Agno Pharmaceuticals

Agno Pharmaceuticals is a CDMO that specializes in the development and manufacturing of complex dosage forms. Based in the United States, they function as a partner supporting the preclinical stage through GLP-compliant investigational drug product and API supply. This article introduces the characteristics of Agno Pharmaceuticals' non-clinical testing.

Features of Agno Pharmaceuticals' Non-clinical Testing Contract Services

Rapid manufacturing of GLP-compliant batches

Agno Pharmaceuticals isAble to rapidly manufacture API and intermediate batches that comply with GLP (Good Laboratory Practice) required for non-clinical studies.This is a significant strength. We optimize synthesis routes and develop processes from the early stages, carrying out manufacturing design with scale-up in mind. We can ensure quality and reproducibility not limited to supplying test samples, but with future clinical trials and commercial production transitions in view. Manufacturing and record-keeping comply with GLP requirements under our quality assurance system, providing high reliability for regulatory compliance and a solid foundation for smooth preclinical studies.

Development and supply of test articles for GLP toxicity studies

We support the development and supply of test articles used in GLP toxicity studies, playing a crucial role in the preclinical stage.Rather than simply providing the active pharmaceutical ingredient, we design and optimize it into a dosage form suitable for the actual route of administration and test conditions.We prepare materials for use in in vivo and in vitro testing. We can handle both sterile and non-sterile preparations, and utilize formulation technology to address challenges such as solubility and stability. We also support complex drug delivery technologies like nanoparticles and sustained-release formulations, and can flexibly handle projects involving poorly soluble or highly potent compounds. Supplies are produced and quality-controlled in accordance with GLP requirements, ensuring high regulatory compliance and providing a foundation for the accuracy and reproducibility of toxicity studies.

Integrated support from prototype design to scale-up

Consistent support from prototype formulation design to scale-up for preclinical testingWhat we can do is also one of our strengths. In the early stages, we design an appropriate dosage form based on the properties of the active ingredient, the route of administration, and the purpose of the study, and use formulation technology to address challenges such as solubility and stability. We then develop the formulated prototype not just as a test sample, but into a process design that considers clinical trials and future commercial production. This allows for risk reduction during scale-up and ensures reproducibility. By systematically verifying manufacturing conditions and quality characteristics, we achieve both development efficiency and consistent quality, supporting a smooth transition from preclinical to clinical development.

Handling highly difficult projects with advanced formulation technology and analytical infrastructure.

possessing diverse drug delivery technologies such as nanoparticulation, emulsification, gelation, hot-melt extrusion, and nanonillingWe can also handle difficult-to-handle substances such as poorly soluble compounds and highly potent active pharmaceutical ingredients (HPAPIs). We prepare candidate compounds that are difficult to evaluate with conventional methods for non-clinical testing through appropriate dosage form design. We also provide analytical services such as method development and validation, and stability testing (in compliance with ICH guidelines), ensuring both quality evaluation and data reliability. Our integrated technical platform allows for flexible responses to complex formulations and tests under special conditions.

An example of a disease model owned by Agno Pharmaceuticals

The pathological models I possess are not listed on the official website.

Agno Pharmaceuticals Non-clinical Trial Case Studies

Information on non-clinical study examples was not available on the official website.

Agno Pharmaceuticals Company Information