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Integrated Drug Substance and Drug Product (DS-DP)

Integrated Drug Substance and Drug Product (DS-DP)

Hassle-free one-stop shop for accelerating your drug discovery journey.

Experience and expertise are key to successful new drug development. There are various stages to a drug development program that need alignment of objectives and optimization of resource utilization. While the clinical success or failure of a drug is majorly influenced by its therapeutic potential, how systematically it is developed has an equal contribution to its success.

By integrating the development and manufacturing of drug substance and formulations, we are uniquely positioned to offer a significant advantage to customers that leverage the technical integration of both teams.

Speak to our experts

The End-to-end Integration Benefits

  • Continuous feedback-loop for a better quality of development between API and formulation teams
  • Co-located teams share & leverage knowledge at each stage of product development and manufacturing
  • Cost of common procurement such as analytical columns as reagents, logistics, and repeat analysis are minimized
  • Parallel activities are better aligned benefiting project timelines
  • Benefits of uniform quality systems at R and D and manufacturing

Why Aurigene Pharmaceutical Services?

20+ years legacy of providing integrated API and formulation services

Fit-for-purpose development strategy

Co-located cross-functional teams

Services across the product lifecycle

US FDA-inspected GMP facilities

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JUNE 28, 2022

Neoantigen Specific T cells For Cancer Immunotherapy

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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

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Technology meets sustainability - How a complex API development process goes green

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Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

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