In the last decade, biopharmaceutical industries have had to mobilize quickly in response to pandemics. Developing vaccines and manufacturing large doses in an emergency is a challenge. The need to move quickly drives important innovations that help to compress the time. This webinar will delineate key considerations and perspectives on how vaccine processing could change to address future global health challenges, in addition to the evolution of vaccine production in response to pandemics and outbreaks.
The development of Celularity's therapies is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. The approach begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions.
Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.
Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.
Outsourcing a fill/finish project can be a challenging journey without a formal guide to the “right” path. Several key milestones along the way determine your outcome. This article will guide you through them.
Large molecules require special handling procedures for bulk drug substance, formulation, and sterile filtering and filling of the final drug product, forcing change on many levels of the manufacturing process.
Foaming can cause increased contamination risks through potential exhaust filter fouling, poor mass transfer, product/cell entrainment, increased shearing from bursting bubbles, and cell death.
Join this live discussion on the biopharma trends impacting your facility and business. BioPlan Associates’ Eric Langer will join FUJIFILM Diosynth Biotechnologies' Jonathan M. Haigh, Ph.D., and BioProcess Online’s Matt Pillar for an analysis of current events and a Q&A on development opportunities, hiring trends, new technology adoption, COVID-19, and more. Register.