Drug Development Services
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:
Our Drug / Chemical Development Services include
- Process Design and Development
- Process Optimization
- Route Scouting
- Polymorph Screening
- Scale-up Studies
- Material Generation and cGMP Manufacturing
We have Drug / Chemical Development Service Expertise in:
- Peptide
- HPAPIs (up to 0.1µg/m3)
- Carbohydrate
- Steroids
- Prostaglandins
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Pharmaceutical Analytical Services
Polymorph Screening
ADME/DMPK Services
Drug Formulation Services
In vivo Pharmacology
Medicinal Chemistry
Microbiology Testing
Peptide Synthesis
Development & Kilo Lab
Toxicology Studies
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Frequently asked questions
Which drug development services can Aurigene Pharmaceutical Services offer?
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.
What are the guidelines that APSL follows during drug substance development 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.
What resources will be available for your drug development program?
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.
What will be our team's accountability during your drug development projects?
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.
What is our approach to safety during development?
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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CPHI Worldwide 2023.
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