Services
Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.
Full Development Spectrum from R&D to GLP to GMP and Commercial QC
Informal and ICH-Compliant Stability Programs
Wide Range of Analytical and Physicochemical Characterization Equipment
FDA-Approved and DEA-Licensed for all Schedules
Expert in Sample Preparation of Complex Form Factors
Expertise in Analytical Method Development and Validation
Our Team of Scientists
Our team of formulation development and process scientists collaborates closely with analytical services to devise customized analytical methods aimed at characterizing and understanding intermediates, regulatory starting materials (RSMs), active pharmaceutical ingredients (APIs), and finished dosage forms (Drug Product, DP). Working with Agno Pharma gives you a strategic partner dedicated to meeting both the short-term project needs and long-term success in pharmaceutical development.
Additional Services
Our chemical characterization capabilities allow us to fully support the process development and manufacturing services offered by Agno Pharma. This includes supporting chemical process development, and optimization, tech transfer and scale-up, particle engineering optimization, and GLP/cGMP testing. We excel in analytical method development and validation, ranging from initial research-level approaches to fully validated methods crucial for assessing stability and performance ranging from intermediates and API to various dosage . Our capabilities include HPLC, uPLC, GC, KF and potentiometric titrators, various chromatographic detectors such as PDA (photodiode array), UV-vis and IR, ICP-MS, TOC analyzer, evaporative light scattering, refractive index, fluorescence, and mass spectrometry. For dissolution testing, we have USP apparatus 1, 2, 4, and 5.
The QC laboratory manages electronic data for HPLC/uPLC/GC through Chromeleon 7.2 SR4 and Agilent OpenLab CDS 2.3 Network Edition. All employ electronic data management with permission-level access control, audit tracking management.
Our drug product physical characterization lab is a natural extension of our analytical capabilities. We support formulation development and monitor stability through particle size distribution (optical microscopy), rheological analysis, and solid-state characterization. We have in-house expertise with DSC, TGA, Raman microscopy, and other methods that support evaluations of key properties such as crystallinity and solubility.
We are adept at working with complex dosage forms, ranging from intravitreal injectables to nanosuspensions to long-acting implantables. With decades of drug-device combination product development experience, we are uniquely positioned to perform mechanical property testing on products such as vaginal rings and subcutaneous implants.
Our data-driven approach allows us to develop a robust characterization plan for your product. Our experience with a broad range of APIs and drug products ensures that suitable methods are selected.
