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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:
Our Expertise in Handling Peptides:
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.
We are here to help, if you have any country specific requirements.
Technology used in Peptide Development:
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:
Peptide Synthesis:
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
- Linear Synthesis
- Fragment Synthesis
- Convergent Approach
Our Peptide Analytical Methodology:
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.
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1
Peptide Synthesis
Fully automated microwave-assisted solid-state peptide synthesis.
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2
Top-class Lyophilizers
To prolong the shelf life (or) make the material more convenient for transport.
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3
Isolation of Peptides
ANFD, reactors, and driers.
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4
A fully automated amino acid analyzer
To ensure error-free derivatization.
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5
Applications of PAT (Gradient with NIR based)
During development of chromatography and lyophilization.
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Peptide separation
Chromatography systems of various grades.
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7
Purification and lyophilization
Performed inside clean rooms at class 10,000.
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N-terminal sequencing & CD spectrophotometer
To reveal peptides' sequence and structural alignment.
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For characterization of polymers
Lab is equipped with a MALS detector with intrinsic viscometer online.
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Multi-faceted manufacturing facility
Caters two products simultaneously with an output of up to Kg quantity of API.
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本目錄中的任何信息（包括對任何產品或服務的任何引用）均不構成銷售要約，或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是，只要存在此類監管豁免，就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估，並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途，但可用於第 107A 節。
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