GMP Manufacturing

Process Development

Auspep Clinical Peptides specialises in the development and scale-up of peptidic Active Pharmaceutical Ingredients (APIs) in compliance with local and international regulators.

Auspep has the expertise and facilities to assist the client during all facets of product development. We work on the principle of partnering with our clients.

Our portfolio of clients ranges from small R&D biotechnology companies to large multinational drug companies.

Scale-Up (Contract Production) APIs

Auspep has the capability to manufacture peptides from clinical scale (milligrams) to commercial scale (kilograms) using solid phase peptide synthesis. Our GMP facilities contain multiple rooms for batch specific tasks. Rooms have been designed to meet Class 350 (Grade C) and Class 3500 (Grade D). Systems have been put in to place to eliminate the possibility of cross contamination.

Key equipment includes GC, analytical HPLC systems, small and large scale preparative HPLC systems, manifold and shelf freeze dryers and LCMS systems.

 

 
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