The technology – PDReady – is a suite of systems designed to accelerate the development of monoclonal antibodies (MAb), covering all stages from culture clarification to production of the final bulk drug substance.
The idea is that combining these systems will save manufacturers time, according to Chase Duclos-Orsello, downstream processing technical consultant at Merck Millipore told in-Pharmatechnologist.com how the firm’s approach differs from traditional methods.
“In many cases MAb process developers will evaluate multiple vendors, multiple product options from each vendor and multiple operating conditions such as flow rate or pressure for each product at each step in the process. This leads to a large matrix of experiments.”
Chase Duclos-Orsello said that - in contrast – because Merck Millipore’s new kit is based on a proven purification template, the process development activity can be reduced to evaluation of a single product and a limited number of operating conditions for each unit operation.
“This drastically reduces the number of experiments to be done and significantly saves time and feedstock requirements at this scale. This can be done because Merck Millipore's extensive experience in MAb production has led to the creation of a complete purification template.”
He rejected the idea that the new kit is a marketing ploy to allow Merck Millipore to sell several products at once, arguing that the offering goes some way beyond a simple suit of technologies.
“This is a genuinely integrated offering in that it combines many products which are currently only available individually. It also includes the loaning of equipment, the provision of protocols, andconsultative support which was not previously a part of any offering.