Arul Ramadurai (AR), Chief Commercial Officer at Axplora, tells Dr Kevin Robinson (KSR) how specialist expertise, early collaboration, targeted technology investments and robust process understanding support the reliable scale-up of increasingly complex medicines.
KSR: As medicines and manufacturing processes become more complex, where are the biggest challenges when moving from development into scalable production?
AR: The biggest bottleneck is often expertise. Facilities and equipment are essential, but biopharma companies need partners who can translate complex chemistry into a process that reliably operates at industrial scale.
In small-molecule API manufacturing, a successful development process is an important starting point.
Commercial production also requires scale-up, acceptable yields, manageable cycle times, effective purification and equipment suited to the chemistry.
Highly potent compounds add demanding containment requirements.
All of this calls for development scientists, industrial chemists and separation specialists to work together early.
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