Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

Biogen is adopting modelling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial, particularly when implementing data-driven models that rely on process experience. A well-planned modelling continuum should allow the pharmaceutical industry to realize the benefits from modelling activities early on while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).

Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

Dr Romero-Torres is a Senior Manager of Advanced Data Analytics at Biogen where she leads a team of mathematicians, statisticians and Advanced Process Control engineers. She has over 15 years of experience in the fielding of Process Analytical Technologies (PAT) and advanced manufacturing of biopharmaceuticals with a focus on the use of advanced sensors, advanced process control, data analytics, machine learning and operational excellence tools. She obtained a doctorate in pharmaceutical PAT from Purdue University in 2006 and has worked for companies such as Schering Plough, Wyeth, and Pfizer. In 2014, Dr Romero-Torres founded Bio-Hyperplane LLC, a data analytics and consultation company. At Bio-Hyperplane LLC, Romero-Torres worked with a broad portfolio of industries including biopharma, automation software (semiconductors), data analytics software and instruments. Her personal mission is advancing pharmaceutical manufacturing processes to enhance plant operations and, more importantly, improving patients’ access to critical therapies.
 
Followed by David Lovett, Managing Director at Perceptive Engineering

David is on the board of a variety of process industry steering groups, including the Innovation Strategy Team, and Process Control and Analytical Measurements Apprenticeship scheme.
Perceptive expanded into Asia (Singapore in 2012), where David has developed the company with partners such as Pfizer, GSK, Unilever and Abbott Nutritionals to be recognised as one of the leading Advanced Process Control companies in the region.
Having recently published in the Parliamentary Review the benefits of government investment in manufacturing within the Process Industries, and the need for collaborative engagement, as demonstrated through the AMSCI projects, he continues to push for greater government support on Industry 4.0 initiatives.
He has published numerous technical articles including “Improving Quality and Profitability with Evaporators and Dryers using Advanced Control Technology”, “Adaptive on-line moisture control of flash drying processes”, “An econometric approach to justifying advanced process control projects”, An Integrated Approach to Advanced Process Control with Process Monitoring” and Statistical Process Monitoring of Industrial Batch Processes” and “Process Analytical Technologies and real-time control; A review of some spectroscopic issues and challenges”; “APC for Hot Melt Extrusion”; “Advanced control of a continuous oscillatory flow crystalliser”.
And John Mack, Engineering Director at Perceptive Engineering

John is a founding member of Perceptive Engineering. He is a Chartered Engineer with a BEng/NZCE from Auckland University and 17 years’ experience delivering industrial Advanced Process Control and Multi-Variate Monitoring solutions. John is the Engineering Director for the UK office. His role is to support the team delivering APC and optimisation systems in the paper, nutritional powders, water treatment and pharmaceutical industries.
Sponsored by Perceptive Engineering

Perceptive Engineering are experts in data analytics, process modelling, continuous process verification and data-driven model-based predictive control.  Their award-winning software operates within a Windows™ environment, interfacing to client processes using industry-standard protocols.  It has been designed to be both powerful and intuitive.
The company is ISO-certified, for the development of its software, as well as for the design and delivery of advanced automation schemes at client sites.
The company’s software suite – PerceptiveAPC – provides a feature-rich off-line development environment alongside a comprehensive and robust platform for real-time deployment.  Models developed off-line can be easily transferred to the real-time system for rapid implementation with minimised risk.
In the pharmaceutical sector, Perceptive’s PharmaMV software suite enables rapid scale-up from lab to pilot plant to full-scale optimised manufacture, by providing tools for the design of experiment, data validation, and process simulation all within one package.