TrakCel Announces Partnership with Cell and Gene Therapy Catapult to Incorporate Innovative Tracking Solution into Manufacturing Centre Supply Chain

TrakCel solution integration with Cell and Gene Therapy Catapult manufacturing centre enables needle-to-needle supply chain management at any scale

London, UK, September 7, 2017 – TrakCel today announced a partnership agreement to incorporate its needle-to-needle supply chain management platform into the CGT Catapult’s large-scale cell and gene therapy manufacturing centre.  The 7,200m2 manufacturing centre provides a state of the art GMP facility and support infrastructure to enable collaborators to carry out the large scale manufacture of cell and gene therapies as they progress towards commercial supply.

Establishing a robust supply chain from the scheduled collection of patient samples, tracking throughout the manufacturing process and delivery back to that same patient is a complex process. As a result, it is becoming increasingly critical for manufacturers as the patient numbers involved in late stage clinical trials and future commercial supply increase. This partnership will allow CGT Catapult collaborators to plug into an established software solution that will be able to track cell therapies across the whole supply chain, completely integrated within its validated systems at the manufacturing centre and associated cryo-storage and logistics facilities.

“We are pleased to provide our partners at the manufacturing centre with complementary tracking technology, such as the TrakCel Cellular Orchestration Platform, as we work to not only offer GMP manufacturing support in Stevenage but also ease our collaborator’s access to a fully developed, high quality global supply chain,” said Keith Thompson, Chief Executive Officer, Cell and Gene Therapy Catapult.

The TrakCel technology will link, in addition to the manufacturing centre, with Thermo Fisher Scientific’s new Fisher Bioservices CryoHubSM, being built adjacent to the manufacturing centre warehouse. The Cryohub will provide services for distribution of patient sample collection sets, cGMP cryo-storage of cell and gene therapies and also cryo-logistics for supply of these therapies throughout the UK and beyond, with Europe’s busiest airport (Heathrow) just an hour away.

Finally, the TrakCel technology will help further establish the Stevenage Bioscience Catalyst, where these services are located, as an emerging cell and gene therapy cluster not just for the UK but globally by offering another world first in life sciences innovation.

Keith added, “This integration of GMP manufacturing, cryo-storage and logistics support within a complete end to end supply chain management solution is something which has not been done before and is critical to enabling commercial supply of cell and gene therapies in the UK.”

This partnership will provide the world’s first supported GMP manufacturing base for cell and gene therapies enabling visibility across the entire manufacturing and supply process. The TrakCel platform will provide real-time audit logs and chain-of-custody records and will reduce the implementation risks associated with disparate, paper-based systems and therefore accelerate the scale up and scale out of cell therapy processes.  The project will also demonstrate flexibility and the ability to link with any other commercially available or bespoke tracking systems employed by future collaborators in this fast moving field.

CGT Catapult specifically selected TrakCel as it has an established product installed and validated at sponsors, clinical sites, CMOs and logistic partners across North America and Europe.  To minimise risks to product quality and patient safety it is essential that the supply chain is tracked and controlled both before and after the manufacturing process.  The TrakCel platform has been proven to deliver this.

“The cell therapy sector is now starting to move from considerations around clinical development to commercialisation, and multi-layered supply chains involving many more patients, individuals and organisations. Patients will rely on the sector to ensure supply chains involve the adequate transportation of valuable cellular material in the right conditions,” said Ravi Nalliah, CEO, TrakCel. “As the most-advanced software developer for global cell and gene therapy supply chain tracking and orchestration, TrakCel is contributing its tracking capabilities to a range of international collaborations and firms. This partnership between CGT Catapult, TrakCel and Fisher BioServices will deliver the most technologically advanced and secure large-scale GMP manufacturing base for cell and gene therapies in the world.”

About the Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 120 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and
provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK.

For more information please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.

About TrakCel

TrakCel is the market leading designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. TrakCel’s software platform has been developed in collaboration with, and increasingly adopted by leading companies in the cell, gene and immunotherapy industries. TrakCel’s solutions deliver real-time control over the entire therapeutic supply chain, from sample collection through manufacturing to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability.

TrakCel is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey. It aims to employ over 100 people by end of 2019, following a number of senior appointments in 2016 and 2017.

For further information please contact:

Image Box PR

Neil Hunter +44 (0) 20 8943 4685 neil@imageboxpr.co.uk

Michelle Boxall +44 (0) 20 8943 4685 michelle@imageboxpr.co.uk

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SAVSU and TrakCel announce collaboration to integrate Cell Therapy Manufacturing and Cold- Chain data management platforms

Integrating Cell Orchestration and Live Cell Visibility Platforms Will Provide Enhanced, Auditable Vein-to-Vein Documentation Supporting Clinical Trials, Commercial Distribution and Reimbursement of Cell-Based Therapies

ALBUQUERQUE, NM and CARDIFF, UK — April 25, 2017 — SAVSU Technologies, the leading developer of smart precision shipping containers and cloud-based cold chain management SaaS solutions, today announced that that it will collaborate with Cardiff-based TrakCel Ltd to integrate  its evo® Cold Chain 2.0™system with TrakCel’s Cellular Orchestration Platform™.

evo Cold Chain 2.0 is a disruptive live cell visibility platform for management of time and temperature sensitive biologic materials powered by the evo cloud-connected Smart Shipper and evo Cold Chain Management SaaS. This cloud-based, cold chain management platform integrates shipping container pack-out, freight carrier selection and purchase, and real-time GPS location and payload temperature monitoring, with critical alerts provided to stakeholders in the clinical delivery chain, including shipment, approaching destination, delivered, opened and remaining shelf life.

TrakCel’s Cellular Orchestration platform facilitates efficiency and compliance to quality standards in cell therapy manufacturing by enabling program-critical information to be collated, tracked and and documented. Detailed processes and managed workflows for every participant in the value chain enable safe and efficient scaling outward and upward as production increases. Conditional logic workflows for all participants including clinicians, logistics and manufacturing partners ensure standardization and compliance with validated procedures.

Bruce McCormick, President of SAVSU Technologies, remarked, “Our optimized technologies represent the next generation of integrated, cloud-connected cold chain technologies. We are very pleased to collaborate with TrakCel and look forward to integrating our respective data platforms to provide even more value to our mutual customers. We are committed to driving a paradigm shift away from traditional, risk-laden cold chain practices based on the use of poor performing shipping containers and disconnected data systems.”

Ravi Nalliah, CEO at TrakCel, commented, “We scoped the packaging and cold chain technologies space to identify best of breed ecosystem partners. SAVSU is so far ahead of traditional container and data logger suppliers, and we are very keen to integrate their innovations into our Cell Orchestration Platform. The timing of this collaboration is perfect as the cell therapy market continues to mature and awareness is peaked on the need to use better
tools to enable clinical trial success, commercial scale-out, and reimbursement supported by evidence of compliance throughout manufacturing, distribution and patient administration.”

Chain Link Research and Pharmaceutical Commerce market research estimate that there are 80 million to 130 million annual temperature sensitive pharmaceutical shipments requiring cold chain management, resulting in $12 billion spent annually on cold chain logistics, with $9 billion for transportation and $3 billion for specialized tertiary packaging and instrumentation such as insulated boxes, blankets, phase change materials, temperature sensors and dataloggers. The use of currently available cold technologies results in $15 billion to $35 billion spent annually replacing products lost due to temperature excursions.

About SAVSU Technologies
SAVSU is a leading designer and manufacturer of innovative, high performance, cloud-connected passive storage and transport containers for temperature-sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials.

For more information please visit www.savsu.com.

About TrakCel
TrakCel’s cell, gene and immunotherapy management solution improves clinical study efficacy and accelerates global scale-up and scale-out by implementing communications technology to integrate the delivery path from needle-to-needle. The technology provides interactive instructions to
professionals across the supply chain and gives stakeholders on-demand visibility of procedural results and chain-of-custody data for immediate traceability, validation and compliance audits.

TrakCel technology is increasingly being adopted by leaders in the cell, gene and immunotherapy industry. TrakCel is headquartered in Cardiff, Wales with a U.S. offices in Newport Beach, California  and Bridgewater, NJ.

For more information please visit www.trakcel.com.

SAVSU Media & Investor Relations
Dana Barnard
Chief Executive Officer
SAVSU Technologies, Inc.
505.466.1962
info@SAVSU.com

TrakCel Media & Investor Relations
Hannah James
Marketing manager
TrakCel Ltd.
pr@trackcel.com

TrakCel announces the appointment of industry experts Martin Lamb and Robert Margolin

Industry experts strengthen the TrakCel’s industry leadership position.

CARDIFF, WALES, UK – 2 March 2017. Today, TrakCel announced that it has appointed Martin Lamb as Executive Vice President of Sales and Marketing and Robert Margolin as Vice President of Corporate Development and Strategy, further strengthening the company’s position as the leading provider of needle-to-needle cell orchestration technology to aid in the delivery of regenerative therapies.

Having held a variety of senior business development roles in leading contract development and manufacturing organisations throughout his 25-year career in the pharmaceutical and biotechnology industry, Martin brings extensive market insight and industry knowledge to TrakCel. Prior to joining the company, Martin was Director of European Business Development for Catalent Pharma Services – one of the world’s largest contract development and manufacturing organisations. During his time as Vice President of Global Business Development at the Almac Group, Martin helped the group’s clinical trial supply business grow from a niche service offering to a major business with over 1,500 staff internationally. The skills and experience Martin brings to the team will be invaluable to the success of TrakCel moving forwards.

With over 12 years of experience working in the advanced therapy and regenerative medicine sectors of the biotechnology industry, Robert brings a wealth of expertise and experience to the TrakCel team. Before joining TrakCel, Robert was Vice President of Corporate Development for Cognate BioServices, where his efforts enabled the company to evolve into one of the leading commercial-scale cell therapy contract manufacturing organisations. Robert has also previously held positions of Senior Consultant and Vice President of Communications for the Alliance for Regenerative Medicine, and has been responsible for organising the World Stem Cell Summits. Robert’s deep understanding of the industry and cell therapy manufacturing will help to ensure TrakCel continues to be positioned as an industry leader.

“We are delighted to welcome Martin Lamb and Robert Margolin to the TrakCel team,” said Ravi Nalliah, Chief Executive Officer. “The extensive industry knowledge and years of experience Robert and Martin have perfectly extends that of the company. This is an exciting time for TrakCel and we are looking forward to seeing what the future brings.”

About TrakCel
TrakCel’s software platform provides cell and gene therapy companies with a proven solution that delivers real-time control over the entire supply chain, including manufacturing, from sample collection through to treatment delivery. The TrakCel platform accelerates global scale-up and scale-out of cell and gene therapy products by improving efficiency and removing complexity while maintaining compliance and traceability from needle-to-needle.

TrakCel’s technology is increasingly being adopted by leaders in the cell and gene therapy industry. TrakCel is headquartered in Cardiff, Wales with a US office in Newport Beach, California.

Head Office
TrakCel Ltd.
11 Raleigh Walk
Brigantine Place
Cardiff,
CF10 4LN
United Kingdom

www.trakcel.com

Public Relations contact: pr@trakcel.com

US private equity firm invests in leading Cellular Orchestration Platform developer, TrakCel

Investment supports international growth and expansion

CARDIFF, WALES, UK – 17th October 2016.  TrakCel, the leading provider of cellular orchestration technology to aid in the delivery of regenerative therapies, has successfully completed a multi-million dollar investment by San Francisco-based Telegraph Hill Partners to support the company’s global growth activities.

The successful completion of the transaction, following a series of significant new contract wins in the USA and the opening of TrakCel’s US office in Newport Beach California, allows the company to further enhance its technology platform and catalyse its ambitious global growth plans.

“We believe we have found the perfect strategic partners in Telegraph Hill Partners. We are very enthusiastic about the expertise and experience that they bring,” said Ravi Nalliah, CEO of TrakCel. “The team, together with the financial support provided by this transaction, will allow TrakCel to accelerate the development of our full suite of cellular orchestration delivery technologies. TrakCel’s Cellular Orchestration Platform (COP), allied to our growing partner ecosystem, will provide our customers a powerful delivery platform to enable commercialization of both current and next generation personalized therapies and novel treatments for many diseases.”

“THP’s growth investment in TrakCel is the result of our global search to identify and invest in companies positioned to become the leaders providing the infrastructure required to support commercially successful cell and gene therapies,” said Matt Mackowski, Chairman of THP.  “Bringing decades of expertise in pharmaceutical supply chain and information technologies, TrakCel’s team is in the process of scaling up the most advanced cell therapy management system in the field.”

Concurrent with the financing, Matt Mackowski, Tom Raffin M.D., and Rob Hart, CFA from Telegraph Hill Partners, will join the company’s Board.

About TrakCel
TrakCel’s cell, gene and immunotherapy management solution improves clinical study efficacy and accelerates global scale-up and scale-out by implementing communications technology to integrate the delivery path from needle-to-needle. The technology provides interactive instructions to professionals across the supply chain and gives stakeholders on-demand visibility of procedural results and chain-of-custody data for immediate traceability, validation and compliance audits.

TrakCel technology is increasingly being adopted by leaders in the cell, gene and immunotherapy industry. TrakCel is headquartered in Cardiff, Wales with a US office in Newport Beach, California.

Head Office

TrakCel Ltd.
11 Raleigh Walk
Brigantine Place
Cardiff,
CF10 4LN
United Kingdom

www.trakcel.com

Public Relations contact: pr@trakcel.com

About Telegraph Hill Partners

Telegraph Hill Partners manages private equity growth funds dedicated to building advanced technology businesses in life sciences, medical technology and healthcare.  THP manages over $600M and is based in San Francisco and La Jolla, CA.

For more information, visit www.thpartners.net

TrakCel appoints new group CEO

Cell therapy leader TrakCel appoints new group CEO

Company expands leadership team in line with continued growth CARDIFF, WALES, UK – July 5th 2016.

TrakCel, a leading provider of traceability technology to aid in the delivery of regenerative therapies, today announced that it has appointed a new group Chief Executive Officer. Mr. Ravi Nalliah joins the company from PCI Services Inc. a US-headquartered global leader for drug development services and a trusted partner to the world’s largest and most successful pharmaceutical firms. He replaces Keren Winmill, who has stepped back to focus exclusively on her role as Chairman of the Board. “Ravi has excellent business acumen, excels at strategy definition and execution and has a thorough knowledge of TrakCel’s business. He is a respected and capable leader with the drive, ability and energy to adapt quickly to market changes in close collaboration with the Board, the executive team and our employees.” said Winmill. Nalliah was a key member of the team that, in 2009, led the management buy-out of Biotec Services International (Biotec), a leading UK based clinical trials services and supply group specialising in clinical trial services for Phase I to IV trials. He was Chief Finance and Strategy officer of the business and its subsidiaries before leading the sale of the business to PCI Services Inc. in 2014. During his tenure at Biotec, Nalliah identified the need for a digital solution to manage the complexities of the then emergent cell therapy market and led a board-level initiative to establish the TrakCel business unit and provide start-up financing. “I am excited about the opportunity to lead TrakCel into the next phase of its strategic development.

Ravi Nalliah - TrakCel CEO

Ravi Nalliah – TrakCel CEO

The fast-paced changes of cell therapy demand that we adapt quickly and efficiently. Moving ahead our set-up must continue to effectively respond to these challenges while retaining a laser-sharp focus on our customers’ needs.” Nalliah said. Mr. Nalliah is a qualified Chartered Accountant and also holds a Bachelor of Science (BSc), Biochemistry and Molecular Biology. The announcement is part of a series of strategic developments within the business as it builds upon its Clinical and commercial success across the globe. About TrakCel TrakCel’s digital platform manages traceability, chain of identity and chain of custody for complex cell therapy programs. The technology gives stakeholders on-demand visibility of procedural results for immediate traceability, validation and compliance audits. TrakCel technology has been adopted by leading companies in the cell therapy industry. TrakCel is headquartered in Cardiff, Wales. 11 Raleigh Walk, Brigantine Place Cardiff, UK, CF10 4LN

Public Relations – publicrelations@trakcel.com +44 (0)2920 483729

World Courier Joins TrakCel Partner Program

Program unites industry in drive for Clinical supply chain excellence

CARDIFF, WALES, UK March 1, 2016 – TrakCel Ltd., a pioneer in cell therapy process management and supply chain integration today announces World Courier, an AmerisourceBergen company, as a new member of its Connected Services programme.

The Connected Services programme integrates world-leading organizations that are essential to the cell therapy supply chain into the TrakCel platform to provide a “single pane of glass” vision. Participating companies benefit by making their core services and capabilities in Cell, Gene and Immunotherapy more visible and by extending business reach into the industry.

World Courier provides logistics services to healthcare organizations around the globe via 2,000 associates operating in 50 countries. Using a partnership approach, the company provides specialist logistics services that include consulting, transportation management, GxP-compliant transport, inventory management and in-transit time and temperature monitoring. ”The Connected Services programme enables cell therapy companies to readily link to World Courier and the full suite of logistics services we offer.” said Sam Herbert, Chief Operating Officer, World Courier. “By incorporating links into the TrakCel solution we’ll provide on-tap access to cell therapy companies as they move through clinical trials to scaled production.” TrakCel’s technology integrates and automates the entire cell therapy process while providing realtime audit logs and chain-of-custody records to stakeholders.

It reduces the implementation risks associated with disparate, paper-based systems and accelerates scale up and scale out of cell therapy processes through immediate access to data for validation and regulatory audits. “World Courier is an integrated full service provider and a trusted partner to leading companies in the global healthcare industry who share our vision of pursuing cell, gene and immunotherapy supply chain excellence“ said Jon Curley, Chief Technology Officer and spokesperson for the Connected Services programme. “We’re very excited to have World Courier join our other high-calibre organizations working together in the Connected Services programme.” The Connected Services programme accelerates cell therapy success by enhancing TrakCel’s cell therapy supply chain management platform with links to participant firms that specialize in logistics, cell therapy manufacturing, patient treatment, storage, compliance and other essential tasks in the supply chain. For more information on the TrakCel ‘Connected Services’ programme click on the following link. http://trakcel.com/partner-ecosystem.html

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TrakCel About TrakCel TrakCel’s cell, gene and immunotherapy management solution improves clinical study efficacy and accelerates product scale-up/scale-out by implementing communications technology to integrate the supply chain from end-to-end. The technology provides interactive instructions to professionals across the supply chain and gives stakeholders on-demand visibility of procedural results and chainof-custody data for immediate traceability, validation and compliance audits. TrakCel technology has been adopted by GlaxoSmithKline and other leaders in the cell therapy industry. TrakCel is headquartered in Cardiff, Wales, UK. TrakCel Ltd. 11 Raleigh Walk Brigantine Place Cardiff, UK, CF10 4LN www.trakcel.com About World Courier World Courier is a global specialty logistics company that designs world-class supply chain programs in complete alignment with customers’ business goals. The company delivers ultimate peace of mind for the transport and storage of time- and temperature-sensitive products. For more than 45 years, only World Courier has delivered the unsurpassed knowledge, global reach and flawless supply chain execution needed to become the most trusted specialty logistics company in the world. For more information, visit worldcourier.com.

TrakCel selected for EU CAR-T Project

€6 million EU project CARAT to optimise CAR-T development

Cardiff, UK, February 11, 2016 – TrakCel Ltd., a leading provider of Clinical supply chain orchestration technology for cell, gene and immunotherapies, today announces its selection as a key partner in CARAT, an EU-funded project to support the development of CAR T cell therapies. The CARAT (Chimeric Antigen Receptors (CARs) for Advanced Therapies) project aims to integrate innovative cell manufacturing tools and enabling technologies into a single new platform that will facilitate the safe, automated and cost-efficient manufacture of highly effective CAR T-cells. TrakCel Ltd. joins a consortium of leading biotechnology pioneers including:

  • Miltenyi Biotec Gmbh
  • Institut national de la santé et de la recherche médicale
  • Institut (Federal Institute for Vaccines and Biomedicines)
  • European Research and Project Office and Universitätsklinikum Freiburg
  • Ospedale San Raffaele
  • University College London

CARAT will contribute to enabling the development, delivery and commercialisation of CAR T-cell technologies serving patients with so far incurable hematologic malignancies and solid tumours like colon, pancreas or lung cancer. CARAT will enable clinical investigators and companies to focus on treatments rather than hurdles and thus be instrumental for the implementation of improved and more accessible treatment options that harnesses the strengths of the immune system. TrakCel will work towards simplifying the management and manufacture CAR-T therapies by examining supply chain challenges in detail to produce exemplar methods of managing CAR-T supply chains. Detailed scrutiny will be applied to different delivery and management models including local and centralised manufacturing strategies. Furthermore, an application programming interface will be developed to provide a seamless exchange of data between TrakCel’s technology platform and Miltenyi’s cell therapy manufacturing equipment which will simplify needle to needle management, tracking and documenting of cell therapy products. Dr Matthew Lakelin, TrakCel’s Vice President of Scientific Affairs, said: “Participating in this European project will give TrakCel access to some of Europe’s leading cell therapy developers and allow the company to integrate with cell therapy processing equipment.

“This is a fantastic opportunity for the company to be at the forefront of innovation in technology for cellular therapies.”

All available clinical data on CAR T-cell therapy, in particular the efficacy and long-lasting effect suggest this approach will have a clear and profound effect upon quality of life of cancer patients and a high acceptance of the therapy among patients can be expected. The first milestone will have TrakCel execute a supply chain risk assessment that details the risks and mitigation strategies for an exemplar CAR-T therapy. – ENDS – TrakCel publicrelations@trakcel.com About TrakCel TrakCel’s cell therapy process management solution improves clinical study efficacy and accelerates product scale-up/scale-out by implementing communications technology to integrate the supply chain from end-to-end. The technology provides interactive instructions to professionals within the cell therapy supply chain and gives stakeholders on-demand visibility of procedural results and chainof-custody data for immediate traceability, validation and compliance audits. Founded in 2012, TrakCel technology has been adopted by GlaxoSmithKline and other leaders in the cell therapy industry.

TrakCel is based in Cardiff, Wales, UK. TrakCel Ltd. 11 Raleigh Walk Brigantine Place Cardiff, UK, CF10 4LN www.trakcel.com About CAR T-Cell therapy Cancer is highlighted by the WHO as one of the leading causes of mortality and morbidity with more than 50,000 people losing their lives to leukaemia every year in Europe. Chimeric antigen receptors (CARs) are specifically tailored surface receptors that can be introduced into cells of the immune system, especially T-cells, by genetic engineering. They act as recognition molecules like antibodies or T-cell receptors and allow honing of immune responses towards selected targets. T-cells are essential for the human immune system as they scan the human body to eliminate infections and abnormalities. In this respect, CARs are increasingly used for cellular therapy to redirect T-cells specifically towards killing of cancer cells. Recent success stories of cancer therapies based on CAR T-Cells have raised scientific and public expectations to cure severely ill patients. In latest studies T-cell treatments have proven to be very successful; for example, in a clinical trial of a highly aggressive form of acute lymphoblastic leukaemia at the University of Pennsylvania, 89% of children and adults showed no evidence of cancer after receiving a CAR T-cell therapy (Grupp et al., 2013). Consequently, the Food and Drug Administration (FDA) designated T-cell treatment in 2014 as a “breakthrough therapy” for relapsed and treatmentresistant acute lymphoblastic leukaemia in adults and children. However, translation into clinics and broad application of such advanced personalized cell therapy is currently hampered by the technologically complex, costly and error-prone procedure of manufacturing gene-modified T-Cells for each patient individually.

TrakCel appoints new Chief Operating Officer

CARDIFF, WALES, UK January 25, 2016

TrakCel today announced the appointment of James Rudolf to the position of executive vice president and chief operating officer. James previously served as COO with Mood International and, prior to that, as Group MD with Target Group. He brings to TrakCel over twenty years of successful experience in operations, sales and strategy across a range of technology domain.

James Rudolf – TrakCel Chief Operations Officer

 

James will be directing TrakCel’s operational growth strategies and global action-implementation, focused on continual improvement of services and support for TrakCel’s growing list of cell and gene therapy customers.

Cognate BioServices, TrakCel Strengthen the Cell Therapy Supply Chain

 CARDIFF, WALES, UK November 11, 2015 – TrakCel Ltd., a pioneer in cell therapy process management and supply chain integration technology today introduces Cognate BioServices as the newest member of the Connected Service programme.

The Connected Services partner services ecosystem accelerates cell therapy success by enhancing TrakCel’s cell therapy supply chain management platform with links to participant firms specializing in logistics, cell therapy manufacturing, patient treatment, storage, compliance and other essential tasks in the supply chain. Cognate Bioservices is a fully-integrated contract bioservices organization providing the highest level of scientific and management expertise, as well as full development and cGMP manufacturing services to companies and institutions engaged in the development of cell-based products.

”The TrakCel solution empowers cell therapy development companies to integrate and manage the supply chain from end-to-end” said Robert Margolin, Vice President, Corporate Development, Cognate BioServices.

“By partnering with TrakCel in the Connected Services programme we’ll be better positioned to manage the logistical hurdles associated with scale-up of today’s leading autologous cell therapy products from early clinical development through to full commercialization.”

TrakCel’s technology integrates and provides additional control and visibility into the entire cell therapy process while providing real-time audit logs and chain-of-custody records of critical and often irreplaceable components to stakeholders. It reduces the implementation risks associated with disparate, paper-based systems and accelerates scale up and scale out of cell therapy processes through immediate access to data for validation and regulatory audits. “Cognate BioServices provides world-class manufacturing and development services to regenerative medicine and advanced cell therapy companies, organizations and institutions.” said Kevin Smith, EVP Corporate Development, TrakCel.

“Their participation in the programme directly benefits cell therapy companies striving for excellence in supply chain performance.”

‘Connected Services’ provides a “single pane of glass” vision giving real-time visibility of the entire cell therapy supply chain through one platform which is technically and operationally associated with world-leading contributing organizations. Participating companies benefit by making their core capabilities in the autologous supply chain more visible and by extending business reach into the industry. For more information on the TrakCel ‘Connected Services’ programme click on the following link. http://trakcel.com/partner-ecosystem.html

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TrakCel About TrakCel TrakCel’s cell therapy process management solution improves clinical study efficacy and accelerates product scale-up/scale-out by implementing communications technology to integrate the supply chain from end-to-end. The technology provides interactive instructions to professionals within the cell therapy supply chain and gives stakeholders on-demand visibility of procedural results and chain-of-custody data for immediate traceability, validation and compliance audits. Founded in 2012, TrakCel technology has been adopted by GlaxoSmithKline and other leaders in the cell therapy industry. TrakCel is based in Cardiff, Wales, UK. TrakCel Ltd. 11 Raleigh Walk Brigantine Place Cardiff, UK, CF10 4LN www.trakcel.com Iain Wood, Public Relations +44 (0)2920 483729 iain.wood@trakcel.com About Cognate BioServices Cognate is a dynamic, results-driven, contract manufacturing organization focused on providing the broadest range of commercialization services to regenerative medicine and advance cell therapy companies, organizations and institutions. Cognate provides specialized custom manufacturing and development services to companies across all points of clinical and commercial development ranging from early preclinical studies, to mid phase trials and product scaleup though later stage clinical trials and commercial manufacturing . Cognate applies the know-how and expertise of its business, scientific and technical teams to successfully develop biotechnology products across multiple cell-based technology platforms from start to finish. The combination of highly experienced staff, successful track records and cGMP facilities makes Cognate one of the most qualified contract manufacturers of cell-based products in the world today. For more information please visit www.cognatebioservices.com. Cognate BioServices, Inc. Robert E. Margolin, 443-784-2422 rmargolin@cognatebioservices.com

Cell Therapy Catapult and TrakCel to Collaborate on Research Project

Cell Therapy Catapult and TrakCel to Collaborate on Research Project Cell Therapy Process Management solution to be analysed in a GMP-compliant environment January 19, 2015

CARDIFF, WALES, UK January 19 2015 – The Cell Therapy Catapult, which is focused on the development of the UK cell therapy industry to increase the nation’s health and wealth, and TrakCel, a provider of supply chain integration management technology for cell therapies, today announced a research collaboration agreement to explore the utility of TrakCel’s technology in mission-critical situations.

To test Trakcel’s solution in a GMP-compliant environment, over the next three years each company will provide resources, facilities and personnel to form a project team. Beginning in early 2015, the Cell Therapy Catapult will provide advisory feedback and product enhancement input throughout the duration of the project for the benefit of TrakCel’s solution development in cell therapy planning, manufacturing, regulatory and clinical affairs. TrakCel technology improves cell therapy process success by proactively instructing professionals within the supply chain whilst providing real-time visibility to stakeholders. As well as reducing the implementation risks associated with disparate, paper-based systems, the information collected by TrakCel technology enables greater insight into clinical trial data and provides a foundation for regulatory audits. Keith Thompson, CEO of the Cell Therapy Catapult said: “TrakCel is striving to improve the success of cell therapy processes by introducing an innovative approach to cell tracking and control technology that overcomes limitations of the existing industry methodology. Through providing access to our experts and facilities, we’re looking forward to jointly exploring its potential.” TrakCel will install a system at the Cell Therapy Catapult for the purpose of stress testing and analysis in a series of mission-critical situations including inbound/outbound logistics. The project will command a full cell process mapping exercise as well as training for Catapult analysts and experts.

“The Cell Therapy Catapult is committed to fostering innovation and growth in the cell therapy industry.” said Kevin Smith, Director, TrakCel.

“We’re excited to undertake this collaborative research project that will provide vital input to our development team and ultimately accelerate the advancement of our technology.”

The Cell Therapy Catapult will publish its initial findings as to the applicability of the TrakCel solution in the autumn of 2015. TrakCel TrakCel is exhibiting its cell therapy supply chain management technology at the Phacilitate Cell & Gene Therapy Forum, January 26-28, Washington, D.C.. – ENDS – TrakCel Iain Wood, Public Relations +44 (0)2920 483729 iain.wood@trakcel.com publicrelations@trakcel.com Cell Therapy Catapult David Robertson, Head of Communications +44 (0) 203 728 9675 david.robertson@ct.catapult.org.uk comms@ct.catapult.org.uk @CTCatapult Notes to Editors About TrakCel TrakCel’s patented technology is a single solution for controlling cell therapy processes from start to finish, to help assure patient safety, enable efficient clinical study and supply chain scale-up, provide multi-site standardisation and help drive clinical adoption. The technology provides instructions to professionals in the cell therapy process, and gives stakeholders visibility of all activities in the advanced therapy medicinal products (ATMP) supply chain from patient registration and collection of cells, through logistics, storage, processing of the cells in manufacturing and return delivery to the patient. Founded in 2012, TrakCel technology has been adopted by GlaxoSmithKline. TrakCel is based in Cardiff, Wales, UK. TrakCel Ltd. 11 Raleigh Walk Brigantine Place Cardiff, UK, CF10 4LN www.trakcel.com TrakCel About the Cell Therapy Catapult The Cell Therapy Catapult is a centre of translational excellence for cell therapy and regenerative medicine. Its vision is for the UK to be a global leader in the development, delivery and commercialisation of cell therapy, making it a location for business start-up and growth.

Based in London at Guy’s Hospital, the centre takes products into early clinical trials, providing clinical, technical, manufacturing, regulatory, health economics and market access expertise. There is a focus on collaboration and lowering barriers to investment and funding, and operations have grown rapidly since inception. UK Trade & Investment has valued the global regenerative medicine industry at just over £500 million, and estimates that it will be generating revenues of over £5 billion by 2021. For more information go to ct.catapult.org.uk About Catapults Catapult centres are being established and overseen by Innovate UK as a new addition to its range of programmes to stimulate innovation. They are places where the best of the UK’s innovative businesses and researchers work together to bring new products and services more quickly to commercialisation. Focusing on areas with great market potential, Catapults will open up global opportunities for the UK and generate economic growth for the future. For more information, please visit www.catapult.org.uk About Innovate UK Innovate UK is the new name for the Technology Strategy Board – the UK’s innovation agency. Taking a new idea to market is a challenge. Innovate UK funds, supports and connects innovative businesses through a unique mix of people and programmes to accelerate sustainable economic growth. For further information visit www.innovateuk.org