Question 1

1. Is the use of my in-house microbial isolates for Quality Control testing a regulatory requirement?

Accepted Answer

Regulations and compendia themselves do not specify a requirement to use in-house isolates. However, it has increasingly become a regulatory requirement. Click here for a list of regulatory, compendial and industry references on the subject.

Question 2

2.What types of organisms can you convert to CryoLC® and CryoHC®?

Accepted Answer

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".

Question 3

3. Do you charge any “developmental”, “setup”, “organism” or non-refundable fees? Do you require an advance deposit?"

Accepted Answer

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®.

Question 4

4. Will I still be charged if you cannot successfully manufacture a CryoLC® or CryoHC® product using my in-house isolate?

Accepted Answer

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.

Question 5

5. How long does it take to manufacture a CryoLC® or CryoHC® product using my in-house isolate?

Accepted Answer

A CryoLC® or CryoHC® product manufactured from a non-fastidious aerobic bacterium, which represents the vast majority of organisms we process, typically requires less than four weeks. Slow-growers (e.g., filamentous fungi) may require more time. The typical four-week lead time is ideal for certain GMP activities. For example, if implementation of an in-house isolate into your media growth promotion program is identified as a corrective action during investigation of a non-conformance, this action can be implemented before the 30-day due date for completion of the investigation.   Be sure to review our average delivery lead time for CryoLC® or CryoHC®.  From 2015 to 2020, we succeeded in delivering products to our clients in 16-18 days on average!

Question 6

6. Why doesn’t my CryoLC® or CryoHC® product have an expiration date?

Accepted Answer

Although we have a robust manufacturing process, we have no prior experience with your particular in-house isolate. We recommend a “retest date” of six months from the date of manufacture, reflected on your Certificate of Analysis, which is based upon our experience with a wide variety of wild-type organisms. Importantly, we monitor the concentration of your product throughout this six-month period up to the retest date. Although extremely rare, in the event of an observed adverse trend in concentration, we will immediately notify you to discuss options. There is no charge for this testing.   Each of your products is unique, because of the nature of your specific wild-type organisms. As with all GMP materials, expiration dates must be based upon stability data.  Cryologics would not be able to support our unrivaled turnaround times for CryoLC® or CryoHC® if we were required to generate stability data in order to assign an expiration date.  If you use one of our competitors who assigns, for example, a one-year expiration date, after taking three-to-six months to process your organism, you should question what stability data supports their one-year expiration.

Question 7

7. How do I submit my organism for manufacture into your CryoLC® and CryoHC® products?

Accepted Answer

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.

Question 8

8. How do I use my CryoLC® and CryoHC® products?

Accepted Answer

Using your CryoLC® and CryoHC® products is extremely easy.  Simply thaw, mix and aliquot.  They don't require rehydration or the use of more than one component.  The following instructions are included on each product lot's Certificate of Analysis:   • Store at -70°C to -85°C (controls should be performed upon use when storing warmer than -70°C)
• 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

Question 9

9. Can you manufacture additional products using my originally submitted organism?

Accepted Answer

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.

Question 10

10. Do you confirm the identification of my organism when you receive it?

Accepted Answer

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.

Question 11

11. What are the required storage conditions for my CryoLC® and CryoHC® products?

Accepted Answer

CryoLC® and CryoHC® products should be stored at -70°C to -85°C.

Question 12

12. Can Cryologics ship products outside the U.S.?

Accepted Answer

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.

Frequently Asked Questions