21 CFR Part 11 and Annex 11’s purpose is to ensure electronic records and signatures are equivalent to paper-based records and handwritten signatures. Beyond proving equivalency, software used for electronic records and signatures offer benefits like access control, audit trails, data integrity, and easy search and retrieval of information.
Single-source manufacture of biopharmaceuticals is becoming more and more rare. Increasingly, biomanufacturers or “sponsor” companies partner with contract…
Collaboration between biomanufacturers and CDMOs often experiences challenges with data sharing. This presentation highlights the management of heterogenous and asynchronous data and how a data integration platform can improve project lifecycle data management, and collaborative data sharing.
In this webinar, you will:
•Understand the main drivers and benefits of closed processing in biopharma, including facility utilization, sustainability, cost reductions, and labor savings.
•Analyze biopharma facility design, comparing traditional layouts to innovative, modular, and ballroom-style configurations.
•Learn about industry guidance and best practices in the adoption of closed processing.
In this webinar, you will learn how our new single-use bioreactor family can help you:
– Fulfill any process strategy, be it batch, fed-batch or perfusion
– Facilitate scalability of your upstream process
– Utilize the flexible design to reduce production costs
Join us for this panel discussion to discover how a large global network of scientific experts, innovative technologies, and non-GMP facilities empower startups to advance scientific innovation through collaborative exploration and learning.
We invite you to the 4th Annual Biotech Start-up Symposium, a free, two-day event to help Biotech Start-ups navigate their path to commercialization.
Traditional scale-down models lack true perfusion capabilities, therefore not optimum for the perfusion media development process. Mobius® Breez microbioreactors with true perfusion capability are highly predictable to larger scale bioreactors, thus significantly enhancing our current workflow.
Click HERE to watch the On Demand Event. Abstracts Building a Successful mAb Platform using the CHOZN® Cell…
Great insights shared by market leaders at Pharma’s Almanac roundtable discussion. Click HERE to access the full summary.
