Peptide Innovation LP Peptide Innovation LP

Empowering Peptide Innovation

with

Our end-to end CRDMO capabilities

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25+ Years of
Expertise

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19 NCEs
commercialized

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16 USFDA approved
cGMP facilities

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Our peptide capabilities


Other specialized Chemistry CDMO technologies we offer

Write this in five lines. We have 15+ years of experience with Methoxy Polyethylene Glycol (mPEG) and activated mPEG development and manufacturing. We perform mPEG development at our R and D center in Hyderabad. Our team has extensive experience in synthesis, analysis, purification and troubleshooting of mPEG derivatives and have technical capabilities in synthetic route design to incorporate various activating groups and help customize products as per end applications.

mPEGs manufacturing

Aurigene is a leading manufacturer and supplier of Methoxy Polyethylene Glycol (mPEGs) and activated Methoxy Polyethylene Glycol (mPEGs) which are used for the conjugation of proteins, antibody fragments and peptides. With our GMP manufacturing capabilities and backward integration to highly pure Methoxy PEG-OH, we guarantee the quality and security of the supplies of our activated Methoxy PEGs (mPEGs) products. As a leading CDMO, we understand customer requirements and customize our products to meet the client’s requirements. Currently, we serve multiple customers in various products such as diagnostic players, other mPEG suppliers, and big pharma using mPEG for advanced therapeutics. In addition, our backward integration of key raw materials makes it possible to ensure a sustainable quality of the final activated mPEG throughout the manufacturing process. We have technical capabilities in synthetic route design to incorporate the activating group and help customize products as per end applications. Our centers at Hyderabad and Mirfield are equipped with advanced instruments to enable the scale-up of activated mPEG production up to 90 kg per batch. Successful custom PEGylation requires several factors to be optimized such as the site of PEGylation, chain length, and mPEG linkers. Determining the optimum mPEG may require the testing of several activated mPEGs at different chain lengths. We offer a range of activated linear mPEGs to enable our customers to find the ideal mPEG for conjugation of the required quality, with high levels of activation, narrow polydispersity and low diol content.

Aurigene has two decades of experience in the development and manufacturing of steroids. From concept to launch, we can safely handle the development and scale-up of steroids in India and manufacture commercial quantities at our dedicated cGMP manufacturing facility in Mexico. Our development and manufacturing services for steroids are supported by the dedicated facility with high end infrastructure.

We have one of the largest capacities in the world to manufacture highly potent compounds with Occupational Exposure Limit (OEL) in the range of 0.1-1 μg/m 3 (OEB 5). Our facilities are audited by US FDA and regulatory bodies.
We offer manufacturing of high potent compounds supported by special unit operations like micronization and spray drying. Our facility is designed to give output as low as 100 gm to multi-tons.

While carbohydrates have the potential to develop various therapeutic drugs, there is an inherent structural complexity in developing these molecules. At Aurigene, 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, and Thioglycosides. We have capabilities across complex multi-step carbohydrates involving linear and convergent synthesis,

carbohydrate manufacturing

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 like SMethyl and STolyl and have capabilities in downstream purification and isolation involving water-soluble intermediates.

The Aurigene expertise

Aurigene Pharmaceutical Services offers a wide array of manufacturing services to biotechnology, pharmaceutical, agrochemical and specialty chemical firms. We provide clinical and commercial supplies of APIs through our 16 US FDA-inspected cGMP manufacturing sites across India, UK and Mexico. We operate thousands of kilo liters of reactor volumes with thousand-plus reactors in intermediate blocks and clean rooms out of which hundreds of reactors can cater to special technologies like High Potent APIs, Peptides, Steroids and Prostaglandins. All our plants are operated by cGMP and regularly inspected/audited by international authorities and customers.

We offer manufacturing services in wide range of scales and are expanding our capabilities while maintaining high safety standards. Our facilities are operated with sustainability as one of the focus areas with principles around

video
Aurigene Pharmaceutical Services Limited is a leading contract research, development and manufacturing organization (CDMO) providing end-to-end solutions. Corporate Video | CDMO - Aurigene Pharmaceutical Services /sites/default/files/2021-04/Corporate%20Video%20_%20CDMO%20_%20Aurigene%20Pharmaceutical%20Services_1_.mp4

environmental and social governance intact. Operations of our sites are linked with processes around: Green Chemistry, waste minimization, waste management, water neutrality, emission control, reducing carbon footprint and usage of renewable power, people practice, community development activities, and a strong focus on ethics compliance and transparency.

25+

Years of
Expertise

  • 400+ projects from more than 100 global customers
  • 700+ dedicated scientists
  • End-to-end regulatory support
16

USFDA approved
cGMP facilities

India | UK | Mexico

  • 4100+ m 3 capacity
  • 1250+ reactors, including 100+ reactors with containment facility
  • 5000+ MT of intermediaries manufactured per annum
  • 2100+ MT of APIs manufactured per annum
19

NCEs
commercialized

  • 15+ dedicated labs for process development along with analytical center of excellence
  • Dedicated production blocks for peptides, continuous manufacturing, steroids, and PEG alcohol and derivatives
  • Cryogenic reaction, High Potent and High-pressure reaction capabilities

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.

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