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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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