Cryoniss Achieve MHRA Approval

Enabling Exceptional Science – More than a tagline as Cryoniss gain MHRA licence.

MHRA SONIA | Cryoniss

Recent MHRA achievement announced.

Last week, we announced our team’s tremendous achievement in attaining the MHRA awarded wholesale distribution authorisation licence, enabling us to roll out our specialist storage and logistics management services to companies and institutions that manufacture drugs for patients, including those supporting the national Covid-19 vaccine effort.

This builds upon our existing accreditations, so that we are now able to support our customers from early-stage blue-sky research, through to pre-clinical, clinical, and now commercialisation of their products – Supporting our customers every step of the way.

In this interview, Cryoniss CEO Sonia Houghton discusses the tremendous achievement in being awarded an MHRA wholesale distribution authorisation licence.

Reflection on achieving MHRA licence

Since gaining our MHRA licence, I have been reflecting back on our company’s journey so far. I am so proud of what our team has achieved, but it is the “why” and “how” we have achieved it, that gives me the most pride.

For those in our readership who do not know me, I started my career as a pharmaceutical research scientist, and with a career spanning 20 years to date I have been fortunate to work across multiple drug discovery and development pipelines, in a range of disciplines and therapeutic areas. I’m always being told off for saying I’m a ‘jack of all trades’, but that is the best way to describe my scientific career.

The only common thread throughout my entire scientific journey has been removing blockers in order to support projects to expedite the life-saving drugs reaching the patients who need them.

We can all relate to real-life experiences when our own health, or that of our loved ones, has been impacted, and can vividly remember the worry and fear that comes with it. What our industry does impacts people’s lives. Therefore, whether it was implementing new technologies to solve a specific mode-of-action query, carrying out a bespoke safety-tox experiment at one o’clock in the morning to support an FDA approval, or working up a patient stratification assay for a clinical trial, if there was an issue, I would try my best to resolve it.

When talking to Phil about establishing Cryoniss, it was this passion for customers and ultimately patient survival and their quality of life which gave us the excitement, and ultimately over the following years, stamina, to make this company a reality.  We knew we could make researchers’ and clinicians’ lives easier by removing blockers for them: we had, after all, been successfully doing it for years within AZ.

Whilst our main customers are other scientific companies and institutions, the scientific research they are pushing forward is revolutionising the scientific and medical world and it is a pleasure to support them and be part of their journey.  If we can in any way remove blockers or non-added value work from their workflow, they will have more time to focus on the important things.

It is always a great feeling to share the success stories of our collaborators in our newsletters, and I would like to take this opportunity thank our contributors for their hard work and time generating these articles for us.

So that is “why” we decided to establish Cryoniss… To enable exceptional science. To us, it is so much more than a tag line!

Delivering on our passion to support our customers

However, equally important is ‘how’ we deliver this passion to support our customers.

Trust me when I say that I can vividly remember the cold sweats and panic resulting from having had my own samples discarded from freezers following a colleague’s exuberant Christmas clean-up, or my own samples stuck and thawed at customs, rushing to site in the dead of night as freezers and facilities are in alarm etc. I have lived and re-lived the terrifying realisation of what has happened, worried about the implications to the timelines of the project and the cost implications of repeating the work (if it is at all possible even) etc.

That is why I appreciate that our job is not just to keep the samples secure but equally to provide our customers with assurance and peace of mind that their irreplaceable samples are safe with us.

To do this, we have to be honest with our customers, particularly if anything goes wrong. It’s then that we must be truly open about what happened, what we have done to fix it, describing any risk placed on their samples and what we have done to ensure it will not happen again. We must have excellent communication and always be consistent.

Obviously, our customers store their precious samples with us as we have world-class facilities, which include the dual monitoring and watch-dog functionality kindly explained by Paul Flood in this month’s newsletter and are covered in an extensive business continuity management system to ensure nothing does go wrong.

The Business Continuity Management System is just a part of our Quality Management System, which comprises 219 policies, procedures, risk assessments, training matrices etc. This Quality Management System took Phil and I two years to develop. With the support of Doug McKechnie from QualiSys, we took our combined 65 years’ experience of working to various standards and built a new QMS that was built on the founding principles of Lean Six Sigma. We developed the controls and procedures to deliver a consistent service, with appropriate checks and balances to ensure compliance with regulatory laws and adherence to our quality objectives. This past year has more than ever highlighted the need for companies to move quickly and having an agile QMS that we could adapt in a controlled manner to tailor our services to our customer’s needs was imperative.

As our backgrounds were drug discovery and development research, we focussed initially in 2018-2019 on gaining accreditation to store pre-clinical to clinical samples, including:

  • HSE license for genetically modified organisms up to and including GMO level II
  • Animal and Plant Health Agency licence to store animal-by products category B
  • Human Tissue Authority for research samples

However, the recent adaptation of our QMS to support the storage and logistics management of medicinal products and the security of the product supply chain demonstrates just how agile our QMS is. These documents, carefully controlled by our Documents Manager, Caroline, are not just a set of documents written for a box ticking exercise, however. They specify exactly how the team works, and it is the precise knowledge of the entire QMS by the team that makes it a success.

At this point, I would just like to say a special thank you to Anna Kocaczek, who began working with the team in November 2020, specifically to support our MHRA application. Anna, has done an incredible job learning our QMS, bringing a fresh pair of eyes and implementing multiple improvements to the systems. Now we have successfully achieved this MHRA accreditation, Anna is continuing to work with us as a member of our Compliance and Ethics Team to ensure we maintain our quality and regulatory standards.

Alongside Anna, Caroline and Phil did a fantastic job supporting the MHRA application, and I am very grateful for everyone’s hard work, including of course the extended wider team for keeping everything ticking by whilst we focussed on the application process.

Whilst this article may seem like a meandering diary entry, it explains the story behind why our team is passionate about our company’s values. Again, these are not a corporate box ticking exercise. If we live our values every day to the best of our ability, we will without doubt support our customers to deliver exceptional science.

Cryoniss’ corporate values

  • We use our expert scientific knowledge to make sure our service is efficient, accurate and secure.
  • We make sure our procedures work, time and time again.
  • We are flexible and swift to respond to requests and to change.
  • We are authentic in our interactions and communicate openly, honestly, and respectfully.
  • We understand the value of the samples and products we store and are proud to be trusted with them.

Next steps following MHRA licence

In my last article, I mentioned the importance of maintaining a supportive, no-blame culture, where employees are empowered to represent Cryoniss and support our customers. However, this is only achievable with the correct management in place, leading by example.

It is for this reason; I am pleased and excited to announce the appointment of Adam Sherlock as Executive Chair of the Board. Not only does Adam bring extensive business and leadership experience, Adam has a clear appreciation of our responsibilities to our customers to maintain the highest level of quality service, but also the importance of maintaining a culture that means we and our employees are proud to work for and represent Cryoniss. Thank you, Adam, for all your support to date and we look forward to working with you in the future!