Safety-More than just our number value at AniCell

Safety Starts at Home

One of AniCell’s Core Values is Safely Extending ACTIVE life with Innovative Solutions. This value is foundational to everything we do at AniCell and begins with our collection facility. Many have asked if we get our products from an equine reproduction facility. While that would certainly be much easier and less expensive, AniCell has chosen safety over ease by retaining the complete “chain of custody” of its collected material from the time the mares show up on the ranch to the final AniCell product that arrives at the clinic.

The Miracle Ranch is a closed specialized birthing facility owned and operated by AniCell and designed to safely collect the raw material for our products. This facility is home to no horses except those pre-screened mares who arrive during foaling and collection season, significantly reducing the risk of communicable diseases that could inadvertently be spread through the water or the ground. All surfaces are cleaned and disinfected prior to the next mare arriving at the Miracle Ranch.

In accordance with AniCell’s Core Values, we instituted these labor-intensive safety measures because amnion is Allogeneic in nature; from one donor to another patient. To ensure product safety, we must rigorously screen and test at various stages of the collection process. Prior to arriving on the Miracle Ranch, AniCell pre-screens and tests pregnant donor mares that owners graciously loan to us the last month of their pregnancy. This battery of tests is identical to tests that are performed by blood plasma facilities prior to blood donors arriving at plasma farms. By treating our collection facility like a blood plasma facility–isolated from many of the communicable diseases that could be spread between horses in a traditional boarding facility– we control the handling of tissue material through our supply chain, from the collection of amnion tissue to aseptic processing in our laboratory to packaging and sterilization, and guarantees an unbroken chain-of-custody among other quality assurance measures.

Once parturition occurs, the mares and the raw materials are tested again to ensure the donor amnion material is aseptic and safe for processing. The healthy mare and foal return home to their owners two days after birth.

Originally Published Summer 2018 – https://anicellbiotech.com/anicell-summer-2018-update/

Product Testing

Again, to uphold our Core Value of Safety, AniCell performs a quality control check at every stage of product processing. These quality checks include not only internal safety measures but also product testing done externally through third-party labs to ensure independent corroboration of our results. For our implantable products, these third-party labs test for both bacterial and fungal bioburden, LAL-endotoxins content, and any incidence of mycoplasma contamination. Our biological bandage products including BioScaff, StemWrap, and AniOcular are sent off for terminal sterilization using Electron Beam Irradiation. All these safety steps are in accordance with the American Association of Tissue Banks and FDA Current Good Manufacturing Practices.

Originally Published Fall 2018 – https://anicellbiotech.com/anicell-fall-2018-update/

Testing Transparency with the Certificate of Analysis

We believe that all our safety processes should elevate our level of transparency. Our Certificate of Analysis is the vehicle we use to compile both our donor and product lot test results. This certificate summarizes all our results in one place giving our customers the confidence that every lot has passed both the industry’s and AniCell’s stringent assay requirements for biological products.

We believe that this transparency will ease any concerns one may have about using allogeneic products and will continue to set the bar for safety and quality in the industry. Please take a look at our example at www.anicellbiotech.com/cert-of-analysis/.

Originally Published Winter 2019 – https://anicellbiotech.com/anicell-winter-2019-update/

Product Efficacy and Safety

Finally, we endeavor to collect data on as many of the product applications as possible. By tracking product efficacy and safety of our products out to 120 days, we can follow up on results per indication and can monitor any safety issues associated with our products. While we are not able to get feedback on every case, AniCell currently is garnering a 31.03% response rate with an over 94% success rate.

AniCell tracks the outcomes of our products by serial number and indication to ensure our products are achieving the absolute best outcomes. We stand behind our products by re-treating cases that did not achieve the expected outcomes. We do this free of charge to the veterinarian and will even go as far as guaranteeing the results on our proven indications by refunding the purchase price to the veterinarian.

We understand that all cases are not able to come back to previous performance levels. Through familiarity with the products and good case selection, veterinarians have been able to realize above a 90% success rate on the tendon, ligament, joint, bone, superficial wound, and ocular injuries outperforming the existing standard of care.

As the pioneer of amnion products in Animal Health, AniCell has endeavored to not just have better products but to be a better company. With over 8000 applications to date, we will continue to lead the veterinary industry with field-ready products able to be used the same day as diagnosis.

Originally Published Spring 2019 – https://anicellbiotech.com/anicell-spring-2019-update/