TrakCel joins forces with Cell and Gene Therapy Catapult

by Amy Schofield 12. September 2017 10:13

The Cell and Gene Therapy Catapult (CGT Catapult) has announced a partnership agreement with UK-headquartered company TrakCel to incorporate its needle-to-needle supply chain management platform into the CGT Catapult’s large-scale cell and gene therapy manufacturing centre.

The 7200m2 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.  

The partnership will allow CGT Catapult collaborators to benefit from an established software solution that is able to track cell therapies across the whole supply chain, integrated within its validated systems at the manufacturing centre and associated cryo-storage and logistics facilities.

The TrakCel technology will also link with Thermo Fisher Scientific’s new Fisher Bioservices CryoHub(SM), which is being built next 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.

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 a world first in life sciences innovation.

Keith Thompson, Chief Executive Officer, Cell and Gene Therapy Catapult, said: “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.”

 

Counterfeit Avastin provokes call for stronger laws

by Admin 29. February 2012 12:30

 The discovery of fake vials of cancer drug Avastin in the US has prompted a call by The Lancet for stronger international laws against counterfeiting.

The counterfeit vials of the Roche drug, distributed in the US medical system, contained various laboratory chemicals but no pharmaceuticals.

The case has revealed a complex supply chain involving wholesalers in the UK, Denmark and Switzerland, with a possible source in Egypt or Turkey.

According to the International Journal of Clinical Practice, such global supply chains have resulted in worldwide sales of counterfeit medications doubling between 2005 and 2010 to $75bn.

The Lancet has called for “a binding, international standard for criminalising the manufacture and distribution” of counterfeit drugs to be launched by the WHO and backed up with stronger regulatory oversight and control.

The MHRA, which is participating in the investigation, commented that the counterfeit vials had “incorrect expiry dates and fake batch numbers”.

The manufacture of the fake Avastin was not sophisticated: several organic chemicals were included, but no active pharmaceutical ingredients.

The opportunity for concealment lay in the existing global supply chain. MHRA has stated that the vials were supplied to the US market via a UK wholesaler, buying from a Danish wholesaler, buying from a Swiss wholesaler.

Beyond that, it has been claimed, there may have been an Egyptian supplier and possibly a Turkish source of the vials.

The case reflects the growing risk of counterfeiting to high-cost injectable drugs as well as to oral medications.

Small wheels, big changes

by Emma 12. October 2011 16:19

 

Nanotechnology holds the key to a new generation of medical devices and diagnostics. Mike Fisher of the Nanotechnology KTN looks at how miniaturisation is changing the face of healthcare.

Over the past decade there has been significant interest in the promise that micro and nanotechnology holds for life sciences.

An estimated 40% of US nanotechnology venture capital is being allocated to life science start-ups – and over 2008 and 2009, according to a study carried out by Lux Research, healthcare and the life sciences saw an increase in investment of 42%, while other areas such as manufacturing and materials saw a decline.

Europe has a number of leading biotechnology companies, as well as world-renowned R&D facilities. Traditionally the emphasis of these companies has been exclusively on biotechnology – but more recently the lines between biotechnology and the electronics industries have become blurred, creating a new and exciting field of new applications and markets using techniques acquired in the semiconductor world.

The electronics industry has been transformed by the strategy that ‘smaller is better’, and using these same techniques and applying them in medical and pharmaceutical contexts has opened exciting new market opportunities. The next level of miniaturisation, into nanoscale dimensions, is a booming area of R&D with significant funding being invested worldwide.

Mobile diagnostics

Using miniaturisation, medical diagnosis equipment can now be used outside of the lab: in doctor’s surgeries, remotely, and even on mobile phones. The applications are endless.

Imagine a world where all you need is your smart phone to detect any disease through blood analysis, without the need for costly and lengthy analysis in the lab. That could be real in five or ten years’ time.

Ten years ago the ‘lab-on-chip’ was a concept without a viable market entry point, but now point-of-care diagnostic systems are starting to show clear benefits in disease detection and cancer therapy.

By using these applications to analyse samples of blood, interstitial fluid, urine and saliva, medics are able to use minimally invasive techniques to obtain quick results that are easily collected, with minimal stress and discomfort to patients.

Using miniaturisation in diagnosis means that the size and cost of equipment can be reduced dramatically. Sensors can be made available at the point of care, in many cases providing a diagnosis while the patient is with the doctor. Providing early diagnosis means that the right treatment can be given early, avoiding complications caused by delays.

Micro and nano diagnostic devices can also provide closed-loop systems that continuously monitor patients and respond immediately to physiological changes. This is particularly important in the intensive care unit, where simple parameters such as oxygen levels can be critical.

In the future, as medical systems become fully integrated with semiconductor technology, we can expect lab-on-chip devices that measure information on disease markers, cell count or DNA-RNA from a very small quantity of blood or other biological fluid sampled by pain-free needles, and ways to receive and transmit real-time information from sensors located inside the human body.

With applications such as point-of-care diagnostics already emerging with huge benefits to patients, there is no doubt that the next generation of healthcare technology will be enabled by the use of miniaturisation.

Taking a simple and effective concept from the semiconductor world has already delivered a dramatic effect on medical diagnostics and is now moving into drug discovery, creating new and exciting applications across a wide variety of markets.

Chain reaction

Getting these applications to market has been hindered by a lack of potential investors and early adopters willing to take a leap of faith. However, there are now a significant number of international companies developing these new application technologies, as they have begun to see the clinical effectiveness offered by nanotechnology and miniaturisation.

The current interest in the use of miniaturisation in the life sciences has been driven by the many advances this new concept promises. Individuals, companies and funding bodies are looking for ways to invest in this newly commercialised technology. To ensure success, nano-companies need to secure support from venture capitalists and other funding bodies, which can be difficult in the current economic climate.

However, despite the advanced developments in miniaturisation in the life sciences, the industry is still relatively new and there are a number of gaps in the supply chain that prohibit products from getting to market in an effective manner. It is crucial with any new technology to ensure that all parts of the supply chain interact and keep each other informed of developments and capabilities.

One of the Nanotechnology KTN’s main remits is to analyse this supply chain, determine where the gaps are and encourage companies to recognise the commercial gains that can be reaped from bridging them.

Connecting members of the supply chain with one another means that academics, research specialists, industrial practitioners and funding sources can meet to discuss ideas and business opportunities, thus ensuring the developments in this application of nanotechnology continue.

Clearly, many of the applications in these new markets are novel and as a result have yet to be fully developed and become economically viable. In the quest to make these technologies and applications available to a wider market, clinical efficacy and value to the healthcare payer are ultimately the deciding factors.

Increasingly, products need to be cost-effective – and the materials used to produce each device represent a significant part of the cost. It can be expected that as the use of miniaturisation in life sciences becomes more widespread, the associated costs will reduce and the applications will expand much more widely.

Given the economic benefits it promises, it is inevitable that the use of miniaturisation in the life sciences will continue to be adopted and supported.

 Mike Fisher, PhD, is Theme Manager – Life Sciences & Healthcare at the Nanotechnology Knowledge Transfer Network (KTN).

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