FAQs
Cryoniss FAQs are designed to help you find the answer to frequently asked questions. If you have a question not mentioned on this page, please get in contact with a member of our team who will be happy to help you. To learn more about our specific services, please click here.
What are Cryoniss’ accreditations?
Cryoniss Accreditations
Cryoniss are all about quality, and we are highly regulated and have attained a number of exceptionally valued, sought after licences and accreditations. Learn more about how our various credentials can help you and your organisation with your biological sample storage and end-to-end cold chain logistics needs. Our accreditations include the following, MHRA, HTA, HSE and APHA.
Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA supports innovation through scientific research and development. Part of the MHRA’s responsibility is ensuring that the supply chain for medicines, medical devices and blood components is safe and secure. Cryoniss holds a Wholesale Distribution Authority (Human) licence enabling it to store and coordinate the logistics of human Medicinal Products.
Cryoniss is compliant with the following regulations:
- EC guidelines for GDP of Medicinal Products for Human Use.
- Directive 2001/83/EC Community Code relating to Medicinal Products for Human Use.
- Regulations 43-45 of the Human Medicines Regulations 2012.
Human Tissue Act 2004 (HTA).
The Human Tissue Authority (HTA) is the governing body created to regulate activities that come under the HT Act.
At Cryoniss, we are compliant with:
- Human Tissue Authority and the HTA Codes of Practice A & E.
- The Medicines for Human Use (Clinical Trials) Regulations 2004.
- EMA reflection paper for laboratories carrying out clinical analysis.
HSE Level 2 GMOs
The HSE governs the following regulations that Cryoniss is compliant with:
- Genetically Modified Organisms (Contained Use) Regulations 2014 (‘the GMO(CU) Regulations’
- Control of Substances Hazardous to Health Regulations 2002Cryoniss is licenced to store up to and including level 2 GMOs and adherence to these regulations enables Cryoniss to provide storage for a wide range of research tools and reagents.
APHA Category 2
As part of its remit, APHA provides security against animal and plant diseases, alongside other hazards. Animal by-products are defined as any material isolated from an animal (not human). ABPs can present a risk to human and animal health, in particular in relation to:
- Transmissible Spongiform Encephalopathies (TSEs).
- Dioxin contamination.
- Exotic diseases such as Classical Swine Fever and Foot and Mouth Disease. The APHA enforces the following European and UK regulations pertaining to the transport, storage, use and disposal of ABPs.
- Article 23 of regulation (EC) No. 1069/2009 – sites must be registered for use or disposal of Animal by-products (ABP) under 24hr prior notification to DEFRA for ABP importation.
- Animal by-products Enforcement (England) Regulations 2013 (ABPE) -establishments using animal by-products (ABPs) intended for research and diagnostic must be registered by APHA.Cryoniss is licenced to store Category 2 (High Risk) and Category 3 animal material at The Heath and Category 3 material at Alderley Park. Clients’ research samples often contain animal by-products (for example foetal bovine serum) or may even be taken directly from an animal, for example in vivo samples.
This APHA accreditation verifies that Cryoniss has the processes and procedures in place to ensure that these materials are stored in an appropriate manner.
How do I pay for Cryoniss sample storage?
All of our services are tailored on a case by case basis. Every client has access to the same level of services and facilities, however, we find that the most flexible and affordable option is to discuss your requirements with you directly to determine the most suitable payment option. For more information or to discuss your requirements with our team, please contact our team.
What is cell banking?
Cell banking is the process of storing cells in a specially designed facility to maintain the integrity of those samples for long periods of time. The purpose is to maintain the cell sample for the future, which could be used for a product or medicinal needs.
Whilst cryopreservation remains the primary method of choice, long-term cellular viability is dependent upon an optimised freezing, thawing and recovery process. At Cryoniss we use the latest technologies and have optimised our cryo-handling procedures to ensure sample integrity. These procedures include the use of liquid nitrogen adsorbed workstations and dry shippers for shipments between sites.
For more information on cell banking, click here.
What is Cryoniss clinical sample security and accessibility?
Clinical sample data is stored on a secure, HIPAA compliant, fully auditable, cloud-based laboratory inventory management system.
Bespoke, secure customer portals can also be created, providing visibility of your samples.
We provide next-day dispatch and receipt of samples as standard and are very happy to accommodate urgent requests.
Our premium courier partners put sample integrity and customer service at the heart of their offering.
How does the Cryoniss clinical sample storage work?
Cryoniss provides secure storage of clinical samples from Phase 0 through to Phase IV. Clinical samples can be stored at ambient temperatures, +4°C -20°C, -80°C and vapour phase liquid nitrogen (-196°C). In certain circumstances, same-day access is available.
- The Cryoniss pay-on-demand pricing model means upfront costs are limited to a small setup fee. This is to facilitate the reservation of storage capacity.
- Our world-class storage facilities, provide alerting and reporting functionalities which are monitored 24/7 with 21 CFR Part 11, ISO9001 and ISO17025-compliant laboratory systems.
- Complete backup arrangements are in place for all our facilities.
- Cryoniss processes and procedures have been diligently developed to ensure sample integrity is always of the highest standard.
- We operate to the principles of Good Clinical Practice and Good Laboratory Practice.
- Upon completion of the clinical study, we will continue to store samples under our Human Tissue Authority licence.
- Clinical samples can be retained for future research purposes if required.
- We also have appropriate procedures in place for the repatriation or disposal of clinical samples.
For more information about our clinical sample storage, click here.
What are Cryoniss logistics services?
Cryoniss work seamlessly with a range of premium courier partners to provide our clients with complete end-to-end logistics support. The core goald of our logistics service is to provide peace of mind for the quality of your samples at every stage of the transfer, removing the paperwork overheads of coordinating consignments.
Cryoniss specifically work with experienced couriers who are familiar with the medical, biological, pharmacological and biotech sectors. This ensures the needs of our customers are effectively met. For more information on logistics, click here.
What are Cryoniss’ facilities and standards?
Our facilities are monitored 24/7/365 with 21 CFR Part 11 and ISO9001 compliant laboratory monitoring systems, providing alerting and reporting functionalities and all of our procedures are in line with the principles of Good Laboratory Practice.
Enabling our customers to ensure their research always remains of the highest possible standard is the cornerstone of our business.
We work to maintain optimal storage and end-to-end logistics service. We provide our customers with next-day access to their samples with minimal effort.
What kind of samples do Cryoniss store?
Cryoniss bioreagent storage capabilities mean that we are registered to store the following:
- Human Tissue Act-regulated research samples
- Genetically modified organisms, up to and including class II
- High-risk category 2 animal by-products, as regulated by the Animal and Plant Health Agency
Our qualified storage facilities operate from ambient, +4°C, -20°C and -80°C down to vapour phase liquid nitrogen (-196°C).
In what territories does Cryoniss operate?
Cryoniss work with start-ups, universities, research facilities and blue chip clients both from the UK and across the globe. We provide everyone with the same level of ethical and secure storage and transportation of their samples. We are based in the North West of England, however we welcome clients from anywhere in the world. Our world-class storage facilities are located at the Alderley Park bioscience campus near Macclesfield and The Heath Business and Technical Park in Runcorn.
What sectors do Cryoniss services support?
Cryoniss strive to support any area of interest, ensuring the same level of service is provided to university research and biotech startups as is provided to global pharmaceutical enterprises. We support a range of services including blue sky research, pre-clinical research, clinical research and post-market approval. For more details on these services, click here.
What are Cryoniss accreditations?
Cryoniss care about quality. We are highly regulated and have attained a number of exceptionally valued, sought after licences and accreditations. You can learn more about our accrediataions by clicking on the links below. Our credentials can help your organisation with biological sample storage and end-to-end cold chain logistics requirements.
You mention end-to-end cold chain logistics service, can you help with other shipments?
At Cryoniss, we endeavour to remove as much non-value-added time from our customers as possible. Coordinating the logistics of sample shipments, we believe is not the best use of highly skilled scientists’ time. Whether it is hunting around for dry ice and packaging or chasing customs for updates, scientists should be at the bench driving forward scientific advances to make a difference to patients’ lives. It is for this reason, we provide a fully tailored logistics management solution to our customers. As we have the scientific expertise to understand the sample biology, coupled with extensive experience of coordinating international shipments of biological and biohazardous materials, we are able to work on our customers’ behalf to provide an end-to-end solution. Working with our premium couriers and on-site scientists we schedule the delivery of complete validated packaging for the samples to be put in and taken away by the courier. Working with our courier partners, we complete all import and export paperwork and ensure the shipment has been pre-approved by customs before the samples are collected. During the shipment, we provide routine updates to customers and in the event of any issues or delays, we work on our customers behalf to resolve these expediently, whilst guaranteeing the samples remain of the highest quality. For example, dry ice replenishments are standard practice.
Can you help me acquire biological samples?
Our specialism and business focus is ensuring your biological samples are 100% secure and maintained to the highest quality. However, we have extensive experience of sourcing cell line reagents and patient material. Through our specialist network, we are able to provide guidance on who to contact and how to acquire biological samples. Please get in touch with your biological samples acquisition questions.
You mention a one-off customer onboarding fee? What is this for and how much does it cost?
We are highly regulated by multiple governmental organisations. This means that we are required to ensure that all samples and products we store have been legally, ethically and morally acquired and we are allowed to store them on behalf of the customer.
Depending upon the complexity of the samples, their origins and route to our facility, we must complete a due diligence exercise. This requires cross-reference of governmental requirements and ensure our internal tracking and documentation clearly shows that everything is above board.
We undergo annual on-site audits by our accreditors. They check through our Quality Management System for evidence that these due diligence checks are in place. If we find any documentation missing, we will do the leg work on your behalf to get everything in place for you.
The price of the onboarding is very much depending upon the complexity of the samples stored, and where they are coming from. For example, checks on the import and export permits, coupled with APHA and ethical requirements for non-human primate samples from China will take us longer than GMO level 1 bacterial sample from an established UK provider.
What is the pay-as-you-go sample storage contract?
Science is unpredictable and delays to projects happen all the time. This can be through customs delays, project initiation delays, patient recruitment delays and more. For this reason, we implement as standard a pay-as-you-go invoicing process. This means you are charged for the max number of samples you stored with us the previous month, irrelevant of how many you thought were going to arrive with us. Unfortunately, as standard, we are unable to prorata our invoices to the day number (i.e. if they arrived on the 29th of a month it would still count). We do not implement monthly monitoring fees until you deposit your first samples with us, even if the contract is signed.
Is there a minimum sample number to store?
Not at all. We allow our clients to send a single sample vial. However, we do have several regulatory checks that we must routinely complete, therefore we do have a small monthly administration fee applied. For more information on these fees, please get in touch and a team member will get back to you.
We do not require GLP level of storage, do Cryoniss offer multiple levels of service, to keep the costs down?
At Cryoniss, we believe the quality of data generated in any experiment is only as good as the reagents used. Validating reagents in lieu of the actual interesting experiment takes time to do, therefore once you’ve optimised your samples it is important to keep them in the highest condition and standards as possible.
When Sonia & Phil first developed the Cryoniss Quality Management System, they had this philosophy in mind. This entailed that every sample must be treated to the highest standard, and using the principles of Lean Six Sigma.
Cryoniss team developed an internal process and procedure. This aims to ensure the integrity of every sample is maintained to the highest quality. Using this streamlined approach, Cryoniss are able to keep costs competitive, whilst delivering a personalised tailored approach.
For costs and further information, please contact our team.
What alerting facilities do Cryoniss have to notify of any temperature excursions?
All of the Cryoniss storage units are fitted with UKAS validated temperature probes. Should there ever be a temperature excursion, alerting facilities activate and the Cryoniss on-call team receive SMS text messages and emails. This alert system operates 24 hours a day, every day of the year with Cryoniss team members always being available to attend facilities if required.
At what temperatures do Cryoniss store biological samples?
At Cryoniss, we can accommodate storage of biological samples from ambient, +4˚C, -20˚C, -80˚C and -196˚C (vapour phase liquid nitrogen) in our world-class facilities. The purpose of biopreservation is to maintain the integrity of biological samples over time with the ability to recover them on demand in the future for further research.
The temperature at which samples are stored depends greatly on how the samples have been preserved against degradation of the samples and infection from contaminants. Scientists use multiple different methods to protect the samples and depending upon the end-user assay and target molecule determines how these samples are prepared and ultimately stored.
For example, dimethyl sulfoxide used as a cryopreservant for storage of live cell lines to be recovered from -196 ˚C is a different requirement from storage of formalin-fixed paraffin embedded tissues that can be stored at room temperature. However, if the analysis in the future of the FFPE samples is for RNA purposes then it is better to store them at +4 ˚C for long-term.
How much time do I need to give Cryoniss to retrieve a sample from storage?
By storing samples with us at Cryoniss, you entrust us to keep them safe and to the highest level of integrity in our world-class UK based storage facilities.
These samples have ultimately been created to drive forward scientific research. As such, you need access to them expediently, especially when things go wrong.
As standard, our contracts are set up that clients can have access to samples next working day by notifying us by 11am the prior working day.
Cryoniss provide our clients with the direct contact details of your account manager and deputy account manager. If you need your samples urgently (24/7/365), we will immediately arrange this for you same day. This includes shipment of samples domestically. There is a slight surcharge for urgent requests to cover our resource overheads.
All Cryoniss facilities are fed directly by two independent sources of electricity from the local power station. Alongside this, we have our own generator, which will power the facilities automatically in the event of power supply failure.
All our storage units and equipment undergo routine maintenance, including servicing and stress testing. For every 3 live storage unit, we have a single unit always kept free for back up, allowing us to quickly and safely ensure any items stored with us remain at the required temperature should any issues occur.
On top of the electrical back up and storage unit back, Cryoniss also has a full disaster recovery plan.
