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Development and Manufacturing Development and Manufacturing

Development and Manufacturing

High-quality and flexible scale development and manufacturing services for Biotherapeutics and Cell and Gene Therapy (CGT).

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.

Speak to our experts

mAb and Protein Therapeutics

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.

Plasmid

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.

Production scale:

  • Small-scale (0.1 to 1 mg)
  • Medium-scale (up to 10 mg)
  • Large-scale (100 mg to 1 g)

Analytical

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.

Fill Finish

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.

New facility under development for our biologics development and manufacturing capabilities

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.

Why Aurigene Pharmaceutical Services?

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

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