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The BioStabyl™ Process

A Commitment to Quality and Innovation

The BioStabyl™ Process reflects Hilltop Bio’s commitment to advancing regenerative medicine through science-driven innovation, rigorous quality standards, and practical solutions designed for real-world veterinary practice.

By combining biological complexity with manufacturing consistency and ease of use, Hilltop Bio helps veterinarians confidently integrate regenerative therapies into everyday care.

01

Donor Tissue Selection and Screening

Consistency begins at the source. Hilltop Bio employs stringent donor qualification protocols to ensure high-quality starting material.

  • Comprehensive health history review
  • Veterinary examination
  • Disease and pathogen screening
  • Defined acceptance criteria for source tissue eligibility

Only donor tissues that meet Hilltop Bio’s strict standards advance into manufacturing.

Dog and horse

Product capping
02

Controlled Tissue Processing and Bioengineering

Qualified donor tissue is processed under tightly controlled, aseptic conditions using proprietary bioengineering methods designed to preserve native biological signaling molecules while reducing variability and maintaining functional complexity.

Manufacturing is conducted in qualified cleanroom environments in accordance with current Good Manufacturing Practices (cGMP). Trained personnel follow strict gowning and aseptic procedures, with defined roles to ensure procedural integrity and batchto-batch consistency.

All materials are sterilized prior to use, and inprocess inspections are performed at critical stages to verify quality standards.


03

Product Characterization and Quality Assurance

Each production lot undergoes extensive characterization to ensure reproducibility and quality.

  • Quantitative and qualitative assessment of biological components
  • Verification of consistency across production lots
  • Stability and integrity testing

This characterization confirms the presence and stability of over 1,500 factors, including proteins, growth factors, exosomes, cytokines, and other biologically relevant molecules.

All Products Image

Dog with vet
04

Lyophilization for Shelf Stability

A key advantage of the BioStabyl™ Process is lyophilization, a well-established pharmaceutical technique used to improve the stability and shelf life of protein-based biologics. This process allows products to be stored long-term without freezing, reducing or eliminating the need for ultra-cold storage that complicates handling in clinical practice.

References

  1. Karunnanithy, V., Abdul Rahman, N. H. B., Abdullah, N. A. H., Fauzi, M. B., Lokanathan, Y., Min Hwei, A. N., & Maarof, M. (2024). Effectiveness of lyoprotectants in protein stabilization during lyophilization. Pharmaceutics, 16(10), 1346. https://doi.org/10.3390/pharmaceutics16101346
  2. Thakral, S., Sonje, J., Munjal, B., & Suryanarayanan, R. (2021). Stabilizers and their interaction with formulation components in frozen and freeze-dried protein formulations. Advanced Drug Delivery Reviews, 173, 1–19. https://doi.org/10.1016/j.addr.2021.03.003
  3. Li, J., Wang, H., Wang, L., Yu, D., & Zhang, X. (2024). Stabilization effects of saccharides in protein formulations: A review of sucrose, trehalose, cyclodextrins and dextrans. European Journal of Pharmaceutical Sciences, 192, 106625. https://doi.org/10.1016/j.ejps.2023.106625
  4. Wang, B., Tchessalov, S., Cicerone, M. T., Warne, N. W., & Pikal, M. J. (2008). Impact of sucrose level on storage stability of proteins in freeze-dried solids: II. Correlation of aggregation rate with protein structure and molecular mobility. Journal of Pharmaceutical Sciences. https://tsapps.nist.gov/publication/get_pdf.cfm? pub_id=854104