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Day One Recap of the 2019 ISPE Annual Meeting & Expo Change is a constant in the pharmaceutical industry. Improving the ways in which the industry changes can help develop and deliver therapies to patients. Speakers at the Opening Plenary of the 2019...

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 Pelletier. The article explores the promise...

Pharmaceutical companies deal with challenges and unexpected issues that touch every aspect of the business. While tending to the demands of stringent compliance requirements and production schedules, other priorities such as improving process stability,...

Takeda is one of two 2019 Facility of the Year Award Honorable Mention Winners for their Georgia Manufacturing Facility project in Social Circle, Georgia.

Conference Essentials Conference AgendaTravel Information Registration and Information Days/Hours Saturday, 26 Oct | 1300–1700 Sunday, 27 Oct | 0700–1800 Monday, 28 Oct | 0700–1730 Tuesday, 29 Oct | 0700–1730 Wednesday, 30 Oct | 0700–1300 Expo Hall...

Introduction Patients are demanding more innovation from drug companies for delivery of therapeutics, ease of use, and affordability. Combination Products are integral to our industry. Per the Globe Newswire Global Forecast, the Drug Device Combination...

In just a few short days, people will gather from all over the world in Nevada for the 2019 ISPE Annual Meeting & Expo to focus on modernization, globalization, and transformation in pharmaceutical science and manufacturing across the globe, offering...

Las Vegas, the city that holds picture perfect moments, outdoor adventures, concerts, exceptional fine art, and so much more, will host the 2019 ISPE Annual Meeting & Expo! Famous for its history as a vacation destination, there is no doubt that you’ll...

Advancing Pharmaceutical Quality continues to be a hot topic as industry sees the benefit in an industry-for-industry program to advance continual improvement. FDA is reflecting on the messages it is hearing in response to the 2018 Federal Register...

AveXis is one of two 2019 Facility of the Year Award Honorable Mention Winners for their Next-Generation Manufacturing Facility for a Next-Generation Medicine Project in Chicago, Illinois.

ISPE’s Facility of the Year Awards is the premier global awards program recognizing innovation and creativity in manufacturing facilities serving the regulated healthcare industry. The award-winning projects selected by the Facility of the Year Awards...

On- and in-line analysers are used in the framework of PAT (Process Analytical Technology) for controlling and monitoring unit operations in pharmaceutical operations for both batch and continuous manufacturing. The most basic requirement to utilize this...

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)...