Animal Health

Supporting the development of animal health products through digital twins, microstructure analysis, and in silico release prediction.

Issue

Just like people, our four footed friends have their own medicinal needs. Animal health products span a wide array of dosage forms and unique technologies to deliver the active ingredient, including flea collars, controlled intravaginal drug release (CIDR) devices for cattle, long-acting implants, and chewables for dogs. These complex products must be carefully formulated and designed to be competitive within the market and provide safe, efficacious delivery. Along the way, an array of challenges in formulation selection, process optimization, scale up variability, and long testing cycles can occur.

Common Challenges

Downstream manufacturability and quality issues rooted in oversimplified formulation strategies
Dissolution variability during scale up and technology transfer
Long development times and resources spent optimizing manufacturing
Lack of discriminatory in vitro methods to guide formulation and anticipate in vivo performance

Solution

Our mission is to accelerate our partners' product development and reduce resources spent during these pinch points with the use of digital twins, microstructure analysis, and in silico release prediction. To overcome the complexities of animal health product development we apply a quality by design approach integrating a microstructure feedback loop. We apply advanced microscopic analysis such as FIB-SEM and X-ray micro-CT to quantify the size, distribution, and interaction of ingredients and porosity within the final drug product. Microstructure digitization provides dozens of critical quality attributes to evaluate product performance and quality, serving as a data rich input for QbD integration. For controlled release platforms, we predict release profiles in a matter of days, using the real digitized microstructures to simulate transport phenomena. This can eliminate the need for long in vitro tests during formulation and process selection stages. We also study post-partial release samples from in vivo and in vitro studies, enabling quantification of the drug dissolution front, polymer degradation, and other structural changes that can occur. This analysis can offer insights into the impact of the in vivo environment on release and can support the pharmacokinetic data.

In addition to our analysis services, we support the assembly of simulated release profiles and microstructure analysis into data packages for NDA and ANDA filings. We provide services for pet care and livestock animal health products and across nearly all dosage forms.

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Our Approach

Guide formulation design through quantitative analysis of ingredient interactions
De-risk scale up and tech transfer challenges with structural benchmarks
Build correlative process models to identify critical process parameters and critical quality attributes
Predict dissolution, disintegration, and release phenomena from microstructure digital twins

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