In the BioTech – I section of IFPAC 2014 (January 23rd, morning session), ProSensus president Dr. John F. MacGregor and Dr. Gene Schaefer, senior director of large molecule API development at Janssen will be presenting an overview and early results of a collaborative project between ProSensus, Janssen, the FDA, and NIST.
The project aims to demonstrate model-predictive control, monitoring, and optimization of a fed-batch monoclonal antibody (mAb) process, using multivariate (latent-variable) models.
This project is the first of its kind in terms of taking online multivariate analysis all the way to model-based closed-loop control for fed-batch cell cultures.
The objectives are to optimize productivity (titer) and simultaneously achieve more robust and improved control of product quality attributes, such as charge heterogeneity and oligosaccharide levels. These objectives will be realized by identifying (using multivariate analysis) and manipulating relevant variables in real-time while batches are in progress.
The project’s ultimate goal is to improve study designs as they relate to control strategies for fed-batch processes to ensure that such processes have the required flexibility, manipulated variables and sensors to improve the operation and control of the process. Online and at-line process analytical technologies (e.g. dielectric spectroscopy and Raman) as well as off-line characterization techniques (e.g. NMR, LC-MS and GC-MS of the media, spent media, and cells) will be evaluated for their importance in monitoring, control and optimization. The trade-offs of different combinations of techniques and process sensors will be assessed.
At its conclusion, the results of this project will provide a more effective definition of multivariate design and control spaces by incorporating control concepts and practice at the design, development, validation, and filing stages. John and Gene’s presentation will provide an overview of the objectives and scope of the project together with some of the early risk analysis, experimental, analytical and multivariate modeling results.
Contact John MacGregor to meet up with him at IFPAC 2014 in Washington DC, Jan 21-24th and to find out how this technology can be put to work in your process.
