Frequently Asked Questions

What is Signature Biologics?

Signature Biologics is a biotechnology company specializing in the production of placental derived products and a registered tissue bank with the FDA
(FEI: 3014452510).

What is special about perinatal tissue?

Perinatal tissue offers a variety of structural tissue constructs; amniotic membrane and umbilical cord. These tissues are immuno camouflaged (lack HLA) to protect the child from the mother’s immune system during gestation. They are also naturally rich in growth factors, cytokines and more.

What is the chain of custody for tissue used in our products?

Our tissue is acquired from licensed third parties whom specialize in tissue acquisition. Once tissue is received the processing, storage, and distribution is all handled within the Signature Biologics Quality Management System.

How are the products regulated / what category of product(s) is this?

Signature Cord and Signature Matrix products are designed under Section 361 of the Public Health Service Act according to 21 CFR Part 1271.10.

Do your products have live cells?

The donor tissue contains live cells and we strive to maintain the integrity of the raw material. This allows preservation of the original tissue structural components and viability.

Do you have quality control materials / release criteria?

Signature Biologics follows strict quality control guidelines in donor eligibility, tissue handling, transmittable disease screening, bio-burden reduction and end-to-end traceability. All product is quarantined until third party testing is completed for release and eligibility is approved by our Medical Director.
For more information on our process, please see Our Process page.

How are the products standardized to a Unit of Measure?

Signature Biologics allocates product to each vial based on tissue weight (expressed in milligrams). This allows for scientific certainty of tissue quantity present in each vial produced. Please see the Products page for the individual product’s packaged tissue weight.

Are the products immune evasive?

Perinatal tissue offers a variety of structural tissue constructs; amniotic membrane and umbilical cord. These tissues are immuno camouflaged (lack HLA) to protect the child from the mother’s immune system during gestation. They are also naturally rich in growth factors, cytokines and more.

Are the products absent of contamination?

Our products are processed under validated aseptic conditions. A statistically significant portion of each lot is tested for sterility by a third party CLIA certified laboratory to ensure absence of any bio-burden. The external container (vial) has been validated to ensure it keeps the sterility of its contents. The vial is then stored in a sterile sealed pouch as a secondary barrier. More information can be found in the package insert.

How are orders placed?

Orders should be place via emailing an order form to info@signaturebiologics.com.

How are the products shipped?

The products are shipped overnight on dry ice. Two shipping methods are available today*:
1) FedEx Priority Overnight (10:30 AM Delivery)
2) FedEx First Overnight (08:00 AM Delivery)
*Extra Dry Ice Available Upon Request.

How are the products stored?

The product should be kept stored at a minimum of -65°C and thawed prior to use. Thawing instructions can be found in the package insert.

Are the products covered by insurance?

Most insurance agents consider this treatment an investigational therapy and are therefore unlikely to cover the costs of the biologics product. Some private insurers are beginning to integrate these offerings into their plans. When considering any medical procedure, patients should always consult their insurance provider to find out what is covered by insurance and what is not. As more research studies become available and demonstrate efficacy, it is expected that more and more insurance carriers will begin to cover the costs associated with structure tissue allografts.

Do you have any samples?

We currently do not offer samples. Please contact Signature Biologics and ask to speak with our Sales Department about evaluating our products within your medical practice for more details.

What volume sizes do your products come in?

Our products are packed in 1.0 mL and 1.5 mL vials. Please see our Products page for more details.