Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2019. See leading facilities, break-through therapies, innovative technologies, and more for what the pharmaceutical industry was reading in October.
Learn more about how modular and podular construction designs can shape facilities of biopharmaceutical manufacturing. These facility designs can have the ability to address the severity of natural disasters and the impact on vulnerable populations globally.
This year’s category winner proved excellence in the incorporation of novel technologies, improved efficiencies, and success in eliminating challenges. Read more about Pfizer’s first modular biological production facility!
See the updates and new changes to EU Clinical Trial Regulation, including a single approach for the application and maintenance of the CT authorisation and this applies to trials whether they are multi-member state or mono-state.
Review current challenges validation experts are facing when implementing programs for advanced manufacturing. Key ideas addressed are continuous validation techniques and multi-step production challenges.
Discover how AveXis overcame challenges in execution and delivery of novel treatments for patients affected by rare and life-threatening neurological genetic diseases. The company received an Honorable Mention Award for this year’s competition.
The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...