Peptides

We help to accelerate the time-to-market of your peptide APIs and formulations

Dr. Reddy’s peptide unit has decades of experience in process development and production of peptide APIs and formulations. This experience is brought to bear on a comprehensive offering that integrates a continuum of services for custom peptide synthesis including:

• route design
• feasibility studies
• process development
• process optimization and validation
• commercial manufacturing
• regulatory and marketing support

Our scientists and dedicated project managers leverage Dr. Reddy’s experience in complex organic chemistry combined with versatile capabilities and scales for production. Dr. Reddy’s development of new peptide generics creates continuous innovation and knowledge expansion in chemistries and technologies. This innovation is a result of internal research projects and collaboration with external research institutions – all of which helps to improve processes with new peptide engineering and manufacturing solutions (e.g. continuous solid-phase synthesis).

Peptide services seamlessly integrate with Dr. Reddy’s capabilities in activated mPEGs, special chiral building blocks including carbohydrates, and handling of highly potent APIs (HPAPIs) that can include non-amino acids, cyclization or conjugations. Our services include:

Solid-phase Peptide Synthesis
Longer peptides often require solid-phase synthesis using an Fmoc protection group strategy on an appropriate resin.  Dr. Reddy’s uses automated synthesizers and small-scale equipment for production of research-grade material and for toxicology studies. For production of material for small- and large-scale clinical trials, Dr. Reddy’s is equipped with solid-phase reactors with output up to multi kilo scale and corresponding cleavage systems. 

Liquid-phase Peptide Synthesis
Short- and medium-sized peptides often require a liquid-phase strategy in small- and large-scale equipment. Longer peptides can be produced by applying a fragment approach (Fmoc or BOC strategy) or using a combination of production of fragments on solid support and subsequent condensation of fragments in solution.  Oftentimes, this strategy reduces the number of purification steps providing material with very high purity and attractive economy.

Downstream Processing
Our labs are equipped with multiple HPLC units for the purification on reverse phase and in- process quality control. The large-scale formulation facilities offer fill and finish solution up to 100 kg.

Analytical Techniques
Dr. Reddy’s offers the following characterization of peptides: 

• LC and HR MS for mass and primary structures
• HPLC determination of assay and impurity profile
• characterization by NMR sequence analysis
• determination of heavy metals and counter ion
• characterization of enantiomeric purity
• determination of N-terminal
• secondary and tertiary structure and
• capillary-electrophoresis for mapping of poly saccharides

Quality and Regulatory Expertise
Dr. Reddy’s boasts the highest quality manufacturing, a strong regulatory track record including DMF/CMC section for customers, IND and NDA filing, and deep experience with regulatory authorities such as the US FDA and EMA.