1. Is the use of my in-house microbial isolates for Quality Control testing a regulatory requirement?
2.What types of organisms can you convert to CryoLC® and CryoHC®?
Cryologics can convert aerobic bacteria, facultatively anaerobic bacteria and fungi to the CryoLC® and CryoHC® formats. We cannot receive and process any organism that exceeds Biosafety Level 2 criteria, as defined by the U.S. Department of Health and Human Services manual, "Biosafety in Microbiological and Biomedical Laboratories".
3. Do you charge any “developmental”, “setup”, “organism” or non-refundable fees? Do you require an advance deposit?
No. Our pricing is straightforward. There are no fees beyond our pricing schedule, and we do not require a deposit. Even shipping costs are included. Click here for our pricing schedule for CryoLC®. Click here for our pricing schedule for CryoHC®.
4. Will I still be charged if you cannot successfully manufacture a CryoLC® or CryoHC® product using my in-house isolate?
No. We’ve experienced nearly 100% success in converting a wide variety of organisms to the CryoLC® and CryoHC® formats, and are therefore confident that we can do the same for you. However, in the event that we cannot achieve success with your in-house isolate, we feel it is more important to inform you as quickly as possible of the outcome and recommend alternatives, rather than charge you for our efforts.
5. How long does it take to manufacture a CryoLC® or CryoHC® product using my in-house isolate?
6. Why doesn’t my CryoLC® or CryoHC® product have an expiration date?
7. How do I submit my organism for manufacture into your CryoLC® and CryoHC® products?
We require a pure culture each time you submit your organism. This may be in the form of an agar plate, agar slant, broth, or other format such as a cryobead. You will need to complete a Sample Submission Form for each organism, and include it with the organism shipment. Please complete as much of the organism information as possible, as this will assist us in more efficiently processing your organism. Kindly ensure that a purchase order number also appears on the form.
8. How do I use my CryoLC® and CryoHC® products?
• Allow vial to completely thaw
• Mix vial by drawing up and dispensing contents 3-4 times (each vial contains not less than 1.0 mL)
• Aliquot suspension
• Use within four (4) hours of thawing
• Do not refreeze
9. Can you manufacture additional products using my originally submitted organism?
No. The manufacturing process concludes with the depletion of all starting and intermediate materials used to manufacture the product. You will need to submit a new organism, even if it's the same organism, in order to have a new product manufactured.
10. Do you confirm the identification of my organism when you receive it?
No. We do not perform identification of received organisms. The primary reason is that, should we perform the identification using a different system or process than yours, this may result in an identification that is different than yours (e.g., same genus, different species). This would not be unexpected, since different identification systems (e.g., phenotypic versus genotypic) are known to occasionally report different results. We confirm the microscopic and/or macroscopic morphology of your organism upon receipt, to ensure that the morphology is consistent with the organism name reported on your Sample Submission Form.
11. What are the required storage conditions for my CryoLC® and CryoHC® products?
CryoLC® and CryoHC® products should be stored at -70°C to -85°C.
12. Can Cryologics ship products outside the U.S.?
No. Cryologics can only receive organisms and ship products domestically within the lower 48 states. However, we have several clients that are international corporations. Many use domestic sites to procure their foreign sites' in-house isolates and send them to us for manufacture. We ship the products back to the domestic sites, which then forward them to their foreign sites.