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Solid Phase Peptide Synthesis Services

We provide a wide range of solid phase peptide synthesis for linear and branched chain peptides on small scale up to 70 AA, as well as development and manufacturing up to 40 AA. Aurigene Pharmaceutical Services uses automated peptide synthesizers (80-160 L) and small-scale equipment to produce research-grade material and the development of process designs. Multi-gram to multi-kilogram production for toxicology studies and clinical trials are typically performed by solid-phase synthesis and corresponding cleavage systems. Understanding the thermal sensitivity of the compounds, we use lyophilization (Capacity: 3 x 100 L) to isolate the final product.

 

Microwave peptide synthesis

 

With a capacity of up to 15 L, our microwave mediated peptide synthesizer (Liberty Pro) has become an established technology, which facilitates challenging couplings and drastically reduces the peptide synthesis time.

 

Our offering includes:

 

Synthesis of peptide APIs, NCEs and other services

  • cGMP manufacturing of peptide NCEs, APIs and building blocks
  • Route scouting, development, and validation
  • Manufacturing of complex peptides

Analytical development

 
  • Analytical method development and validation
  • Stability studies
  • Impurity profiling and validation
  • Supply of analytical reference standards
 

Drug Product Support:

 

Our integrated API and formulation services for peptides provide a holistic approach from early API and formulation development and can accelerate your timelines while offering technical and cost advantages.

 

Quality and regulatory expertise:

 

As a CDMO, we are highly regulated by global agencies to ensure the safety and quality of our products. All our cGMP manufacturing facilities are regularly inspected by global regulatory authorities including the US FDA, MHRA or TGA.


Our regulatory team works closely with your CMC teams and has a track record of numerous DMF, IND, NDA and IMPD filings.

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