deltaDOT Bioprocess Technology Used for Regulatory Study

deltaDOT Ltd (London) can announce that its advanced bioprocess technology, the
HPCE-512, has been used in a regulatory study undertaken by the UK’s National Health Service
(NHS). Our client, Quality Control North West (Liverpool), is a division of the NHS which conducts
regulatory studies for the pharmaceutical industry. QCNW used deltaDOT’s HPCE-512 technology to
perform stability studies on a mAb biosimilar to allow it to be approved for human use.

For more information about the study please visit:

http://gabi-journal.net/extended-stability-of-the-trastuzumab-biosimilar-abp-980-kanjinti-in-polyolefin-bags-and-elastomeric-devices.html

The data produced by deltaDOT’s HPCE-512 (relate to the stability of the mAb once formulated
into saline solution) can be seen in Figures 3,4 & 5 of this document.

The role of deltaDOT as a specialist bioprocess R&D partner to QCNW is outlined on their website. Click here to read.

More information about deltaDOT capabilities to analyse mAbs can be found on the deltaDOT
website at:

http://www.deltadot.com/monoclonal-antibodies-profiling-mabs/