November / December 2019

Eric S. Langer
Features
Biopharma Growth Trends: More Innovation on the Way
Innovation has been and continues to be a driver for the strides being made in biopharma development and manufacturing, noted Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., who addressed “Innovation in Transformative...
The Future of Biopharma: What Does the Industry Want and Need?
InTouch
The Future of Biopharma: What Does the Industry Want & Need?
What Does the Industry Want and Need? Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., shared these most-needed cell and gene therapy manufacturing improvement, systems, platforms, and infrastructure from his company’s...
Comparison of electricity consumption at the main distribution board
Technical
Airflow Reduction in Cleanrooms after Closing Hours
Cleanrooms and laboratories can save a significant amount of energy by reducing airflow of air handling units (AHUs) after closing hours. Although challenging, airflow reduction is a successful energy reduction measure and has been implemented within the energy reduction program of Janssen Vaccines...
Accreditation organizations’ systems to show online pharmacy legitimacy
Technical
Regulating Online Pharmacies & Medicinal Product E-Commerce
The internet has led to an increase in e-commerce of prescription and over-the-counter (OTC) medicinal products; one in four adults has purchased medicines online.Orizio, G., A. Merla, P. J. Schulz, and U. Gelatti. “Quality of Online Pharmacies and Websites Selling Prescription Drugs: A Systematic...
Article
InTouch
ISPE Briefs - Special Interest Group Formed for Artificial Intelligence
ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial Intelligence Special Interest Group was formed under GAMP®. A conversation with Eric Staib, Vice President of Compliance and PVAI Compliance Officer...
Tracy Clemmer
Insights
Multiple ISPE Roles: Lead to Unlocking Potential
Tracy L. Clemmer’s experience has spanned the globe, and she has an impressive list of ISPE roles on her résumé. In addition to being a past President and Chair of the Training and Education Committee of the ISPE Singapore Affiliate, she was a Board Member and Chair of the Training and Education...
Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
Features
Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...
Article of the Year Logo
Features
Continuous Manufacturing in Biotech Processes
Article of the Year 2018 Winner: The winner of the 2018 Roger F. Sherwood Article of the Year award is “Continuous Manufacturing in Biotech Processes: Challenges for Implementation” by Robert Dream, PE, CPIP; Christoph Herwig, PhD; and Emilie...
Industrializing New Platforms
Features
Industrializing New Platforms
Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the 2019 ISPE...
Practical Regulatory and Industry Panel
Features
Practical Regulatory & Industry Issues
Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing Conference.