Scaling complexity without losing control: how manufacturing processes are adapting to the next generation of medicines (part II)

In conversation with Dr Kevin Robinson (KSR), Jakub Knurek (JK), Marketing Specialist at Mabion SA, discusses how early collaboration, smarter process control and carefully targeted technologies can support reliable biologics manufacturing.

KSR: As medicines and manufacturing processes become more complex, where are the biggest challenges when moving from development into scalable production?

JK: Complexity is the common thread. As antibodies evolve into bispecifics, antibody-drug conjugates and other engineered formats, the number of critical quality attributes grows … and so does the number of ways a process can drift between bench and commercial scale.

Regulatory expectations add another dimension: each scale-up decision must be supported by a sound control strategy and evidence that product quality, safety and efficacy are protected.

Fragmented development and manufacturing can make this harder, especially when knowledge is lost between technology transfers.