Developing Bespoke Purification Strategies For Challenging Biologics: A Case Study

Downstream purification of biologics can be complex and is heavily dependent on the properties of the molecule. Where similar classes of molecules are manufactured regularly, platform processes and standard approaches can be useful; however, where biologics with unusual properties are involved, developing downstream purification processes can have unique challenges. Fujifilm Lifesciences develops manufacturing processes for a wide range of biologic molecules, from simple microbial proteins to complex mammalian multimeric proteins. This case study examines the challenge involved in developing a process for a particularly challenging molecule and transferring this process to large-scale cGMP manufacture.

Speaker: Christopher Fox, MSc Senior Technical Project Leader, Process Development, FUJIFILM Diosynth Biotechnologies