Scope of Quality Management System extended.

25th July 2016

Abingdon Health announces the registration of its manufacturing facilities as GMP compliant, with the U.S. Food and Drug Administration (FDA), for the design, development and manufacture of lateral flow devices, and device readers for in vitro diagnostic medical use.

In addition, the Company’s Quality Management System certification encompassing ISO 9001:2008, ISO 13485:2003 and ISO 13485:2012, has been further extended to cover the design, development and manufacture of lateral flow devices, ELISA kits, reagents and device readers for in vitro diagnostic medical use.

The first product to benefit from this enhanced regulatory environment is the newly available lateral flow immunoassay reader – ADxLR5® which is now registered with the FDA and CE marked as a Class 1 Medical Device. The ADxLR5® has been developed as a next generation technology designed to offer the user the most up to date features required for the most complex quantitative lateral flow applications as well as the benefit of touch screen technology, barcode scanning and enhanced connectivity features.

The launch of the ADxLR5® will support the growth and expansion of the Abingdon Health multiple myeloma assays: Seralite®-FLC serum and Seralite®-FLC urine. In addition, the ADxLR5® will also be provided as an OEM reader solution for those customers wishing to have a bespoke reader developed alongside the development of lateral flow assays. Using their core expertise Abingdon Health are now able to offer the complete solution to OEM customers to deliver lateral flow assays and customised state of the art readers suitable for sale in USA, European and other markets.

Marsha Leeman, Quality and Regulatory Affairs Director said “The registration of our manufacturing facilities as GMP compliant reaffirms Abingdon Health’s commitment to making the groups Quality Management system integral to the company’s core business principles both for our own assays and also for our OEM customers”

Fiona Kilvington, Head of Sales and Marketing, said: “The availability of the ADxLR5® Reader for our customers will provide improved connectivity and traceability features with unique icon driven software providing workflow solutions for our own assays: Seralite®-FLC serum and Seralite®-FLC urine. Furthermore, we understand that this is an important solution for our OEM customers and GMP compliance will enable the development of lateral flow assays and reader solutions suitable for the USA market.”

Enquiries:

Abingdon Health Ltd +44 1904 406 082

Chris Yates CEO

Fiona Kilvington, Head of Sales and Marketing

About Abingdon Health – www.abingdonhealth.com

Abingdon Health Ltd is a UK-based in-vitro diagnostic group focused on developing a range of rapid testing products in the area of haematology-oncology. The Company launched its first rapid testing product in 2016, Seralite®– FLC, a rapid diagnostic device in multiple myeloma, and is in the process of launching a range of complementary rapid tests.

The Company’s core expertise lies in the development, manufacturing and commercialisation of rapid lateral flow immunoassay diagnostics and reader systems. To support its strategic plan Abingdon is currently working with its partner Sumitomo Chemical Co., Ltd on the development of a multiplexed immunoassay system for the rapid testing market. This device uses printed electronics technology-based components for versatile and quantitative optical detection in a portable and disposable format.

The University of Birmingham has launched a £5 million investment plan to double the number of commercial spin outs within five years.

Alta Innovations, the university’s commercial arm, will double the number of business managers seeking out new inventions from the institution’s 3,400 academics.

Now, for the first time, the £5 million investment fund will enable the university to partner with venture capitalists to invest into its best inventions.

Alta Innovation’s chief executive James Wilkie said: “Thanks to this new investment, backed by the university, Alta Innovations will be able to invest directly in its spin outs.

“We will be able to provide very early stage investment into the most exciting inventions that are developed by the university’s brilliant academics.

“This new £5 million fund is a direct result of progress by the Alta Innovations that has pushed Birmingham to fifth in the UK for identification of new inventions.

“It allows us to fully realise the potential of inventions that have real potential to benefit society.”

Alta Innovations operates at the Birmingham Research Park, on the university’s Edgbaston campus.

It is backing a number of the institution’s spin out companies including Smart Antenna Technology, which has secured £3.3 million investment to develop a multi-use antenna for laptops and mobile phones.

The firm is also leading the development of a high-tech medical cluster centred around the university and the Queen Elizabeth Hospital in Edgbaston.

Last year, the company opened the BioHub, a £7 million facility that provides affordable laboratory space to medical tech start ups.

Dr Wilkie said: “The BioHub is a fantastic facility for early stage medical start ups. The space is affordable and start ups can receive business advice on marketing and protecting their intellectual property.”

Dr Wilkie said the BioHub Birmingham was more than half full and had plans in the pipeline for future expansion.

http://www.birminghampost.co.uk/business/business-news/university-birmingham-launches-5m-mission-11358883

In the second part of our series, editor Thierry Heles takes a closer look at how Birmingham University is building a complete ecosystem for spinouts, startups and late-stage companies.

full article: http://www.globaluniversityventuring.com/article.php/5222/alta-innovations-the-future-of-success

Birmingham Research Park Tenant Abingdon Health Ltd today announces the signing of a collaboration agreement with Sumitomo Chemical Ltd to develop a next generation multiplexed point of care biosensor device.

This agreement follows a 2 year joint development agreement (“JDA”) between Molecular Vision, a subsidiary of Abingdon Health, and Sumitomo Chemical, to prove the feasibility of the device. The JDA focused on integrating lateral flow devices and printed electronic technologies to produce an easy-to-use compact device for a variety of diagnostic applications.

Chris Yates, CEO of Abingdon Health, said: “After a successful two year collaboration we look forward to continuing to work with our partner Sumitomo Chemical to develop our new biosensor device. With the advent of big data within medical diagnostics coupled with the increasing desire for connected point of care testing we believe that this multiplexed biosensor device will have considerable applicability now and in the future.”

Enquiries:

Dr. Chris Hand, Chairman
Chris Yates, CEO

Tel: +44 1904 406 082

Official press release:

Commercialisation agreement announced to launch new biosensor device

Hands-on Interactive Statistics Training Workshops

From Tracer Measurement Systems Ltd

Given by Dr. John Thompson, C.Chem., F.R.S.C., F.R.Stat.Soc.

In the Institute of Research and Development, Birmingham Research Park,

Vincent Drive, Edgbaston, Birmingham B15 2SQ

May 17th/18th Introductory Statistical Quality and Process Control

May 25th/ 26th Statistical Design and Analysis of Experiments

June 7th Introductory Clinical Statistics

June 8th Statistical Analysis of Reliability Engineering Data

June 21st/22nd Further Statistical Quality and Process Control

June 28th/29th Further Clinical Statistics

July 18th/19th Design & Analysis of Clinical Diagnostics Trials

July 25th/26th Design & Analysis of Clinical Therapeutics Trials

For more information on each workshop and for booking forms, please contact Dr. Thompson at: statisticstraininguk@btinternet  

In part one of a series about Birmingham’s Technology Transfer Offer,  Thierry Heles talks to CEO James Wilkie about Alta Innovations’ origins, ambitions and recently secured first seed fund.
Read More here: http://www.globaluniversityventuring.com/article.php/5207/alta-innovations-the-origins-of-success

With around 14,000 Life Science jobs, the West Midlands has a much stronger track record in this sector than many people realise. Large clusters such as the Edgbaston Medical Quarter have been growing steadily since the 1930’s. This growth isn’t an accident – when the original architect planned and built the old Queen Elizabeth Hospital in 1933 next door to the University of Birmingham Medical School, he said that ‘Modern hospital and medical practice demands there shall be organic and integral connection between the scientist and the clinician for the most efficient treatment of the patient.’

Read more here:http://www.bqlive.co.uk/2016/03/10/life-sciences-and-the-west-midlands

Dr David Bullock

Consultant Clinical Scientist and Director, Birmingham Quality

BIRMINGHAM QUALITY, ESTABLISHED IN 1969 AND THE PREMIER EQA PROVIDER IN CLINICAL CHEMISTRY, IN 1994 CONTINUES TO FLOURISH AFTER 21 YEARS AT BIRMINGHAM RESEARCH PARK. A RECENT HIGHLIGHT IS THE GRANT OF ACCREDITATION TO ISO/IEC 17043:2010 STANDARD FOR PROFICIENCY TESTING.

External Quality Assessment (EQA) services ensure that all hospital laboratories and other testing sites give the correct result wherever specimens are analysed, safeguarding quality, safety and equity of patient care across the UK, as all measurements (including blood tests) are subject to variation. EQA safeguards reliable patient care through assessment and surveillance of the performance both of laboratories and of the commercial products they use. The department provides consultant advice and assistance so they can maintain and improve performance.

The aim of an EQA scheme is to provide clinical laboratories with an objective assessment of their performance, to help them improve the standard of their results and hence the quality of patient care. Scheme operation includes the regular and frequent postal distribution of test materials to participating laboratories for them to analyse. Results are received from the laboratories and, using computer systems, informative reports are prepared for the participants.

The UK National EQAS for Clinical Chemistry was established in 1969 at the Queen Elizabeth Hospital in Birmingham with a £500 grant from the then Ministry of Health. Since then the service has developed, under the aegis of the Department of Health (DH) initially and the UK NEQAS Consortium since the mid-1990s, and currently operates more than 30 programmes with 24 staff and a turnover of £2M. We also provide software and secure web services for 7 other UK NEQAS centres, encompassing all clinical chemistry and microbiology investigations.

Birmingham Quality (BQ) is a self-financing NHS unit, operating on a non-profit basis within University Hospitals Birmingham NHS Foundation Trust. We provide UK NEQAS services, some BQ services for point of care testing, and the International EQAS for Clinical Chemistry as a WHO Collaborating Centre. This activity requires the production and distribution of 325,000 specimens per year for over 3,000 participants in the UK and overseas, with 85,000 reports including around 1.5 million individual test results.

Early growth was accommodated within the Hospital, but continuing expansion led to a move to the Institute of Research & Development at Birmingham Research Park. Our initial 6 units have increased to 12, with remodelling of the premises to fit our workflow. The accommodation is a mixture of office and laboratory facilities for specimen preparation and storage in 35 -40C freezers. This secure base has encouraged the consolidation of other UK NEQAS services, notably UK NEQAS for Steroid Hormones from Cardiff in 1996 and UK NEQAS for Haematinics from Sutton Coldfield in 2015.

The main advantages of Birmingham Research Park for BQ’s growth have been:

• Quality of accommodation – “the first time we weren’t ashamed to have visitors”
• Flexibility – the ability to increase contiguous space as required
• Location – near NHS Blood & Transplant and Queen Elizabeth Medical Centre (Queen Elizabeth Hospital Birmingham and Birmingham Women’s Hospital)
• Facilities – rental of facilities (extraction hood and -80C freezer space) in the BioHub which do not justify investment in dedicated equipment within BQ

The department has pioneered the application of EQA in laboratory medicine, and other expert centres look to BQ for advice on service design and delivery. As our service assesses the performance standard of entire laboratories, quality requirements are high. Our services have been accredited by Clinical Pathology Accreditation (UK) Ltd since the introduction of Standards for EQA services in 1997. We have now achieved accreditation by UKAS against the new International Standard ISO/IEC 17043:2010 for proficiency testing.

BQ services not only underpin clinical governance for UK laboratories and monitor laboratories delivering National Screening Programmes (Newborn Bloodspot Screening, Bowel Cancer Screening) but also have global influence on diagnostics manufacturers (eg Abbott, Roche, Siemens) and contribute to the evidence base for NICE and other national guidelines.

www.birminghamquality.org.uk

One year on from the official opening by the Vice-Chancellor Professor Sir David Eastwood, we have made great progress and achieved more than 50% occupancy of The BioHub ground floor.

There’s an exciting and strong pipeline of start-up companies planning to join the community which is growing amongst the tenants. Abingdon Health, Linear Diagnostics and Analox Instruments will soon be joined by Nonacus Ltd.