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/

glomerular filtration rate (GFR)

deltaDOT’s Iohexol measurement assay is accepted by the International Renal Interest Society (IRIS)

Press release:  1st December 2019

The latest IRIS guidelines recommend the use of the glomerular filtration rate (GFR) assay developed jointly by the Royal Veterinary College (RVC) and deltaDOT

Nigel Stokes. deltaDOT’s Managing Director said “It is very good news that the work undertaken by RVC and deltaDOT in partnership since 2012 has now received industry approval. IRIS are an independent and highly respected society which carries great weight in the veterinary sector; we are delighted that they have given their approval for the use of our Capillary Electrophoresis based assay to measure GFR in dogs and cats.”

For details please visit the following link:

http://www.iris-kidney.com/education/gfr_in_practice.html

(The reference to deltaDOT can be found under point (7) of the “Plasma iohexol clearance” section.)

 

The Royal Veterinary College (RVC) publishes the results of 5 year comparison study showing how data from deltaDOT’s assay compares favourably against other commonly used diagnostic tests for kidney function in dogs (measurement of SDMA and creatinine).

deltaDOT’s Iohexol measurement assay is compared favourably against other methods for detection of reduced kidney function in dogs by an independent study

Press release:  14th November 2019

The Royal Veterinary College (RVC) publishes the results of 5 year comparison study showing how data from deltaDOT’s assay compares favourably against other commonly used diagnostic tests for kidney function in dogs (measurement of SDMA and creatinine).

Nigel Stokes. deltaDOT’s Managing Director commented “RVC’s publication shows how our advanced Capillary Electrophoresis instruments have been used to accurately measure Iohexol concentrations in canine serum over the past 5 years. This has enabled us to accurately and inexpensively calculate the GFR (Glomerular Filtration rate) of the dog much more accurately. GFR is considered by many to be the “gold standard” measure of kidney function. The benefit of using CE is because there is no need to remove the serum proteins as they can flow through the capillary. This is not the case for other commonly used techniques such as HPLC which require the proteins to be removed to avoid column blockage. When compared to traditional single point CE, the deltaDOT technology has further significant advantages as it used multi-pixel detection. Unlike traditional CE and HPLC instruments which measure the analyte peak with just one detector, the deltaDOT system uses 512 pixels. When the readings from all 512 pixels are averaged the accuracy of our data (in terms of quantitation) are significantly better than for other techniques. The greater precision of the Iohexol measurements at the time points enables deltaDOT’s instruments to more accurately calculate the Glomerular Filtration Rate (GFR).”

For further information on the above study, and to download the paper, please visit our Veterinary Diagnostics page at:

http://www.deltadot.com/publications/

deltaDOT welcomes Huazhong University of Science and Technology

Press release: 5th July 2019

deltaDOT was pleased to host a delegation from Huazhong University of Science and Technology today.

Nigel Stokes. deltaDOT’s Managing Director said “Now that deltaDOT has a partner in China which can support our technology, the opportunity was taken to outline how our novel technology could benefit the delegates’ businesses. We look to setting up collaborations between deltaDOT, our Chinese partner and businesses in China.”

deltaDOT was pleased to host a delegation from Huazhong University of Science and Technology

The text on the banner translates as “Visit to UK by CEOs studying at Huazhong University of Science and Technology”

Licensing of High Performance Capillary Electrophoresis Technology

deltaDOT are pleased to announce that they have licensed their High Performance Capillary Electrophoresis technology to a leading Chinese company.

On 29th December 2017, deltaDOT entered into a collaboration agreement with a Chinese partner to purchase all technical know-how, software and IP licenses for their High Performance Capillary Electrophoresis (HPCE) technology. This partner plans to provide locally manufactured HPCE instruments in China and offer domestic scientists, researchers and QC personnel a wider range of analytical choice. The deal involves an initial payment (now received) and two further milestone-related payments in the next 12 months.

deltaDOT’s partner has focused on the provision of food and drug testing to clients in the agriculture, chemical engineering and environmental protection sectors. While it has developed a great deal of expertise in chemical testing and reagents, this deal will further enhance its expertise in areas such as life science, medical diagnostics and biopharmaceutical analytics.

In the UK, Europe and the US, deltaDOT have worked to provide an alternative to traditional Capillary Electrophoresis (CE) technology by developing and commercialising a highly innovative bioscience instrument, the HPCE-512. This instrument solves the issues that limit traditional CE technology so allowing the full potential of this analytical technique to be realized. The HPCE-512 has many advantages compared to conventional CE, Mass Spectrometry and HPLC approaches owing to its patented multipoint detection technology, together with the proprietary signal processing algorithms. This innovative label free approach produces data with superior resolution, accuracy and repeatability compared to competing techniques, and at significantly reduced cost.

deltaDOT’s technology has found successful applications in detection, separation and analysis of proteins, antibodies, nucleic acids, carbohydrates, viruses and bacteria, drugs, chemicals and a wide range of other analytes.
Nigel Stokes, deltaDOT’s Managing Director, commented: “This agreement is a strong validation of deltaDOT’s label free technology. In the competitive analytical instrumentation sector it is very encouraging to see the adoption of our technology into the vibrant and rapidly developing Chinese market. We are very pleased to see an objective and international validation of our label free technology.”