At Aurigene Pharmaceutical Services, manufacturing of both Drug Substance (DS) and Drug Product (DP) are done on site. Clinical and commercial manufacturing of DS is done at 200L and 1000L scale with the ability to manufacture in stainless steel as well as single use technology. Integrated fill finish line can package the product in vials, PFS and cartridges.
The manufacturing is supported by in house physiochemical and bio analytical development. The development and manufacturing is supported with utility blocks, warehouse spaces and R and D labs. We are well equipped with WHO-GMP qualified plants. We have GMP approvals from various leading agencies including PIC/S authorities. Our facility is well equipped with state-of-the-art facilities and high throughput instrumentations like ClonePix, Octet, CEDEX, Maxcyte, Ambr etc.
We have Non-GMP manufacturing capability in the range of 50L – 200L and GMP manufacturing capability over a wide scale - 50L to 2,000L in single use bioreactors. We offer technological flexibility – Batch, Fed Batch, Perfusion in single use or stainless-steel reactors.
We provide Integrated approach to Safety and Quality management systems, leveraging a pan- organizational experience.
Aurigene is one stop shop across the product fife cycle – proof of concept to commercial. We can support large scale vaccine manufacturing – 2x1KL per batch run in single use platform.
We are committed to data integrity and reliability based on digital data recording in accordance with GAMP 5 requirements. We follow documentation and report writing to comply with regulatory filing with FDA, PMDA and EMEA. Our development is supported by digital infrastructure.
SEPTEMBER 04, 2023
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