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.
For Faster Execution of Engineering Batches
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.
Manufacturing Systems
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.
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Learning Resources
PROTACs: Research for a life without cancer
PROTACs:Proteolysis-targeting chimeras (PROTACs) are a rapidly evolving field with promising applications in cancer, neurodegenerative diseases, and other conditions where the regulation of protein levels is crucial.PROTACs are a novel class of small molecules designed to target specific proteins for degradation by the ubiquitin-proteasome system. This approach l...
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Advancement in personalized medicine and how the CRDMO industry is part of the solution
Personalized medicine is transforming the healthcare landscape by customizing treatment plans to individual patients’ unique genetic, clinical and environmental characteristics. These are effective and less invasive treatments for a wide range of conditions. Contract Research, Development and Manufacturing Organizations (CRDMOs) play an important role in enabli...
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Overcoming challenges with cyclic peptides for In-vitro experiments and Bioanalysis
Project Requirement:Cyclic peptides were to be analyzed for Kinetic solubility, Chrom Log D, MDCK, PAMPA, & Caco2 experiments, while overcoming the challenges associated with the impact of cyclization of peptides on in vitro experiments and bioanalysisWhat were the challenges!1. Nonspecific Binding (NSB)2. Precipitation of peptides while spiking DMSO stock to...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2024
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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Formulation Development and Characterization of ION and PH Dual Activated Nasal IN-SITU Gel Containing Levodopa and Carbidopa for the treatment of Parkinson’s Disease
Parkinson's disease is a chronic neurodegenerative disorder of the brain that results in involuntary or uncontrolled movements, including tremors, rigidity, and impaired balance and coordination. This condition is characterized by the depletion of melanin-containing neurons that are responsible for pigmentation in the midbrain....
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