Bioprocess International

There’s more to single-use than switching to bags, says Amgen

By Fiona BARRY

- Last updated on GMT

Single-use and "adaptive" manufacturing goes beyond fermentation tanks, says Amgen
Single-use and "adaptive" manufacturing goes beyond fermentation tanks, says Amgen

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Changes to biologics manufacturing will have to go beyond swapping steel vats for single-use to adapt to future industry needs, says Amgen’s drug development expert.

Large molecule makers must apply “adaptive manufacturing​” to all aspects of production, from filling and labelling to visual inspections and remote monitoring, said Ranjit Sarpal, principal scientist, drug product development, at Bioprocess International conference, which kicked off in Boston on Tuesday.

Sarpal said the anticipated future pressures from biosimilar competition and healthcare reform, as well as continued high-variation, low-volume orders, will all drive industry towards adaptive and single-use tech.

Single-use fermentation equipment is widely acknowledged to have a quicker turn-around (around eight to ten hours per batch) than stainless steel and to allow more flexibility for sites to switch between product lines. Sarpal added that it also has a smaller footprint – switching from traditional methods reduces a plant’s consumption by two-thirds, he claimed, although it does incur high upfront capital costs.

Beyond bags: adaptive manufacturing

Sarpal stressed the usefulness of adaptive, remote monitoring for facilities of the future, to provide centralised process development support for manufacturing networks. Remote sensing and collaboration can enable PD groups working from afar, and reduce on-site process development support, monitoring, and travel costs, he said. Real-time information on deviations, via remote visualisation (“in the style of Google Glass​”) can limit product impact, he added.

Filling and inspections are another area that can benefit from adaptive production, Sarpal claimed. Robotic fillers which can switch between different lines and container types are better than dedicated vial and syringe lines, he said. Flexible filling stations reduce facility footprint, capital and labour, and also allow companies a lower-cost, lower-risk way of entering emerging markets and refitting existing plants.

Meanwhile, visual inspections can in part be taken over by “a single adaptive automated visual inspection machine;​” a cost-effective investment for vials, syringes, and cartridge inspection, said Sarpal. He recommended sticking to manual visual inspection for the smallest volume lines.

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