific, statistical, and practical considerations.

Joshua Fuller, Manager, Biopharm Analytical Sciences, Medicinal Science and Technology

Pharma R&D, GSK

Title: Protein Therapeutics Analytics – Matching State-of-the-Art Separation Techniques with Current Data Analysis Expectations

Abstract: With the prevalence of bio therapeutics in the marketplace and in pharmaceutical companies’ pipelines, the demand for thorough product understanding and high quality control is increased. Complex in nature, these large molecules require a battery of analytical methodologies, including a variety of separations-based techniques, to ensure product characterization, quality, and safety.  In this talk, the needs for various chromatographic modalities and advances in their application will be discussed. Consideration will also be given to the complex data generated.