Concurrent purification approach could cut ADC manufacture by 25%, ADC Bio
The Wales, UK-based contract manufacturing organisation (CMO) is yet to have given the process a name but says it undertakes bioconjugation for antibody-drug conjugates (ADCs) after both the monoclonal antibody (mAb) and cytotoxic have been manufactured, with purification of both carried out simultaneously.
According to ADC Biotechnolgy CEO Charlie Johnson, this represents a manufacturing paradigm by integrating several downstream methods and thus reducing the number of CMOs involved in the supply chain.
He added this will “save several months of manufacturing time and up to 25% of the overall costs.”
Mimicking Protein A
But another cost-saving factor is this approach uses ADC Bio’s ‘Lock-Release’ technology, which does not rely on Protein A capture resin, Johnson told this publication.
Protein A is deemed the gold standard for monoclonal antibody capture, but with a price tag as high as $12,000 per litre, it can account for a large percentage of the total bioproduction cost.
“ADC Bio does not use Protein A – instead, we use mimetic resins which mimic Protein A resins,” Johnson said.
“These mimetic resins have the benefit of being cheaper to make than Protein A and also have the distinct advantage of not leaching Protein A. Leaching is a significant industry problem with Protein A usage.”
He estimated that by not using Protein A, mAb makers can make savings of between 25% and 30%.
“Not only are you saving money by removing the need for the Protein A step, but also time and costs in the downstream processing.”