Data Science for Pharma 4.0™, Drug Development, & Production—Part 1

About the Author

Senior Scientific Advisor

Körber Pharma Austria

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to enter his interdisciplinary PhD...

Frank B. Nygaard, PhD

CMC Director, Drug Substance Development

Symphogen

Frank Nygaard has more than 14 years of R&D experience from the biotech industry with a broad background within manufacturing and analysis of protein therapeutics...

Michelangelo Canzoneri

Global Head of Group Smart Manufacturing

Merck KGaA Darmstadt, Germany

Michelangelo Canzoneri, PhD, serves as the Global Head of Group Smart Manufacturing at Merck KGaA, based in Darmstadt, Germany. A seasoned leader in digital transformation...

Stacy L. Springs

Biomanufacturing Program Director

MIT Center for Biomedical Innovation

Stacy L. Springs is the Senior Director of Programs at that Massachusetts Institute of Technology (MIT) Center for Biomedical Innovation and the Executive Director of...

Jacqueline M. Wolfrum

Codirector of Biomanufacturing@MIT-CBI

MIT Center for Biomedical Innovation

Jacqueline M. Wolfrum is the Codirector of Biomanufacturing@MIT-CBI at the MIT Center for Biomedical Innovation. She also directs BioMAN, an industry-academic consortium focused on innovations...

Richard D. Braatz, PhD

Edwin R. Gilliland Prof of Chemical Engineering

Novartis-MIT Center

Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at the Massachusetts Institute of Technology (MIT) where he does research in the...

Stefan Robert Kappeler

Technology Manager Life Sciences

Exyte Management GmbH

Stefan R. Kappeler works at Exyte as Senior Director Biopharma & Regulatory. He received his PhD in molecular biotechnology from the Swiss Federal Institute of...

Valentin Steinwandter

Werum

Valentin Steinwandter currently leads the inCyght software group at Werum (previously named Exputec). The software allows use of high amounts of biotechnological process data from...

Technical

Risk- And Science-Based Media and Buffer Mixing Validations

1 March 2024

The validation of media and buffer mixing is a continuing area of resource constraint in the pharmaceutical industry. These validations require materials, validation associates’ time, and the use of equipment and processing areas. This article proposes a risk-based life cycle for minimizing mixing validation resource inputs, with the objective of optimizing validation efforts through the use...

Features

Digital Display Labeling in Clinical Supplies for Clinical Trials

1 March 2024

Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

Features

Evolving China’s Regulatory System in Alignment with ICH

1 March 2024

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

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