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:

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:

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:

(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:

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.”

deltaDOT are launching a new series of articles dD Techniques on the  capabilities of their High Performance Label Free Imaging Capillary Electrophoresis technology.

8 September 2017  The articles offer accessible information and an insight into this unique technology which is used  worldwide to solve challenging analytical problems. A new perspective on the tools required for  the development and manufacture of monoclonal antibodies, biosimilars, stratified therapies,  viral vaccines and gene therapy vectors highlights the need for new analytical techniques.  These new perspectives are the aims which dD Techniques articles intend to deliver to a wide audience (…links to article1article2article3)

UCL Advanced Centre For Biochemical Engineering

For more information on the Hub, collaboration and how to join the industrial User Group please contact: Dr. Naveraj Gill, Strategic Alliance Director, Deputy Head of Department (Enterprise) e: , t: +44 (0) 203 549 5619

Future Targeted Healthcare Manufacturing Hub

Bio-manufacturing solutions to transform healthcare precision in the bio-therapeutics sector UCL Biochemical Engineering has an outstanding track record and is a world leader in bioprocess research across a range of sectors. UCL’s Future Targeted Healthcare Manufacturing Hub engages leading academics across the
UK as Spokes. This national asset is valued in excess of £20M over 7 years (2017–2024).

The Hub will address the manufacturing, business and regulatory challenges to ensure that new targeted biological medicines can be developed quickly and manufactured at a cost affordable to society.

The research will span stratified protein medicines targeted to particular patient groups through to truly personalised cell-based medicines.
The Hub is unique in the bio-manufacturing space, and is being supported by a large number of the leading manufacturers and suppliers in the biotherapeutics industry and non-governmental associations.

Click to download the brochure


Featured in the Technology Partnership Publication tpp

The Technology partnership publication ( now includes key facts  and data on deltaDOT’s High Precision Capillary Electrophoresis advanced technology. The TTP  Journal of Technology and Business Innovation provides technical insight into UK advanced scientific businesses

Achieving the full potential of Capillary Electrophoresis using superior signal processing techniques derived from astro and particle physics.

deltaDOT’s core technology, Label Free Intrinsic Imaging (LFII®), allows the direct monitoring of unlabelled biomolecules during the analytical separation process. This results in faster, higher quality results at a fraction of the cost of conventional Capillary Electrophoresis (CE) techniques.

Click to download



24th January 2017

deltaDOT software enables users to comply with the FDA’s data requirements London, UK, 24th January 2017 – deltaDOT Ltd announced that: By working with external consultants, deltaDOT now offers an upgraded version of its control and analysis software which has been designed to aid users in achieving compliance with CFR 21 part 11 from the USA’s Food and Drug Administration.

This package contains technical controls to help meet requirements including checks to ensure that only authorised users can access the system, maintaining audit trails of user actions, generating complete and protected data files and the application of electronic signatures to data. Nigel Stokes, deltaDOT’s Managing Director commented that “We worked with a firm of external consultants (Optra Systems) for over 6 months on software validation relating to the above CFR standard. The aim of the exercise was to ensure that our software provided the tools which our clients need to comply with the regulations, to check that all data produced by the system could be validated, and to put a Quality Management System in place to control any future changes to the software. We are very pleased that this work was completed on time and within budget.” Dr Stuart Hassard, deltaDOT’s Chief Scientific Officer added that “With these new software tools we are enabling the use of our technology throughout the bioprocess, and are allowing our clients to make higher quality products using our cost effective process analytical technology. Recent advances in monoclonal, biosimilar and gene therapy viral vector characterisation have greatly increased the range of valuable applications which our instruments can address.” About deltaDOT Ltd deltaDOT has developed and commercialised highly innovative Life Science instrumentation. The analytical technology is based on an innovative approach to Capillary Electrophoresis. deltaDOT’s patented multipoint sensor system together with the proprietary computing algorithms gives superior resolution, accuracy and repeatability compared to similar laboratory instruments. Successful applications of the technology have been found in detection, separation and analysis of proteins, nucleic acids, carbohydrates, viruses and bacteria, drugs, chemicals and a wide range of other analytes. deltaDOT now sells the HPCE-512 instrument (pictured below) which is the value engineered version of the company’s previous product. The HPCE-512 has many improved features such as optional carousel cooling for the samples; the accurate temperature control of samples awaiting analysis is a requirement for high end characterisation work done for example by pharmaceutical clients. Find out more about deltaDOT Ltd at

National Health Service Quality Control North West

20 Sep 2016 (QCNW) Liverpool labs presented the data on monoclonal antibody stability trials based on deltaDOT’s Capillary Electrophoresis (CE) technology and expertise. They state that CE technology is suitable for monitoring the stability of monoclonal antibodies and can perform purity and charge analysis with high resolution and repeatability. They conclude that CE can replace other techniques commonly used for this analysis IEC and SDS PAGE (link to the poster).

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