Aurigene provides 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 and 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 teams to maximize the long-term sustainability of clones and proteins.
We enable development of stable and high yielding recombinant mammalian and microbial cell lines.
We have proven expertise in both mammalian and microbial cell line development for glycosylated and non-glycosylated proteins – antibodies, cytokines, fusion proteins etc.
The automation is done using ClonePix. cGMP cell bank creation and storage is done.
Our scale of operations spans from a few milliliters to 1000+ L in batch fed batch and perfusion cell culture platforms.
A high degree flexibility in using either stainless steel or single use bioreactor system. Rich technology transfer experience adds to such flexibility.
In-house expertise in analytical and process characterization capability enables for a one stop shop solution. Selection of the best clones, media and feeds under small-scale bioreactor conditions and scale-up using multi-parallel bioreactor.
Deep rooted in our fundamental understanding of protein chemistry, our formulation expertise spans a wide range of proteins such as – chemically derivatized proteins, receptor fusion proteins, hyper-glycosylated proteins and monoclonal antibodies and fragments.
Our approach to formulation development works with the flexibility needed for a wide variety of delivery systems – Vials, Pre-Filled Syringes, and Autoinjector Devices and can deliver stable DPs in either liquid or freeze-dried presentations.
Development is supported by a strong analytics platform through which stability and degradation profiles are evaluated and impurities are characterized.
Built on a solid platform of development and manufacturing scientists, we enable scale up for both upstream and downstream processes.
Rich technology transfer experience enables us to accept an existing process at any stage and scale the process up to over 1000 + Liter capacity.
Technological versatility in stainless steel, single use reactors and perfusion cell culture systems enables scale up technology choices. In-house expertise in analytical and process characterization capability enables for a one stop shop solution.
Multiple protein classes- Various IGgs, Fab, Cytokines
High-throughput instrumentation: ClonePix, Octet, CEDEX, Maxcyte, Ambr
One Stop Shop for everything – Process Development, Analytics and Characterization
Development supported by digital infrastructure
JUNE 28, 2022
Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...Read More
JANUARY 04, 2021
Building successful long-term partnerships with CDMOs from early drug discovery through commercialization 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 contr...Read More
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...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
An efficient approach for the synthesis of various imidazoquinoxalines and spiroquinoxalinones has been reported from 2-(1H-imidazol-1-yl) aniline and .. ...Read More
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