The 2023 ISPE Biotechnology Conference will focus on the overarching themes that represent learnings from the originator pharmaceutical products that can be applied and transferred to the (new) biosimilar and follow-up biotechnology products. Methodological enablers for process development, supply chain resiliency, and more critically, driven by the energy crisis, sustainability will be the primary focus of our event. Discussions will be presented and considered within the current regulatory framework.
The focus is on different challenges for innovative, biosimilar, and follow-up biotechnology products, like cell and gene therapy, Advanced Therapeutic Medicinal Products (ATMPs), and mRNA-based products - such as vaccines. The conference will feature presentations with a focus on time to market, shortened submission approval times, product transfer, new concepts for control strategy, quality oversight, manufacturing, and logistics.
