Overcoming Challenges in Transferring a Sterile Biologics Drug Product to a CDMO

In our packed out content sessions at CPHI Barcelona this year we focus on some of the hottest topics coming up in the pharma industry, with each track sponsored by a leading expert in the field. 

Highly Potent APIs are a rapidly growing segment of the global pharmaceutical industry, and they are acquiring a significant relevance into the development space. The importance to understand the challenges around development of High Potency Oral solids formulations, are the key to ensure a right scale-up and launch Risk-based approach: measuring the risk, not the hazard Challenges for High potency products handling. Importance of select the adequate partner Development of secure and scalable process in high containment environment

Hameln plant which provides fill and finish for Pfizer-BioNTech COVID-19 shot should be fully operational within the week, CDMO says

The Covid-19 Pandemic forced us to learn new ways of collaborating and innovating to solve a global crisis - what can we learn and leverage from this experience as we adapt to a 'new normal'?
Amazing scientific development and break-throughs are evolving faster than ever, with new advanced treatment options for patients being developed at unprecedented speed. All of us involved in manufacturing and supply need to rethink how we collaborate, deliver medicines and learn faster.
No one company can solve this alone - requiring us to collaborate, innovate and learn in new ways. What does this change really mean for us? Welcome to engage in a discussion, sharing case study data and recent insights in the middle of an industry learning journey.

Though viral vectors are used extensively in cell and gene therapy, the challenges of manufacturing such complex biologics at industrial scale is still a limitation to its broader use.
Dr. Ayuso will speak about how upstream and downstream process optimization using design of experiments (DOE), a platform approach and end-to-end capabilities can tackle manufacturing challenges and help to expedite drug development.

Join Asklepios BioPharmaceutical's former CEO Shelia Ann Mikhail, where she will Set the Scene for the latest innovations and developments affecting the Biomanufacturing Landscape

The Covid-19 Pandemic forced us to learn new ways of collaborating and innovating to solve a global crisis - what can we learn and leverage from this experience as we adapt to a new normal? Amazing scientific development and break-throughs are evolving faster than ever, with new advanced treatment options for patients being developed at unprecedented speed. All of us involved in manufacturing and supply need to rethink how we collaborate, deliver medicines and learn faster.
No one company can solve this alone - requiring us to collaborate, innovate and learn in new ways. What does this change really mean for us? Welcome to engage in a discussion, sharing case study data and recent insights in the middle of an industry learning journey.

Manufacturers face unique quality challenges that can hinder progress. In this session, discover quality challenges in Cell and Gene Therapy (CGT) and learn common practices for overcoming them:
Where are all the approvals? Understanding unique manufacturing challenges for Autologous Cell Therapies How does development by design, quality by design, and Cell Therapy COGs converge in this new space? Creating a Cell Therapy technology roadmap to address challenges and drive speed-to-market