Services
Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.
Feasibility screens
High-Potency API Production
Process Performance Qualification
Sterile API Manufacturing
Continued Process Verification
Intermediate and Pilot Production
Our Process
Upon receiving NDA approval for the sale of a commercial drug, the Process Performance Qualification (PPQ) batches, once successfully completed, are utilized in the production of the commercial drug product. As production volumes increase annually and data from process and release testing accumulate, Agno Pharma implements a Continued Process Verification (CPV) program to scale with our clients’ requirements. This initiative ensures that the manufacturing process remains validated and capable of maintaining product quality over time by identifying and addressing any long-term trends that might affect process control.
Our State-of-the-Art Equipment
Our commercial facility is outfitted with state-of-the-art production equipment across various lines, ensuring comprehensive capabilities for diverse manufacturing needs. The major equipment includes:
- Reactor Systems for diverse scale-up needs from 50 L to 8000 L that support batches ranging from 1 Kg to 1800 Kg.
- Intermediate Pilot Workshops facilitates the initial production phases.
- Intermediate Production Workshops designed for scaling up processes for clinical and commercial supply.
- API Line with batch sizes ranging from 1 Kg to 1800 Kg, accommodating standard API production.
- Non-Sterile high potency dedicated to producing HPAPI APIs up to OEB 5 with containment down to 0.1 ug/m3 with batch sizes from hundreds of grams to 15 Kg.
- Sterile API high potency supporting cytotoxic and HPAPI APIs up to OEB 5 with batch sizes from hundreds of grams to 25 Kg.
- Sterile API dedicated to standard API production with batch sizes ranging from hundreds of grams to 25 Kg.
- Sterile Powder-Fill Line for cytotoxins with dual dosing heads, providing precise filling capabilities up to 25,000 vials per batch.
This sterile powder-fill line ensures that Agno Pharma can meet a wide range of production requirements, maintaining the highest standards of quality and compliance in cGMP manufacturing.
