Featured in this edition of iSpeak Reading Roundup, are the top blog posts from July 2019. See trending ideas for regulatory compliance, biopharmaceutical innovation, and more for what the pharmaceutical industry was reading last month.
Explore the innovative software that will change the future of bioprocess planning and data collection. The bioprocess digital twin is a mathematical model that utilizes current manufacturing data and can better predict process chain outcomes.
Process verification and validation methods are crucial for any organization’s success with today’s complex supplies and equipment. See how continued process verification can help the industry avoid challenges and optimize the potential for regulatory compliance.
Hear from Robert Beall as he shares why process validation and the lifecycle approach are critically important for reliable manufacturing, product sustainability, and quality assurance.
Read about key details to new CT application, timelines, and requirements for the application process of EU clinical trials. Updates and additional information for the EU Clinical Trial Regulation are featured in this article.
Discover the impact of cutting-edge technologies, new production methods, and the latest advancements towards the future of biopharmaceutical manufacturing. This article highlights topics discussed at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston.
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...
ISPE hosted more than 450 attendees in person and virtually for the 2024 ISPE Aseptic Conference in Vienna, Austria. Keynotes and education sessions provided a comprehensive overview of key topics and trends...
Biopharmaceutical facility design is a critical aspect of the industry. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among...