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mAb and Protein Therapeutics Development and Manufacturing Services mAb and Protein Therapeutics Development and Manufacturing Services

mAb and Protein Therapeutics Development and Manufacturing Services

We offer development and manufacturing services for antibody and protein therapeutics.

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.

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Cell Line Development

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.

Process Development

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.

Formulation Development

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.

Process Scale-up

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.

Why Aurigene Pharmaceutical Services?

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

Other Services

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Resources

Neoantigen Specific T cells For Cancer Immunotherapy

JUNE 28, 2022

Neoantigen Specific T cells For 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 bypass central thymic tolerance. The success of immune checkpoint blockade...

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Accelerating Drug Discovery Through Innovative Partnerships

Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....

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Custom Library Synthesis

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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog

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 ...

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Revisiting the reaction of b-chloroacroleins with 2-aminophenol: a new observation

2008

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 ...

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