Author: Marc Bordelon, DVM, MBA

Overview

Hilltop Bio products are derived exclusively from equine birth tissues and are developed with a primary commitment to animal welfare, donor safety, and product quality. All collections occur during live foalings, and the health and wellbeing of the mare and foal always take absolute priority over tissue collection. At no time are collection activities permitted to interfere with veterinary care or the natural birthing process.

All Hilltop Bio products are manufactured in a GMP-aligned facility operating under a controlled quality system designed to support consistency, safety, traceability, and quality throughout the product lifecycle.

Commitment to Animal Welfare and Donor Eligibility

Only healthy mares and foals are considered eligible as tissue donors. Donor selection is conducted under veterinary oversight and is based on health status at the time of foaling, delivery conditions, and comprehensive disease screening. Birth tissues are collected exclusively from normal, live vaginal deliveries on working farms.

Because animal welfare is paramount, collections are performed only when conditions allow and under appropriate veterinary supervision. Tissue collection is secondary to the wellbeing of both mare and foal.

Tissue Collection, Handling, and Transport

Equine birth tissues are collected immediately following delivery using controlled collection practices. Following collection, tissues are placed into validated containers and shipped on ice to the Hilltop facility to preserve tissue integrity during transport.

Upon receipt, tissues are logged into Hilltop’s traceability system, inspected, and stored under controlled conditions pending testing and review.

Donor Disease Screening and Testing

To reduce the risk of transmissible disease, blood samples from donor mares are tested by an independent third-party laboratory immediately prior to foaling. Disease screening includes, but is not limited to:

• Equine Infectious Anemia (Coggins test)
• Piroplasmosis
• Brucella
• Parvovirus
• Anaplasma phagocytophilum
• Lyme disease
• Hepacivirus
• Equine Viral Arteritis
• Vesicular Stomatitis
• Equine Rhinitis
• Equine Herpesvirus (Types 1, 4, and 5)

Only donors that meet all disease screening requirements are considered eligible for further evaluation.

Incoming Tissue Review and Medical Oversight

Because tissues are collected during vaginal farm births, a natural level of background bioburden is expected. Incoming tissues are therefore evaluated against established internal acceptance criteria to confirm suitability for processing.

Donor disease screening results, incoming tissue testing data, and veterinary delivery reports are reviewed by Hilltop Bio’s medical director. Donor material is approved for processing only after this comprehensive review and formal clearance.

Processing Controls and Sterility Testing

Approved donor material is processed under controlled conditions in Hilltop Bio’s GMP-aligned manufacturing facility. Prior to commercial release, final product lots undergo a 14-day sterility test performed by an independent third-party laboratory.

Products are released only after sterility requirements are met and all quality review steps are successfully completed.

Product Characterization and Quality Testing

In addition to sterility testing, Hilltop Bio performs internal analytical testing to confirm that products meet established specifications. These evaluations assess the presence and consistency of key proteins and growth factors relevant to product quality and performance.