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.
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...