- Integrated batch processes in API manufacture: Model-based impurity tracking to design robust control strategies
- Integrated batch processes in drug product manufacture: Model-based design space exploration of tablet quality
Integrated batch processes in API manufacture: Model-based impurity tracking to design robust control strategies
In recent years, mechanistic models have been applied to a broad range of drug substance manufacture applications in pharmaceutical R&D and Engineering, improving efficiency through reducing experimental requirements, facilitating scale-up and tech transfer, and enabling virtual design space exploration.
The use of mechanistic models to aid design and operation of continuous manufacture is well known due to regulatory and industry trends. This webinar will demonstrate how gPROMS FormulatedProducts can be used to track the evolution of impurities across multiple batch drug substance manufacture operations and how it can be used to predict the quantitative behavior of the processes and design robust control strategies to minimize risk associated with impurity formation.
While many drug substance manufacture applications of mechanistic models focus on a single unit operation, integrated or system models describe all processing steps, enabling a holistic, quantitative assessment of the effects of process parameters on critical quality attributes, such as impurity formation and rejection.
What this webinar covers
- Why models of integrated drug substance manufacture processes are beneficial to explore design decisions and assess risk with respect to process impurities,
- Application of a flowsheet model to track evolution of impurities throughout an integrated batch drug substance manufacture process including reactions, liquid-liquid separation and crystallization steps,
- How new features in gPROMS FormulatedProducts enable simulation and sensitivity analysis of batch drug substance manufacture flowsheets
- Identify opportunities to maximise the purity of drug substance(s) produced, and
- How upstream disturbances and process parameters affect downstream process behavior and product performance (nominal values and their variability).
Who should attend?
Those with an interest in drug substance manufacture and tracking/control of impurities, from non-modellers to expert modellers.
When
14 July 2021, 10:00 EDT/ 15:00 BST
Duration
30 minutes plus Q&A
Presenter(s)
Dr Niall Mitchell is a Principal Consultant and Practice Director for the Active Ingredient Manufacture modules of gPROMS FormulatedProducts. He is a Chemical Engineer with a PhD on the mechanistic modelling and experimental aspects of crystallization from the University of Limerick. Niall has over ten years of industrial experience in reaction & fluid separations, crystallization, size reduction & solid processing and is responsible for the development & application of Siemens PSE’s tools in this area.
Integrated batch processes in drug product manufacture: Model-based design space exploration of tablet quality
In recent years, mechanistic models have been applied to a broad range of drug product manufacture applications in pharmaceutical R&D and engineering, improving efficiency through reducing experimental requirements, facilitating scale-up and tech transfer, and enabling virtual design space exploration.
The use of mechanistic models to aid design and operation of continuous manufacture is well known due to regulatory and industry trends. This webinar will demonstrate how gPROMS FormulatedProducts can also be used to build models of integrated batch drug product manufacturing processes and how it can be used to describe and predict the quantitative behavior of pharmaceutical processes.
While many pharmaceutical applications of mechanistic models focus on a single unit operation, integrated models describe a full process line, enabling a holistic, quantitative assessment of the effects of process parameters and material attributes on critical quality attributes. Such integrated models are typically associated with continuous processes and are constructed through flowsheet modeling. However, using these same methodologies, integrated flowsheet models of batch processes can be constructed and applied to improve process and product design, risk assessment, and control strategy design and evaluation.
What this webinar covers
- Why models of integrated batch drug product manufacturing processes are beneficial to explore design decisions and assess risk,
- Industrial applications of flowsheet models for batch drug product manufacture,
- How new features in gPROMS FormulatedProducts enable simulation and sensitivity analysis of batch drug product manufacture flowsheets, illustrated through a dry granulation, tableting, and coating example,
- How upstream disturbances and process parameters affect downstream process behavior and product performance (nominal values and their variability).
Who should attend?
Those with an interest in drug product manufacturing, from non-modellers to expert modellers.
When
21 July 2021, 10:00 EDT/ 15:00 BST
Duration
30 minutes plus Q&A
Presenter(s)
Dana Barrasso is a Principal Consultant in the Formulated Products business unit at Siemens Process Systems Engineering. As Siemens PSE’s Strategy Director for Pharmaceuticals, she is the technical lead for collaborative and strategic activities with industry, academia, and regulatory bodies in the synthetic pharmaceuticals sector. Her responsibilities include acting as the technical director for the Systems-based Pharmaceutics Alliance, a collaborative project between Eli Lilly, GSK, Pfizer, Roche, Sanofi, Bayer and Siemens PSE aimed at developing the tools and workflows that enable systems-based approaches to drug product and process design. With a PhD from Rutgers University, Dana’s background is in solids process modeling, with a focus on wet granulation processes. With this experience, she leads the development and application of Siemens PSE’s offerings in drug product manufacture, including continuous direct compression, wet and dry granulation, and tableting.
