Animal Health Is Moving Beyond Freeze-Drying — and a New Stabilization Technology Is Leading the Way

• Ambient-stable veterinary biologics are enabling the animal health industry to eliminate expenses related to cold chain dependence and unlock market distribution
• Legacy methods utilizing freeze-drying (lyophilization) cannot sustain the rapid growth of animal health product development and manufacturing due to their long development and production cycles
• Easy-to-use, standardized stabilization operations are needed to lower development costs and increase manufacturing efficiency
• Capillary-assisted vitrification (CAV) is a technically superior alternative designed to gently and quickly stabilize complex biomolecules for ambient storage and shipping, without damaging freezing steps

The global market for veterinary biologics is surging toward $25.9 billion by 2034. At the same time, disease threats are moving faster, supply chains are stretching further, and the pressure to deliver effective vaccines and biologics to remote, underserved markets — where refrigeration is unreliable or absent — has never been greater.
Against this backdrop, one thing has become clear: ambient-stable veterinary biologics are now a strategic and operational necessity.The problem, however, is that the technology most animal health manufacturers rely on to stabilize their products was never designed to support the needs of today’s animal health market.

The animal health industry is reaching a tipping point where its legacy infrastructure can no longer support its innovation. For decades, lyophilization (freeze-drying) has been the “gold standard,” yet it remains a “black box” of operational risk. Lyophilization subjects proteins and vaccines to destructive freezing steps that alter formulation chemistry. Each product requires customized excipient recipes and process parameters. For veterinary biologics or multi-component animal vaccines, achieving stability through lyophilization can prove impossible, directly limiting which therapeutics reach the market or limiting their distribution.

Each cycle exposes products to a significant risk period where power fluctuations and equipment drift create batch inconsistency. When structural collapse occurs during processing, product becomes unsalvageable. The 2-to-4-day cycles mean identifying failures and restarting production creates cascading delays impacting distribution schedules.

Most critically, lyophilized products still require cold chain distribution. Even after millions invested in freeze-drying and accepting long processing times, manufacturers deliver products demanding 2-8°C refrigeration. In some emerging markets, 20% of health facilities lack functional cold storage, and on-farm vaccine refrigerators frequently fail to maintain proper temperatures. This infrastructure gap contributes to vaccine failures, contributing to the approximately 20% of livestock lost to disease annually.

For R&D and manufacturing leaders, the question is no longer whether lyophilization can be optimized, but whether building capacity around a legacy infrastructure that comes with significant expense and 24-month lead times is worth the risk to the animal health supply chain.

Animal health manufacturers face significant financial constraints. Unlike human pharmaceuticals where high margins absorb processing costs, veterinary products operate on lean budgets that make the use of lyophilization, with its long development cycles and multi-day production turnaround times, economically challenging. Extended lyophilization timelines also limit scalability, a major contributer to profitability.

Technical limitations also hinder the transition to next-generation medicines. The freezing step in lyophilization frequently damages the lipid structures essential for mRNA vaccine delivery and can trigger aggregation in biologics. Lyophilization is difficult to optimize for complex protein mixtures, often resulting in batch-to-batch inconsistency or reduced product yields. For R&D organizations, these compatibility issues limit which candidates advance toward commercialization.

As manufacturers search for lyophilization alternatives, legacy drying methods like spray drying often introduce high-heat risks that are equally damaging to sensitive biomolecules. Even successful runs often still require refrigerated distribution to maintain long-term potency, failing to solve the infrastructure problem of cold chain dependence.

Ambient Biosciences’ Capillary-Assisted Vitrification (CAV) is engineered to replace this outdated standard, bypassing destructive freezing and delivering the operational agility required to respond to rapid market swings and disease outbreaks. Capillary-Assisted Vitrification (CAV) leverages microporous scaffolds to enable gentle drying of biomolecules, bypassing the need for freezing or heating. The flexible and efficient process is compatible with a wide range of biomolecules (antibodies, enzymes, nucleic acids, cells, and small molecules), requires minimal product-specific optimization, and is completed in under 2 hours.

Recent validation studies have demonstrated the suitability of CAV for use in stabilizing multiple vaccine formulations. For a mutant Qβ virus-like particle conjugate vaccine stabilized via CAV, mouse immunogenicity testing showed no statistically significant difference in results versus the lyophilized formulation. Biophysical characterization revealed CAV-stabilized particles maintained greater than 99% monomer content with the expected 34 nm particle size. The CAV stabilized vaccine also eliminated product loss due to structural collapse with very high resulting product yields (100%).

Compatibility with live virus vaccines represents a critical advantage for CAV compared to lyophilization. Initial early data shows retention of high yields, stability, and infectivity in CAV-stabilized live virus vaccines composed of Alpha Virus after exposure to 42°C for seven days, and for Paramyxovirus after exposure to 37°C for up to 42 days (longer term stability assessments are ongoing). Importantly, both viruses were stabilized using the same formulation and same process, a demonstration of how CAV can help standardize and increase the efficiency of manufacturing processes.

The operational transformation extends beyond manufacturing. CAV-stabilized products are suitable for ambient temperature storage, eliminating the $21 billion cold chain burden—one still required for lyophilized products. For veterinary applications where distribution extends to remote locations with unreliable refrigeration, ambient-stable products can safely reach animals in the field, helping to lessen the numbers lost to disease.

Organizations investing in lyophilization capacity commit to infrastructure that operates at a speed disadvantage and carries systematic product loss risk. While freeze-drying was once the only option, lyophilization alternatives are changing the strategic approach to biomolecule stabilization.

• Compressed Timelines: Formulation development moves faster when stabilization requires minimal optimization instead of extensive excipient screening.
• Expanded Compatibility: CAV preserves complex biomolecules that often fail during traditional freeze-drying.

• Two-Hour Processing: Manufacturers can respond to sudden demand fluctuations or disease outbreaks without overbuilding capacity.
• Repurposing Equipment: Existing lyophilizers can be leveraged to run CAV processes, enabling manufacturers to utilize current infrastructure.

• Outbreak Response Speed: Reduced stabilization development timelines with CAV allow first-to-market advantage during novel disease outbreaks, thus preventing disruptions in the livestock supply chain.
• One Health Sustainability: Ambient stability via CAV directly supports environmental and sustainability goals by eliminating the refrigerants used during lyophilization, breaking cold chain dependence, and drastically shrinking the carbon footprint of global distribution.

The lyophilization standard is failing because modern animal health requirements have evolved beyond what complex, extended lyophilization development timelines, multi-day production cycles, and cold chain dependence can support. Lyophilization now presents strategic vulnerabilities.

Ambient Biosciences’ Capillary-Assisted Vitrification addresses these constraints by delivering the processing speed, formulation flexibility, standardized operations, and ambient stability that the animal health industry requires, while removing cold chain constraints that undermine field efficacy and drive $21 billion in annual infrastructure costs.

Legacy manufacturing standards are increasingly difficult to justify in an era that demands rapid, high-yield veterinary pharmaceutical stabilization. By adopting CAV, manufacturers replace fragile, multi-day cycles and mandatory cold chain logistics with a resilient infrastructure designed for the speed of modern veterinary science.

Learn more about how Capillary-Assisted Vitrification is transforming animal health manufacturing at ambientbio.com.

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Livestock Loss and Disease Impact. Public Humanities. 2025.

Shank-Retzlaff, M., et al. Characterization and Immunogenicity of Vaccines Stabilized by Capillary Assisted Vitrification. World Vaccine Congress. 2025.

“Stabilize and Streamline: HCP Case Study with Labcorp.” Ambient Biosciences.com, 2024.