Talking to Dr Kevin Robinson (KSR), Joanne Anderson (JA), Chief Commercial Officer at Symbiosis, explores the challenges of moving from development to commercial production, the opportunities to improve both control and reproducibility, and the role of specialist partnerships and emerging technologies when it comes to maintaining consistent quality.
KSR: As medicines and manufacturing processes become more complex, where are the biggest challenges when moving from development into scalable production?
JA: One of the biggest challenges is that science is advancing faster than the manufacturing infrastructure needed to support it.
Complex biologics, ADCs, mRNA products, cell and gene therapies and personalised medicines all introduce unique development and scale-up requirements that are rarely linear.
Processes that work successfully at laboratory or early clinical scale often become difficult to reproduce consistently as batch sizes increase and regulatory scrutiny intensifies.
At the same time, companies face growing pressure to conserve capital, shorten timelines and demonstrate commercial viability much earlier in development.
This means manufacturing decisions made during early development can have significant consequences later in the product lifecycle.
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