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ISPE D/A/CH Workshop: Data Science Assisted Biopharmaceutical Tech Transfer and Process Characterization

Process engineering and process quality in the pharmaceutical production.

Regulatory expectations for statistically underpinned Process Validation (PV) has found its way into current guidelines such as the FDA’s life cycle approach to process validation from 2011 leading to demonstrating Established Conditions (ECs) in ICH Q12.
However, specific critical components to successful and accelerated biopharmaceutical tech transfer along the life cycle and processes validation (Stage 1-3) remain unresolved in industrial practice. This is due to the necessity of using scale down models, cost intensive set up of experiments and the complexity due to the interactivity of a multitude of unit operations. Most of the tasks, such as risk assessment, scale down model qualification, experimental criticality assessment, setting of control strategies, PPQ number estimation, and Continued Process Verification (CPV) require statistically based rationales to meet regulatory expectations in terms of risk-aware decision making.
Additionally, next generation bioproducts, such as biosimilars and Advanced Therapy Medicinal Products (ATMPs) accelerate the demand of clear workflows towards an efficient process validation. The commonly accepted hypothesis is that sound data science approaches will be a success factor in this endeavour.

To focus the work, the 2020 Data Science Assisted Biopharmaceutical Process Validation Workshop will focus on the first part of the above tasks: Process Characterization Studies (Stage 1) Validation and Technology Transfer. It will focus on the contemporary and novel approaches to meeting Stage 1 Validation and Technology Transfer expectations and ensuring consistent product quality. Methods and best practices embedded in workflows based on data science will be presented interactively, using case studies and hands-on workshops that enable reduced experimental effort towards a robust process. Thereby reduced out-of-specification rates, accelerated time to market and lower manufacturing trouble-shooting costs can be achieved.

Datum und Zeit

27.05.2020 - 28.05.2020 iCal


Hochschule für Life Sciences FHNW
Campus Muttenz
Hörsaal 02.S.21


Hochschule für Life Sciences


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Hochschule für Life Sciences FHNW

Fachhochschule Nordwestschweiz FHNW Hochschule für Life Sciences Hofackerstrasse 30 4132 Muttenz
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