Discovery Biology Services
Integrated
services
Co-located
teams
20+ years
of legacy
Target identification
to IND filing
Our small molecule discovery services offerings
Customized and innovative solutions for standalone DMPK and integrated drug discovery services with quick turnaround times
- Seasoned in integrated drug discovery services
- Associated with +60 integrated drug discovery programs.
- Quality and reproducible data with quick turnaround times.
- GLP accredited bioanalytical facility has supported +200 GLP studies.
In vitro adme | In vitro pharmacokinetics | GLP and Non-GLP Bioanalysis
focused on running standard and highly specialized biochemical and cell based assays and providing expertise to support stand alone or integrated drug discovery programs.
- World-class scientists developed and validated over several unique assays
- In-depth knowledge of different therapeutic areas and target classes
- experience in target classes like GPCRs, ion channels, proteases, other hydrolytic enzymes, membrane receptors etc.
In vitro assay Development | In vitro assay Capability Range
Wide array of therapeutic areas and target specific models
- CPCSEA approved and AAALAC accredited Vivarium.
- Over 1000 efficacy studies in multiple Therapy areas.
- Study data submissions to USFDA, DCGI. Microbiology
- BSL-2 compliant lab and a dedicated in-vivo facility.
- Successfully audited by the US FDA in 2019
Oncology | Inflammation and auto-immune disorders | Pain | Metabolic disorders
Offering full range of exploratory and GLP toxicology studies for 20+ years
- Experienced and qualified scientists with DABTs and DIBTP certified pathologists.
- Track record of successfully filing IND’s with the US FDA, MHRA, EMA and DCGI and ANDAs with US FDA.
- Toxicology labs spread over 18,040 square feet.
Preclinical safety assessment | Genetic toxicology | Animal toxicology
Capabilities for anti-bacterial and anti-fungal in vitro assays along with murine infection models
- Pharmaceutical microbiology testing is supported by BSL-2 compliant lab and a dedicated in vivo facility for bacterial and fungal infection murine disease models.
- Our team has collaborated on numerous anti-bacterial and anti-fungal agent discovery projects with innovator pharma companies.
- Dedicated team of scientists and allied staff with vast experience in anti-infective drug discovery projects.
Integrated Drug Discovery | BSL-2 compliant facility | US FDA audited
Why Aurigene CRDMO services?
25+ years of expertise & quality track record
- Commercialized 6 products in 30+ countries
- 200+ scientists
- Accredited & certified facilities - USA FDA, EMA inspected CGMP facility, & AAALAC accredited vivarium
State-of-the art facilities
- Pilot/clinical scale facility for CGMP & non-GMP supplies (200L reactors)
- Large scale commercial CGMP Drug Substance facility with single use bioreactors with capacity of ~25,000 L
- CGMP Drug Product filling vials, pre-filled syringes and cartridge or device for liquid and lyophilized formulations
Our Infrastructure
R and D centers
Aurigene Pharmaceutical Services is well-equipped with laboratories from discovery to clinical phase III for NCEs and NBEs. We operate two state-of-the-art R and D centers in Bangalore and Hyderabad. Our R and D centers are equipped with 60+ modular laboratories to handle highly potent substances, peptides, oligonucleotides etc. Our facility also has an extensive analytical center of excellence in addition to special purpose labs for safety assessment studies and polymorphism studies. Our best-in-class discovery biology services are supported by AAALAC accredited vivarium, BSL-2 compliant labs, in vivo facilities, GLP and other regulatory bodies accredited toxicology labs. Our state-of-the-art preclinical evaluation safety facility has been inspected by FCPSA Netherlands, DCGI and is annually inspected by National GLP Compliance Monitoring Authority (NGCMA). Our facility has also been inspected by the US FDA and the quality systems in this facility are in accordance with NGCMA and US FDA standards.
Manufacturing facilities
We have access to cGMP manufacturing facilities in the UK, Mexico and India. We operate thousands of kilo liters of API capacities that can handle various range of chemistries from regular small molecules, peptides, potent compounds, steroids, carbohydrates and pegylated drugs. In addition, we also operate formulation manufacturing plants that can handle various dosage forms including oral solids, parenteral and topical. Our facilities are designed modularly and offer flexibility of scale, enabling efficient operations. Our manufacturing facilities are regularly inspected by regulatory agencies.
ESG/Sustainability
Aurigene as a wholly owned subsidiary of Dr. Reddy’s Laboratories adopts the ESG goals of our parent company. Dr.Reddy’s has been committed to sustainability, diversity and equality for over two decades and has been honored with numerous accreditations and awards.
Awarded ‘Gold Medal’ status by EcoVadis, the global sustainability ratings agency, 2023
First Indian pharma firm to earn a place in the Standard & Poor Dow Jones Sustainability World Index (DJSI World) for 2023.
6th year in a row to be featured in the Bloomberg Gender-Equality Index (GEI) 2023.
Achieved “A” rating for supplier engagement, and for climate change & water security in 2023 by Carbon Disclosure Project (CDP)
The Aurigene expertise
Aurigene Pharmaceutical Services Ltd. is an internationally acclaimed contract research, development and manufacturing organization (CDMO) offering integrated solutions to pharmaceutical companies. We combine knowledge and experience with cutting-edge technology to help our clients accelerate their products from lab to market.
Our end-to-end services ranging from discovery chemistry, discovery biology, custom development, manufacturing of clinical compounds and commercial contract manufacturing have been successfully fulfilling the outsourcing needs of pioneering pharma companies for decades. Our world-class R&D centers in India with 650+ scientists are supported by state-of-the-art commercial manufacturing facilities in India, the UK, Mexico and the United States.
Explore how we accelerate small molecules' journey from target
to candidate with end-to-end discovery services.
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