Dr. Reddy’s has complete peptide API therapeutics development capability with state-of-the-art process facilities, supported by formulation optimization platform and cGMP quality system. We have deep scientific acumen in understanding solid, solution, and hybrid synthetic approaches governed by QbD. Our expertise also includes downstream purification, isolation techniques, peptide synthesis service, impurity profiling, physicochemical and biological characterization.
Peptide Production - With competent technical and cross-functional team comprising of Scientists, analysts, and engineers we can quickly scale up and synthesize various peptides ranging from few grams to multi-kilogram levels.
Portfolio of the peptide APIs includes:
Collaborative & cross functional expertise: R&D, Purification, Engineering & Analytical.
A 360o quality management system - To ensure peptide products' conformity and underline standard operation processes.
A suitable control strategy by the QBD approach is in place to scale up multi-fold peptide APIs to meet the global demands.
Proven skills in synthesizing complex peptide APIs with strategic approaches.
Expertise in peptide characterization of complex peptides using orthogonal characterization techniques.
Evaluation of solutions for purification using crystallization techniques to enable batch manufacturing at higher scale.
Different purification approaches to meet RLD quality.
Effective process development with high quality to meet regulatory requirements.
Dr. Reddy’s practices a proprietary technology for rapid synthesis of peptides developed at its R&D site in Cambridge (UK) in close collaboration with its central R&D team based out of Innovation Plaza, Hyderabad (India). The process is seamlessly transferred to our manufacturing site in India.
The various steps involved in the peptide API manufacturing are as follows:
Dr. Reddy's has developed and established a complete quality management system to ensure the conformity of peptide products and to maintain the underline standard operation processes, including peptide production, raw material controls, synthesis, purification, quality control, packaging, shipping, and customer complaints. In addition, we have strategic approaches in place to synthesize complex peptides.
Through various routes
We follow a complete analytical characterization process to establish sameness of the peptide API with innovators as per regulatory guidelines. In addition to the regular HPLC and UPLC systems, our analytical peptide lab is equipped with highly specialized equipment to characterize and synthesize peptide APIs.
Our extensive range of purification technologies includes a full-fledged purification facility equipped with automated chromatography systems, ion exchange, gel filtration, high-pressure reverse phase chromatography, membrane filtration process, and lyophilization techniques.
Fully automated microwave-assisted solid-state peptide synthesis.
To prolong the shelf life (or) make the material more convenient for transport.
ANFD, reactors, and driers.
To ensure error-free derivatization.
During development of chromatography and lyophilization.
Chromatography systems of various grades.
Performed inside clean rooms at class 10,000.
To reveal peptides' sequence and structural alignment.
Lab is equipped with a MALS detector with intrinsic viscometer online.
Caters two products simultaneously with an output of up to Kg quantity of API.
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