From Lab to Commercial Production -How to Combat Challenges in OSD High Potency Products Development

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. 

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

Ensuring quality and compliance in bio-manufacturing Closing gaps in development data prior to the first GMP production Adjusting manufacturing processes throughout the course of a site-to-site transfer Fulfilling special requirements on container closure systems for biologics Transferring analytical methods for drug products and drug substances

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