Articles

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from September 2019. Explore key insights for process innovation, distillation technologies, validation strategies, and more for what the pharmaceutical industry was reading last...

Celgene International II is the 2019 ISPE Facility of the Year Category Winner for Sustainability for their Green Fairy (La Fée Verte) in Couvet, Switzerland.

The world is getting smaller due in no small part to the technological advances. Pharmaceutical Manufacturing is moving in parallel with this trend—smaller batch sizes and personalized medicines are the trend on the horizon. But some producers, small has...

FDA’s efforts to continue streamlining approval pathways for medical devices was expanded when, on September 20, 2019, the Agency issued new Final Guidance as a means to help manufacturers understand how the Agency will determine substantial equivalence...

Zen-Zen Yen Venture Manager Bayer AG Zen-Zen Yen is a highly active Young Professional in the ISPE D/A/CH Affiliate who also is engaged in the...

The scientific community is well aware of the impacts of natural disasters. Hurricanes, earthquakes and wildfires have halted manufacturing processes and caused major drug shortages in the U.S. alone. In addition, the World Health Organization (WHO)...

The past few years have placed regulatory issues at the heart of our activities. Some of these issues include: EU/US Mutual Recognition agreement PIC/S Mutual Reliance Draft Guidances on Continuous Manufacturing but also on ATMPs These are all issues...

Pfizer Inc. is the 2019 ISPE Facility of the Year Category Winner for Project Execution for their Pfizer Global Technology Center in Hangzhou, China.

How do we best design a production facility for advance therapeutic medicinal products (ATMPs)? How about high-potent products that need to be sterile? And what are the latest developments in Barrier/Isolator technology? We will try to answer all these...

Pharmaceutical Engineering is delighted to announce the 2018 Roger F. Sherwood Article of the Year finalists. The articles were selected by the judges from 37 feature and technical articles published by Pharmaceutical Engineering during calendar year...

Falsified Medicines Directive 2011/62/EU was published by the European Parliament on 08-Jun-2011. The Directive was implemented to increase the security of the manufacturing and delivery of medicines across Europe, protect patients and prevent falsified...

The voice of one patient and a pandemic in South Korea in 2014 prompted a new approach to dispensing Investigational Medicine Products (IMP) -- bringing the medicine directly to the patient. The approach is in alignment with Sanofi R&D’s Corporate...

Adapting to new situations can be hard – new job, new city, new industry – change is rarely easy, and adapting to a new idea of ‘self’ can be even more challenging. We ask ourselves questions like am I good enough? What can I really contribute to the...

Featured in this edition of ISpeak Reading Roundup, are the top blog posts from August 2019. Discover key insights for data integrity, manufacturing excellence, innovative validation practices, and more for what the pharmaceutical industry was reading...

Eli Lilly and Company is the 2019 ISPE Facility of the Year Category Winner for Process Innovation for their IE2 Small Volume Continuous Facility located in Kinsale, County Cork, Ireland.

In 1988, the Oldsmobile automobile company attempted to rebrand themselves to appeal to a new generation of car buyers by introducing a marketing campaign that distanced itself from everything that it had stood for up to that point. The tagline line was...

Please join me at the 2019 ISPE Global Pharmaceutical Regulatory Summit, being held at the Bethesda North Marriott in Bethesda, Maryland December 5-6, 2019. The theme for this year’s summit is “Igniting Innovation in Development & Quality During...

Edwin L. Harmon, III Vice President of Engineering, Facilities and Validation LSNE - Contract Manufacturing Organization Edwin Harmon, Vice President of...

Design and construction of facilities and equipment using modern day information technology is common in today’s project execution. Comprehensive 3D modelling, component databases, scheduling and planning are all common place, almost to the point that...

ISPE sat down with Carmelo Rosa, PsyD, Director, Division of Drug Quality and Senior Officer of Compliance, FDA/CDER, and co-chair of the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference to discuss key event highlights and takeaways The...

The Asia Pacific (APAC) region is diverse in terms of its demographics. From the developed countries such as Japan, South Korea, Taiwan, Singapore, and Australia to emerging economy countries such as Thailand, Indonesia, Malaysia, Vietnam, Bangladesh,...