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Aurigene Pharmaceutical Services offers a wide range of drug development services / chemical development services for pharmaceutical, agrochemicals, fine chemicals and animal health industry. We support the development of Key Starting Materials (KSM) / Registered Starting Materials (RSM), advance intermediates and APIs from the pre-clinical to the commercial stage. Based on the requirement a systematic study is done to select the most efficient process based on Safety, Environment, and Legal, Economics, Control and Throughput (SELECT) principle. With a flexibility of handling milligram to metric tons scale requirements, our facilities can process normal small molecule chemistry to high potent molecules & APIs with an OEL down to 0.1µg/m3. Our process chemistry group is well supported by a broad range of services for analytical characterization. With a strong team of scientists and process engineers who are equipped with the latest processes and analytical instruments to support the continuous needs throughout the development journey.

Our Drug / Chemical Development Services include

  • Process Design and Development
  • Process Optimization
  • Route Scouting
  • Polymorph Screening
  • Scale-up Studies
  • Material Generation and cGMP Manufacturing

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We have Drug / Chemical Development Service Expertise in:

Aurigene Pharmaceutical Services is

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FAQ

We can provide end-to-end services along the entire drug development cycle from lead optimization to phase appropriate development meeting preclinical and phase I requirements. Route scouting, process development, optimization, analytical development, and engineering studies are part of this early development stage.

We provide detailed process optimization for late-phase programs using DoE (Design of Experiements) and process and analytical validations. An evolved QbD (Quality by Design) approach is used for late phase programs to minimize the risk of raw material quality, process, and analytical variations. This involves process control justification and spike-rejection studies as well.

Solid-state characterization, including salt screening, polymorph screening, and development, are offered phase-appropriate.

Our clients benefit from integrated services but can also choose standalone services.

We follow a phase-appropriate development for the early phase programs, ensuring economic development and meeting client requirements. The approach provides a faster, minimal development to enable and scale the process. The process safety and scalability will be evaluated at every stage of the development to perform a rapid scaleup and supply of drug substances. Our analytical development complements this service.

Our team of 150 scientific professionals consists of highly experienced chemists, engineers, and analysts engaged in drug substance development. The facilities include synthetic labs, process safety and engineering labs, and kilo labs. The focused tech transfer team will ensure seamless technology transfer from labs to GMP manufacturing facilities. Our technology platforms are HPAPIs, steroids, peptides, and PEGylation.

The development team comprises organic synthesis chemists, process development chemists, process engineers, analytical scientists, and tech transfer professionals. The team works in an integrated manner depending on the program requirements. Apart from the development activities, Aurigene Pharmaceutical Services has dedicated quality and regulatory teams to provide all the support during the development continuum. The program management ensures overall coordination and communication at every development phase.

The process safety approach covers potential hazard identification of raw materials, intermediates, reagents, and process conditions. The next step will be the evaluation and control through the process engineering team and developing a safe process. A safer operation on scale will be evaluated at every stage during the development.

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