Mechanistic Modelling in Early Stage Chromatography Process Development for Improving Process Efficiency and Productivity
19th April 2021 | 10:00am PST | Yuyi Shen, Associate Director, Process Development and Manufacturing at Bolt Therapeutics |BOOK FREE SEAT FOR THIS WEBINAR
This webinar provides an overview of current process innovation challenges and needs. The presenter identified that computational mechanistic modelling can be used to simulate chromatographic process performance and process optimization. Various case studies, applications and lesson learned from Modeling will be shared by the presenter. The webinar concludes a comparative analysis between empirical and mechanistic modeling and provide the insights of balance needs for both approaches.
Presented by Yuyi Shen, Associate Director and Head of Process Development & Manufacturing at Bolt Biotherapeutics.
Yuyi Shen is the associate director and head of process development & manufacturing at Bolt Biotherapeutics. She served scientific leadership roles in process development and manufacturing science department at various biotech companies including XOMA, Bayer and BioMarin and Grifols. She holds a PhD degree in Chemical Engineering from University of California, Davis. Yuyi provide scientific and project management leadership with specialty in recombinant protein and mAb conjugates process improvement, scale up, technical transfer to bioprocess manufacturing internally and externally and had extensive CDMO management experiences. She had solid trouble shooting and problem-solving skills and encouraging contract manufacturer to deliver with high efficiency and better quality under accelerated timeline.
Followed by Nick Whitelock, Business Development Manager at GoSilico GmbH
Nick Whitelock is the Business Development Manager for GoSilico. He uses his extensive background in DSP development and operations, from microscale to pilot-scale processing of mAbs, fabs and viral vectors to understand the issues facing the industry. His wide expertise in simulating biopharmaceuticals, including developing structural, economic and mechanistic models, helps him bring sophisticated mathematical solutions to bioprocesses. He has studied for a BSc in Chemistry with Pharmacology, a scholarship-funded MRes in Structural Biology and an EngD in Biopharmaceutical Process Development. Nick lives to accelerate the adoption of mechanistic model-based process development to enable more efficient, robust and scalable processes across the industry, and therefore more accessible medicines.
Sponsored by GoSilico GmbH
GoSilico offers a disruptive simulation technology delivering the most rapid and cost-effective development and manufacturing of biopharmaceutical drugs, while enabling scalable and flexible on-demand production of novel biopharmaceuticals.
Its DSPX software provides biopharmaceutical companies with a versatile and powerful simulation tool to develop and optimize processes in silico, i.e. on the computer. Besides groundbreaking savings in time and costs, the technology enables the risk reduction of a delay or failure in process development, and the fulfilment of growing regulatory expectations on process understanding.
DSPX enables simulation, and therefore optimisation and improved process understanding, through mechanistically modeling downstream processes. This is achieved by describing the underlying phenomena with established laws of kinetics, thermodynamics and hydrodynamics, and then coupling these effects together to simulate the complex emergent behaviour that these simple phenomena produce. This approach provides a digital twin based upon these fundamental laws, supported by a very lean experimental workflow designed with high information density, in stark contrast to black-box statistical approaches.
Five years after the company’s foundation, already more than half of the global top 10 biopharmaceutical players trust the market leader in digital process development and base their processes development on DSPX. Vendors and CDMOs are further reshaping their offering based on GoSilico’s unique technology. Besides DSPX, GoSilico offers high class implementation packages and a comprehensive service portfolio.