Quality & Regulatory Solutions for PAT in Continuous Manufacturing

About the Author

Senior Manager, Strategy Deployment and Excellence, PQM

Janssen Supply Group LLC

Gabriella Dahlgren, PhD, oversees a team that manages stability for the Janssen SM portfolio. She has been part of the Global Janssen Product Quality organization...

Kevin A. Macias

Student

St Louis College of Pharmacy

Kevin A. Macias, RPh, PhD, obtained a BS in pharmacy from St. Louis College of Pharmacy and a PhD in industrial and physical pharmacy from...

Antonio R. Moreira, PhD

Vice Provost, Academic Affairs

University of Maryland

Antonio (Tony) R. Moreira, PhD is Vice Provost for Academic Affairs at the University of Maryland, Baltimore County (UMBC) and is responsible for academic affairs...

Duncan R. Thompson

PAT Team Leader

GSK

Duncan R. Thompson has 25 years of experience in analytical chemistry and PAT, leading a team at GSK that developed and implemented many PAT ap-plications...

Christoph Herwig, PhD

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...

Robert Dream, PE, CPIP, PhD

Managing Director

HDR COMPANY LLC

Robert Dream is an industry leader with more than 29 years’ experience, including 15 years of executive leadership experience, in the consumer product, pharmaceutical, biotechnology...

Technical

Selection Criteria for Pharmaceutical Containment Equipment

1 March 2024

Pharmaceutical manufacturing facilities produce a variety of products, including highly potent products that require safety measures to prevent adverse health effects on patients and operators. To ensure safety, these facilities use containment equipment to minimize the risk of contamination. This article presents criteria for selecting containment equipment, considering both...

Technical

A Sustainable Approach to Steam Quality Management

1 March 2024

The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon neutrality, by 2050. Many countries have committed to achieving this ambitious goal. As a major global industry, the pharmaceutical sector has a significant role to play. For thermal energy–intensive industries, such as pharmaceutical manufacturing, the long-term future options to maintain...

Technical

Concluding Compliance Challenges with Validation 4.0

13 March 2024

As the pharma industry moves to an ambitious Validation 4.0 paradigm, computerized systems play a pivotal role in enabling the rapid transition. Innovation and agility in computerized system validation (CSV) received a strong push in the second half of 2022 with the publication of the FDA draft guidance on “Computer Software Assurance for Production and Quality System Software”

About the Author

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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

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