We have expertise and infrastructure for handling varied chemistry technologies and special platforms. We have been serving customers worldwide on various complex platforms like peptides, steroids, carbohydrates, mPEGs, and High Potent APIs (HPAPIs) for over two decades.
The various specialized chemistry development and manufacturing technologies we serve are:
Peptides
Peptides are one of the fastest-growing therapeutic modalities. We have extensive experience in peptide development and manufacturing. We can help develop various classes of peptides such as:
- Linear and branched chain peptides up to 40 AA
- Derivatives of peptides viz. steroids/ small molecules/ lipids/ carbohydrate/ PEG, depsipeptides, peptides with multiple disulfides bridges, and stapled peptides.
- We also have access to unnatural amino acid building blocks via asymmetric hydrogenation
Our advanced technology with modern infrastructure enables us to produce up to 2 kg of linear and branched chain peptides using solid, solution, and hybrid phase techniques. We provide peptide manufacturing services from our state-of-the-art manufacturing site in Vizag. This site is inspected by major regulatory bodies such as the US FDA, MHRA, PMDA, etc.
We have extensive expertise and infrastructure for downstream purification of peptides using RPHPLCs with PAT tools and fully automated ion chromatography. Also, we have Hastelloy ANFDs for the closed loop filtration process. We are also backed by a strong analytical team and advanced analytical instrumentation supporting impurity profiling and characterization.
Steroids
We have worked on Steroid APIs for more than 2 decades. As one of the leading contract research organizations, we have developed and manufactured many legacy steroid assets for our customers. Our experience ranges across various types of human and veterinary classes of steroids including glucocorticoids, hormonal steroids, fluorinated steroids, and derivatives of steroids such as peptides, small molecules, lipids, carbohydrates, and PEGs.
We have a US FDA-inspected dedicated steroid facility in Cuernavaca, Mexico. Our facility has multiple modules with a mix of SS, GL and HastelloyC reactors that can handle up to 300 kg batch.
mPEGs
With varied applications, mPEG derivatives are one of the most promising therapeutic options available. We provide end-to-end services in mPEG derivatives from synthetic route design to incorporating the activating group, as per customer’s requirements for commercial manufacturing of mPEG alcohols and mPEG derivatives.
We specialize in linear activated mPEG derivatives typically with a wide range of molecular weights from 2 kDa to 40 kDa. What makes us uniquely positioned in mPEGs is our technical and analytical know-how and ready access and backward integration of mPEG alcohol. We manufacture mPEG alcohol at our Mexico site and manufacture mPEG derivatives in Hyderabad and Mirfield sites. All our sites are USFDA and other reputed regulatory bodies inspected.
Carbohydrates
While carbohydrates have the potential to develop various therapeutic drugs, there is an inherent structural complexity to developing these molecules. We have a rich track record of having worked on all classes of carbohydrates such as:
- Monosaccharides
- Polysaccharides
- Iminosugars
- Carbocyclic sugars
- Nucleosides
- Locked Nucleic Acids (LNA)
- Glycopeptides
- Thioglycosides
We have capabilities across complex multi-step carbohydrates involving:
- Linear & convergent synthesis
- Selective protection and deprotection
- Control of selectivity in moisture-sensitive glycosylation
- Handling of triflates, azide transfer, and oxidations
We also have hands-on experience in the use of glycosyl donors such as SMethyl and STolyl and have capabilities in downstream purification and isolation involving
Carbohydrates are manufactured in Hyderabad CTO-2 and Vizag CTO-6 and CTO-SEZ sites. Our sites are equipped to handle carbohydrate manufacturing at scale with operations such as telescoping at commercial scale and various types of purification such as
- C-18 Purification (up to 2 Kg of crude compounds)
- Gel Permeation Chromatography (GPC) purification
- SAX (Strong Anion Exchange) purification
Our strength is our operational efficiency to remove chromatographic separation and use of simple techniques to limit impurities such as solubility and solvent-based extractions.
High Potent Small Molecule Development and Manufacturing Services
With the increasing prevalence of cancer, comes the need for more and more highly potent drugs. We offer highly potent small molecule development and manufacturing services for API and intermediates. The development lab is based out of Hyderabad and can handle molecules with OEL as low as 0.1 µg/m3 and with an output between 25 to 50 gms per batch.
We have one of the world’s largest capacities to manufacture highly potent compounds with OEL in the range of 0.1-1 μg/m³ (OEB 5). Our facilities are US FDA and other reputed regulatory agencies audited. We have the capability of handling high potent compounds, backed by special unit operations such as micronization and spray drying procedures. Our facility is designed to give output as low as 500 gm to multi-tons.
Why Aurigene Pharmaceutical Services?
More than 2 decades of experience
US FDA-inspected labs and 8 US FDA inspected cGMP facilities
Analytical talent and infrastructure
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Hyderabad R and D Center
Bangalore R and D Center
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Resources
JUNE 28, 2022
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