Aurigene Pharmaceutical Services is rapidly positioning itself to provide end-to-end integrated development and manufacturing offerings in traditional and advanced drug modalities. Our mAb and protein therapeutics development is supported by in-house physiochemical and bio analytical development. We have a state-of-the-art cGMP viral vector manufacturing facility being commissioned.
Our manufacturing services cater to both GMP and non-GMP manufacturing for preclinical development as well as GMP operations to support clinical or commercial needs for any recombinant protein expressed in suspension mammalian culture or E.coli.
We have technological flexibility in both stainless steel and single-use bioreactor systems, as well as ability to undertake alternating tangential flow for commercial scale manufacturing.
We undertake an integrated approach to our quality management system that enables greater flexibility and leverage pan – organization experience in managing regulatory audits.
We provide comprehensive capabilities for mAb and protein therapeutics development. It is supported by in-house physiochemical and bio analytical development. Our strength is built on a deep understanding of cell culture, protein chemistry and an integrated analytics platform enabling a robust, scalable, controlled process.
Our approach to mAb and protein therapeutics development is based on a balance of ‘Productivity, Quality and Stability’. This approach is enabled by a collaboration between the molecular biology and the analytical teams to maximize the long-term sustainability of clones and proteins.
Aurigene Pharmaceutical Services provide Plasmid DNA production service. We provide both Research grade and GMP ready plasmids.
Research grade plasmids are used for in vitro applications in cloning, mutagenesis, microbial transformation and protein production. GMP ready plasmids are used in IVT mRNA, protein and mAb production, stable cell line generation, bacmid generation, viral packaging, vaccine, gene therapy studies and animal immunization.
Analytical services are used to identify, isolate or quantify molecules and to characterize their physical properties. Aurigene provides physiochemical and biological characterization services.
Backed by our strong protein chemistry background, we enable ‘Finger-Print’ protein structure and functional characterization for proteins from naked proteins to hyper-glycosylated or derivatized proteins.
Our biological characterization capability enables a sound understanding of the biological mechanism of action of the product. We can support a wide variety of biological assays including, cell-proliferation/killing, binding affinity, cell signaling and viability or endpoint assays using both transformed cell lines and primary cells.
With over 10,000 Sq.m of Fill Finish footprint, we can support filling of a wide range of presentations – Vials (Liquid and Lyophilized), Pre-filled Syringes and Autoinjectors.
Automation equipped; our filling capability addresses – High Accuracy – High Concentration – High Viscosity – Low Volume – protein filling. End-to-end single use capability enables for faster change over and assurance of cleaning validation.
Our integrated approach to quality management systems enables greater flexibility and leverage pan -organization experience in managing regulatory audits.
We are expanding our integrated biologics development and manufacturing capabilities. We are establishing this facility with a first of many investments of 40 million USD.
This new state-of-the art facility will cater us to offer integrated, accelerated and efficient solutions for clinical development and supply. The new facility is based on a state-of-the-art design concept, allowing maximum flexibility for a multi-product, multi-platform offering across proteins, mAbs, and viral vectors.
A dedicated team with over 20 years of experience, including in commercializing 6 Biologic drugs enable us to help accelerate your projects with this new investment in ready-to-access, modular, multi-product facility for early phase development and access to large scale and multiple- regulatory body audited GMP manufacturing facility for commercial manufacturing.
High quality and flexible scale production
One Stop Solution
Development supported by digital infrastructure
Integrated approach to safety and quality management systems
Integrated QC testing and release
Diverse platform of instruments and technologies
In-house capability across the value chain with a trained scientific staff
APRIL 24, 2023
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...Read More
Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contract development and manufacturing organizations (CDMOs) for collaborations as they seek more adaptable capacity and cheaper...Read More
Aurigene Pharmaceutical Services off end-to-end formulation development and manufacturing services fm pr-formulations, clinical development, clinical supplies to commercial manufacturing. ...Read More
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...Read More
The reaction of b-chloroacrolein with 1 equiv of 2-aminophenol in DMF proceeds smoothly to afford 11-hydroxy derivative of chromenoquinoline in good yield. This single pot method allows for a rapid access to a variety of chromenoquinolines or oxepinoquinolines depending on the nature of b-chloroacrolein used. The structures were established by spectroscopic data ...Read More
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...Read More
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...Read More
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...Read More
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