Manufacturing of Additional Pooled Cryoprecipitate
Vitalant began manufacturing pooled cryoprecipitate (pooled cryo) from plasma frozen within 24 hours. Adding this manufacturing option will help alleviate ongoing pooled cryo inventory pressures.
Is this a different product than the pooled cryo I receive now?
This pooled cryo is the same product you receive now. The only difference is the plasma source – this pooled cryo variation is manufactured from plasma frozen within 24 hours versus 8 hours.
Although there is a variance on the source of the product, the product ISBT code is the same. The minimal quality control criteria remains the same.
Will my hospital receive pooled cryo from plasma frozen within 24 hours?
Vitalant will begin manufacturing pooled cryo from plasma frozen within 24 hours at our El Paso, Texas location. Our El Paso team will complete the initial validation and licensure process for submission to FDA. Licensure approval from the FDA may take up to an additional 18 months. While awaiting FDA approval Vitalant will be able to manufacture cryo products from plasma frozen within 24 hours as “unlicensed” products with an initial distribution limited to facilities in Texas. During this time, El Paso will continue to manufacture licensed pooled cryo from plasma frozen within 8 hours, which will be able to support the national footprint.
Every organization, however, will benefit from this manufacturing change. Vitalant is identifying additional manufacturing sites to expand production across our national footprint. As El Paso and subsequent sites begin manufacturing pooled cryo from plasma frozen within 24 hours, our entire national pooled cryo inventory - whether from plasma frozen within 8 or 24 hours - will increase and availability should improve for all customers.
What does my organization need to do to prepare to receive pooled cryo from plasma frozen within 24 hours?
- Share this information within your facility with key stakeholders who request, accept and utilize pooled cryo.
- Continue to monitor communications from Vitalant to stay up to date on national inventory levels for pooled cryo.
Thank you for your continued partnership. Please reach out to your local Vitalant contacts with questions.