Accelerating Biologics Through the Clinic: A Seamless Development-to-Manufacture Approach

Abstract

Biopharma companies are constantly looking for ways to accelerate time-to-market with minimal operational impact. Yet, when it comes to development, manufacturing and clinical supply of a biologic drug, they face challenges to increase productivity, reduce cost, mitigate risk, and optimize timelines to bring products to market faster. However, having the support of an integrated approach can minimize the impact of these issues However, these issues can become less challenging with the support of an integrated approach. A comprehensive end-to-end solution from biologics development, clinical to commercial-scale manufacturing, and finished product supply has higher quality and improved yield of biopharmaceuticals with reduced cost and time. This event will focus on key considerations for transitioning a molecule from clinical to commercial, beginning with cell line development and biomanufacturing, to formulation and filling and managing clinical trial supply.

Key learning objectives

• Learn the challenge of executing a DS to DP workflow needed to support all the different aspects of development and manufacturing.
• Learn how to develop an effective CMC strategy for a biologic product
• Understand how early integration of clinical supply chain services can lead to speed and cost savings

Time: 8:30 am – 11:00 am CET
Location: Medicon Valley Alliance, Copenhagen, Denmark