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 Biotechnologies develops manufacturing processes for a wide range of biologic molecules, from simple microbial proteins to complex mammalian multimeric proteins.

This webcast examines the challenge involved in developing a process for a particularly challenging molecule and transferring this process to large scale cGMP manufacture.

 Key Takeaways: 

• How molecule‑specific properties can limit the use of standard platform purification approaches.
• Strategies for developing robust downstream processes for particularly challenging biologic.
• Practical insights into scaling and transferring complex purification processes to cGMP manufacture.