It is an exciting time to work in Biotechnology! The Biotechnology manufacturing sector is on the leading edge of unprecedented expansion, with over $20 billion of new capital assets coming online over the next 3-5 years. This tremendous growth in manufacturing capacity is driven by the convergence of multiple factors, including:
Our capability to operationalize these investments and meet the growing patient demand for biologic products will strongly depend upon our ability to proactively identify emerging trends and constraints created from this growth and effectively collaborate together to solve common problems.
It is inspiring to work in an industry and at a time that has such potential to transform healthcare for millions of people.
The December, ISPE 2016 Biopharmaceutical Manufacturing Conference in beautiful San Francisco will bring together thought leaders, subject matter experts, service providers, suppliers, and Global Regulators to identify these emerging trends and share innovations being employed in the industry to deliver on our promise to supply life changing medicines to patients across the globe. This conference is a unique opportunity to focus on Biologics Operations, hear from industry leaders who are involved in Biopharma growth on a daily basis and learn about what your peers are doing right now. Education opportunities include:
I believe this conference is a fantastic opportunity to collaborate with industry leaders and peers on biotechnology manufacturing; and ensure we collectively fulfill this potential and our promise to patients. I look forward to seeing you all in San Francisco.
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...