Core Competencies
Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.
APIs including New Chemical Entities and Generics
Chemical Development Phase-Appropriate Process and Analytical Method Development
Regulatory Starting Materials
Non-GMP and GMP Manufacturing Suited for Preclinical, Clinical, and Commercial Batches
Intermediate Development and Manufacturing
Stability Studies & Regulatory Compliance ICH Stability of APIs and Intermediates
Intermediates are custom synthesized compounds made specifically to API process requirements
Using the established regulatory procedures these can be designated as RSMs and we offer the client the services of gaining the necessary knowledge about the manufacturing process, impurity purging, and other requirements to secure the RSM status.
Agno Pharma has the expertise and experience in developing and manufacturing APIs for clients in the various phases of drug development from the initial pre-clinical to commercial APIs.
We have the proven ability to overcome numerous challenges
In the development and manufacturing of cytotoxic and highly potent compounds there are many challenges.
Facility design, engineering controls, suitable equipment, and the proper operation of facilities and equipment are required to achieve the desired containment level in HPAPI (High Potency API) manufacturing.
Operator safety is critical when handling, storing, and contaminating highly potent compounds, especially up to OEB 5 (Occupational Exposure Band 5) compounds. To this end the operators are trained in the handling of HPAPIs, along with execution of safe-handling practices and CGMPs to prevent contamination and exposure. cGMP-compliant isolators integrated within the dedicated high potency suites with reactors up to 500 L in size are the foundation for the manufacturing of highly-potent compounds at Agno Pharma.
Another key challenge in developing highly-potent compounds is creating sufficiently sensitive analytical methods to detect potential genotoxic impurities (PGIs), often at low ppm levels. Agno Pharma has the analytical expertise, experience, and advanced instrumentation to address this effectively.
We also offer sterile APIs to support a range of sterile drug products, including injectables. Our established in-house aseptic processing and sterile fill capabilities supplement our API sterile manufacturing services.
Agno Pharma leads with a phase-based approach
Our approach goes beyond conventional standards, facilitating a seamless transition from early clinical development to commercial manufacturing.
Our cross-functional project team brings together experts from statistics, Environmental Health & Safety (EHS), Quality & Regulatory Affairs, Sourcing, and Business Development. This collaborative approach ensures streamlined project progression and expedites advancement from R&D into clinical.