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レディ博士のペプチドAPI製造

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.

Peptide Synthesis

Through various routes

Solid-phase Peptide Synthesis
  • Linear Synthesis
  • Fragment Synthesis
Solution Phase 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.

  • Peptide Synthesis

    Fully automated microwave-assisted solid-state peptide synthesis.

    1
  • Top-class Lyophilizers

    To prolong the shelf life (or) make the material more convenient for transport.

    2
  • Isolation of Peptides

    ANFD, reactors, and driers.

    3
  • A fully automated amino acid analyzer

    To ensure error-free derivatization.

    4
  • Applications of PAT (Gradient with NIR based)

    During development of chromatography and lyophilization.

    5
  • Peptide separation

    Chromatography systems of various grades.

    6
  • Purification and lyophilization

    Performed inside clean rooms at class 10,000.

    7
  • N-terminal sequencing & CD spectrophotometer

    To reveal peptides' sequence and structural alignment.

    8
  • For characterization of polymers

    Lab is equipped with a MALS detector with intrinsic viscometer online.

    9
  • Multi-faceted manufacturing facility

    Caters two products simultaneously with an output of up to Kg quantity of API.

    10

Let's connect

Got a query on our products? We’ll revert back at the earliest

弊社Eメールアドレス: api@drreddys.com | +91 40 49002222

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We support our API customers with APIs and Services for peptides with extensive peptide therapeutics development capabilities, state-of-the-art process facilities supported by formulation optimization platforms, and cGMP manufacturing capabilities.

Our expertise includes downstream purification, isolation techniques, impurity profiling, physicochemical and biological characterization.

We have proven capabilities in synthesizing complex peptides employing a solid-phase peptide synthesis or solution phase synthesis or hybrid approach utilizing the QbD framework.

We have adopted orthogonal purification and separation technologies for peptide purification.

We follow a complete state-of-the-art analytical API characterization to prove the sameness with the innovator products.

Proven regulatory track record including DMF, CMC, IND & NDA filing, and deep experience with regulatory authorities such as the USFDA & EMA.

All our manufacturing facilities are operated in accordance with cGMP regulations. And we can provide the cGMP-grade peptides.

We have appropriate in-process controls at various stages of peptide synthesis (KSMs, Intermediates, and Purification Stages).

Orthogonal analytical method development using complementary Stationary Phases, UHPLC, 2D Chromatographic Techniques, and Two-Dimensional Chromatography (2D).

We can scale up our capacity multi-folds to meet global market demands.
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