Animal Health: How Pharma Processing Facilities Are Supporting Animal Wellness

As our lives become more entwined with animals’, their health becomes increasingly more important.

This is the cornerstone of the One Health approach that the CDC advocates: “the health of people is closely connected to the health of animals and our shared environment.” We have become more dependent on livestock and more invested in our pets. We have also seen that this close contact with animals opens humans up to more opportunities for diseases to spread from the former to the latter. For these reasons, the animal health sector is rapidly evolving to better serve us all.

Still, there is a lingering misconception is that animal health is a less complex and stringent version of human health. In reality, manufacturing food and pharmaceuticals for animals involves product regulations, aseptic procedures, and testing nearly as rigorous as for human products. Out of necessity, it’s also implementing many of the cutting-edge advances made in human health, as well as responding to rapidly changing consumer demands. At the same time, the animal health sector has different constraints, especially when it comes to profit margins.

For example, livestock farmers and pet owners are looking for different things from animal pharmaceuticals. While livestock owners want cost effectiveness, pet owners want cutting-edge, high-quality medicine—at almost any cost. Pharma manufacturers must balance all of these factors when determining what they will develop and manufacture, as well as how they will set up their manufacturing operations.

Given how broad this market has become, we’ve constrained this article to just the pharmaceutical trends and facility considerations. For more reading on trends in and the manufacture of pet food, check out these other articles:

Consumer trends and what they mean for pet food processing

The making of a modern pet food processing plant

From preventive measures to life-saving treatments, animal health covers a diverse range of products. This requires flexible production spaces which, in turn, can create additional complexity. This is a broad overview of those products, as well as the process and facility considerations animal health manufacturers face.

Trends in pharmaceutical products for animal health

The animal pharmaceutical market serves a wide variety of needs across livestock (e.g., cows, chickens, and pigs) and companion animals (e.g., dogs, cats, and horses). The industry is tackling a huge range of veterinary conditions and treatments, from bird flu to canine pain medications.

These are some of the trends and advances being made within pharmaceuticals for both livestock and companion animals.

Pharmaceutical concerns for livestock

Farmers, ranchers, and food producers are in a high-volume, low-margin business. As such, they are practical clients looking for cost-effective solutions that keep animals healthy for their entire lifetime.

Pharma doses for many agricultural animals are larger than for humans—much larger. Just consider the weight difference between a 150-lb person and an 800-lb cow. These doses must also be administered at scale—flocks and herds can number in the hundreds. Pharma producers need to support higher dosing volumes. But margins are so slim on the production of livestock medicines that manufacturing costs must be kept low.

To make it profitable for the pharma producer, the facility must be right-sized. This means building a facility that closely matches the number of doses produced to the number required. One way to address the slim margins when renovating or building an animal pharma facility is pursuing a target value delivery approach. Parameters around cost, schedule, and outcomes are set by a collaborative team at the beginning of the project, and these guide decision-making throughout all phases of design and construction.

Trends in livestock pharmaceuticals

• Vaccinations: Trough or mass vaccinations are a growing trend for livestock to limit human exposure to the herd. This approach, as opposed to injecting every animal individually is not only safer for veterinarians and cattle farmers, but it’s also better for animal welfare.

• Feed additives & fortified foods: Feed additives are now used as a delivery method for medicine and can replace the need for a consulting veterinarian in some cases. For example, one company has genetically modified sorghum to produce a medicine that is usually delivered intravenously to cattle. In this way, farmers can medicate an entire herd simultaneously. Fortified foods are increasingly used to deliver healthy cattle to the slaughterhouse. This nutraceutical approach replaces synthesized hormones to “beef up” cattle. While not everything can be administered as a feed additive—some nutrients and medicines cannot survive passing through the gut—it works well in some applications.

• DNA sequencing: Due to the low cost of, and easy access to, DNA sequencing, farmers can use a fur or saliva sample from their herd to identify which diseases their livestock are prone to develop. It can even be used to develop a customized, herd-specific vaccine. This allows for rapid data collection and different drug products to manage herd ailments for a specific breed, such as brown, black, or angus cattle. This targeted approach to treatment is cost-effective as it negates the need to blanket a herd with coverage for every suspected ailment. Some companies only need ten weeks from receiving a DNA sample to shipping out a customized vaccine.

Pharmaceutical concerns for companion animals

Achieving or maintaining optimal animal health is the ultimate goal with both livestock and companion animals, but the circumstances are very different which produces different concerns for consumers and manufacturers. Simply put, pet owners have fewer animals to care for and may be less concerned with finding the most economical solution.

In fact, spending on companion animals is up—pet owners are investing more money into their pets’ food, toys, health, and more. Notably, interest in pet supplements and pet insurance has increased, demonstrating that consumers are trying a wider variety of animal health products, and they may be more willing to invest in higher-priced animal health measures. For manufacturers, this means added complexity in their product pipelines.

Trends in companion animal pharmaceuticals

The market trend for companion animals is moving towards reduced volume of oral vaccinations due to the difficulty in vaccinating companion animals. The smaller the dose the easier it is to administer and it reduces the worry of getting the companion animal to take half the dose and refuse the rest.

Pet purchase trend: the pandemic puppy

Interest in pharmaceuticals for companion animals reached new heights during the pandemic when remote working and isolation triggered massive interest in “pandemic puppies.” The effects will likely be long-lasting, as owners look for high-quality products over their pet’s lifetime.

Companion animal medications include:

• OTC (flea/tick and heartworm).
• Vaccines (rabies, etc.)
• Canine dermatitis
• Pain management (arthritis e.g., Labrella/nerve growth factor (NGF))

Monoclonal antibodies: Monoclonal antibodies (mAbs) are emerging as the next mainstream platform for animal health. While this drug category has existed in human medicine for almost three decades, much of the animal health industry has stuck with tried-and-true means of vaccine production. However, the single-use technology may enable commercial-scale mAb production with lower up-front costs. As such, mAbs are now being approved for pain management for companion animals and other possible veterinary applications are under exploration, including allergies, osteoarthritis, autoimmune diseases, neoplasia, and dermatitis. Pharma producers are making massive investments in companies that can create these drugs.

Gene therapy: The advanced therapy medicinal product (ATMP) side of animal health is emerging as pet owners are increasingly willing to invest in their pets. Of course, personalized medicine technologies are not new, but it is still a rapidly changing and developing area for researchers and manufacturers. Currently, gene therapy in the animal health space is being driven forward by smaller startups who are pursuing one indication. For example, one animal pharma company focuses solely on pancreatic cancer in dogs with an autologous therapy, while another zeros in on feline leukemia by using samples to develop personalized treatments for these animals.

Orphan drugs: Finding a way to repurpose human drugs that are not yet used in the animal health market is increasingly popular. For example, Diltiazem was used extensively for human heart disease ten years ago. Now it is being used off-label for certain cardiac and vascular ailments in cats, dogs, and even ferrets. As animal health researchers look at side treatments of orphan drugs, they are finding effective solutions for a wide array of animal illnesses. Of course, this requires investment as there is extensive research, development, and production involved in finding the right dosage and scale as a drug moves from human to animal use.

Single-use technology: Increased throughput within animal pharma is driving the transition to single-use technology. For example, using a plastic bag in a single-use bioreactor allows pharma facilities to switch from Product A to B quickly. This allows for more efficient use of equipment, greater ease to accommodate shifting regulatory requirements, lowered risk of cross-contamination, and reduced downtime, making for cost-effective and efficient processes.

Single-use technology lowers capital costs. It increases operational cost and waste since new supplies must be purchased for every batch—but these don’t need to be cleaned or stored long-term.

Animal pharma facility considerations

As large human pharmaceutical companies branched off into animal pharmaceuticals the initial trend was to bring along all of the corresponding regulatory guidance. While this may allow for initially, it can make future changes to the facility difficult. So it’s a better idea to simply build to a good base standard.

An affordable facility requires judicious use of capital. For example, it may be better to simply install a biosafety cabinet (BSC) rather than an isolator when appropriate. Or perhaps less expensive building material can be used—not every finish needs to be stainless steel; not every floor needs to be epoxy. A balanced, profitable approach calls for identifying risk points and addressing these carefully.

Regulatory

In the U.S., pharmaceutical products for livestock must meet USDA regulatory requirements, while most companion animal pharmaceuticals must meet FDA regulations. Both sets of regulations are stringent, with animal pharmaceutical producers facing the threat of fines or even shut down if they are not compliant.

Although there are differences between USDA and FDA regulations, most of the differences relate to containment. For example, FDA products are tightly regulated both upstream and downstream. Further, depending on the type of product (oral solid dosage, vaccine, etc.), the FDA will require more control of cross-contamination and separation. The USDA will also want to control cross-contamination; however, for livestock pharmaceuticals, it’s very practical and common to make 20+ different antigens in one type of production space—a ballroom. Because FDA-regulated products require stricter controls over the separation of materials and personnel flows, these facilities typically have separate areas/processes for the different antigens.

Some mature manufacturers are opting to build to FDA standards although their current animal pharmaceuticals only require USDA regulations. Meanwhile, early-stage companies tend to opt for the slightly lower USDA standards which still address safety, etc. Ultimately, neither route provides significant cost savings over the other. The separation and airlocking required by FDA regulations increase costs, but so does the complexity of making 20+ different antigens work in one lab, as is the case for many USDA-regulated facilities.

Equipment selection

When it comes to facility equipment and processes, there is a lot of crossover between animal and human health. One difference is in the calibration and validation of equipment. While limit stops on valves might be used in some human health facilities, these are rarely used in animal health facilities. Another difference is in packaging and labeling. Since veterinary pharma offers a huge selection of products, packaging can be an important selling point for consumers. For example, the easier it is for a vet to administer a product given its packaging, the more likely the vet will continue to buy that product. So this is a much more significant consideration for animal health manufacturers.

Data

Data collection, protection, and integrity are hot topics in animal health. Facilities are increasingly asking questions such as: If we’re measuring various aspects of our process, how is that data stored? Do we really trust that data?

Increasingly, animal pharma facilities are using software, hardware, and protected networks to ensure data safety. While data safety requires greater measures nowadays, it also is bringing rapid answers that weren’t possible five years ago.

Overall, animal health is becoming much more sophisticated. It’s important for facility decision-makers to remember, however, that it is a separate industry from human health. While a safe, thoughtful, and efficient approach is required, it does not require an identical level of regulatory oversight and quality. This explains why many veterinary pharma companies are finding success decoupling from their human pharma counterparts.

While at first, some large human pharmaceutical companies tried to branch off into animal health, bringing all their human health regulatory standards with them, it quickly became clear that this approach was neither necessary nor profitable. We’ve seen greater success in the marketplace in recent times as companies break away from their human health counterparts and create separate, independent facilities that meet the unique needs of animal health.