Without being dramatic, the prospect of a catastrophic loss of important reference materials is very real and could have unforeseen commercial implications. Loss of reference material would delay launch to market, slow the pace of future developments, impact investment returns, not to mention value to the business.
There’s no doubt Biotech research offers value and contribution to drug development and can deliver simply because they are more agile and responsive than their goliath Pharmaceutical colleagues. But are Biotech companies gambling with investors’ money by missing the opportunity to manage comprehensively the risk to their temperature sensitive stored materials?
Biotech’s research groups are today focused on many aspects of drug development, but none more so than the rise of personalised medicines. These targeted forms of medicines require that the genetic code of many cancers are better understood, stored and held for reference and study.
These frozen libraries of tissue samples must be stored at -180 to preserve genetic material, but should a freezer fail, and temperatures rise, the potential for loss of these valuable reference materials is a genuine nightmare.
This genetic material is in the form of cell lines, human tissue, bio-makers and diagnostic reference materials and are all held and stored in large laboratory-grade fridges, freezers and cryogenic tanks. To say they have no commercial value is naïve, it is the very core of the business. Any due diligence from a potential investor will highlight this risk and need it corrected.
When a biotech company decides to manage research inventory risk to avoid the potential loss, its important to choose a partner with a robust temperature monitoring solution. A temperature sensor coupled to a blue tooth app is unlikely to provide effective cover. In fact, it could lead to a false sense of security.
Tutela have seen that simple text and email systems fail to convey to the member of staff the seriousness or urgency of the situation. Texts and emails can be lost, and if a 3rd party account is not topped up from a credit card, then the service is stopped, removing all cover.
The trained support team call clients from Tutela’s UK office HQ in Fleet, asking for a name seals in the importance and responsibility of the call. Real people notifying clients’ staff, taking their details and opening an incident report, backed up with an email confirming the call.
The difference in urgency is huge, and the member of staff on site becomes 100% clear of what their responsibility is. Tutela’s role as a partner is to remove the burden of administration, while providing piece of mind that often priceless research materials are under constant digital surveillance, and protection.
The Tutela temperature monitoring system also ensures compliance to Biotech’s regulatory requirements are met with an unparalleled audit report trail for inspectors and auditors alike. Incidents are listed, together with actions taken, and that the required corrective action and recommendations were implemented and finally signed off.
By implementing a Tutela temperature monitoring system, customers such as the APHA (Defra) have minimised their risk, protected their material 24/7/365 continuous, uninterrupted monitoring in near real-time of their valuable tissue, pathogen and virus reference materials.
Many of these samples are stored in Cryo, ultra low freezers, -20 freezers, fridges, and working ambient and pressure sensitive laboratories as well as incubators and ovens.
All of these temperature-controlled environments needed careful monitoring to remain compliant at all times and to manage risk. With over 40 years of reference materials, these assets need safeguarding with a proven cost effective system with clear benefits.
Staff at APHA use the Tutela web-based interface. This powerful graphical user interface (GUI) is is provided for an unlimited number of staff and is specifically set up by the site administrators to allow users access to their departments and probes.
Refined built-in administrator options ensure that users are allocated the correct permissions. The web interface allows multiple site viewing for central QA reporting, as well as individual local view for system operators
Tutela was chosen as a trusted partner by APHA (DEFRA) partly because of our ability to support reliably the scale of installation and also because of adherence to calibration standards such full UKAS ISO17025 which allows onsite calibration, further minimising risk to interruption to stored materials.
In addition, Tutela’s quality standards comply with ISO 9001 – 2015, and all electronic records are fully FDA 21 CFR part 11 compliant, securely stored on mirrored servers in two different geographical locations for up to 30 years. All this this provides a highly secure, robust and backed up service.
Tutela understands the importance of reacting quickly and clients will be notified of alarms by our trained operators within minutes of an alarm to a pre-agreed response procedure and contact list, to ensure absolute viability of your valuable inventory.
With clear leadership and independent monitoring of the Biotech and Life science industry, Tutela protect your investors interests and the potential of future investment when clinical trials show positive results.
Together, Tutela aim to partner and reduce the risk, protect reputations and support the Life science industry in its research goals.
Tutela protect your business or organisation from catastrophic loss and damage which cannot be recovered and provide auditable data for future trending and preventable loss, reducing administration and running costs.