We provide physiochemical characterization services ranging from protein structure confirmation to amino acid content detection. We also quantify free cysteines and detect product impurities such as glycation and deamidation.
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 or killing, binding affinity, cell signaling, and viability or endpoint assays using both transformed cell lines and primary cells.
Physiochemical Characterization
We provide physiochemical characterization services ranging from protein structure confirmation to amino acid content detection. We also quantify free cysteines and detect product impurities such as glycation and deamidation.
The ability is based on a diverse platform of instruments and technologies supported by a fully-trained technical staff:
- 21 CFR part 11 and GAMP compliant system-based labs
- Comprehensive infrastructure to support orthogonal confirmation of product parameters
- Experience across diverse protein expression systems
Catalog:
- Primary structure: Intact mass and fragmented mass
- Higher order structure: secondary and tertiary structure, melting point, disulfide linkage and free thiol
- Post-translational modification: oligosaccharide profiling, oxidation, deamidation and cleavage
- Product/process - related impurities: size and charge variant analysis
- Technology: Mass spectrometry, HPLC, UPLC, spectroscopy, circular dichroism, fluorometry, DSC DLS, SEC MALS, ion chromatography, CEIEF, CESDS and solo VpE
- Protein: mAb, Fab, fusion protein, cytokine, enzyme, hormone, hyperglycosylated proteins and derivatized proteins
Biological Characterization
Our capability in luminescence and fluorescence-based assays and flow cytometry enables a wider reach of biological characterization. In addition, we also develop bio-assays for clinical sample analysis and immunogenicity assessment:
- Development of bioassays and cell-based assay employing primary and derived cell lines
- Expertise in luminescence, fluorescence and flow cytometry-based assay
- Wide variety of cell signaling and endpoint assays – ADCC, CDC and proliferation
- Ability to handle clinical samples
Catalog:
- Signaling: GPCR, calcium release, kinase and phosphorylation
- Binding: Direct/indirect ELISA, competition ELISA and surface plasmon resonance (BIAcore)
- Viability: ADCC, CDC and proliferation
- PK/PD: Serum drug concentration, immunogenicity and neutralizing antibody
- Technology: Luminescence and fluorescence-based methods, multicolor flow cytometry, microscopy and primary cell culture
- Protein: mAb, Fab, fusion protein, cytokine, enzyme, hormone, hyperglycosylated proteins and derivatized proteins
Why Aurigene Pharmaceutical Services?
ALCOA+ driven quality systems
Diverse platform of instruments and technologies
Integrated approach to safety and quality management systems
In-house capability across the value chain with a trained scientific staff
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Hyderabad R and D Center
Bangalore R and D Center
Resources
APRIL 24, 2023
The importance of business continuity planning in CRDMO industry
Both natural and unnatural catastrophic events inflict negative consequences due to the ever-increasing interconnectedness of the global economy. Those consequences are certain to last for longer duration. e.g.; The Covid-19 pandemic is still having a negative impact on the global economy. Maintaining continuity is critical for all businesses, but perhaps no othe...
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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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Physiochemical Characterization Services
Backed by our strong chemistry, we enable “Finger-print” protein structure and functional characterization for proteins from naked proteins to hyperglycosylated or derivatized proteins. ...
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Expediting early development through innovative precision capsule filling technology
Introduction: Any new chemical entity (NCE) needs to undergo various stages of development such as preclinical and clinical trials before drug product is approved by regulatory agencies and available for patient. Formulations developed during early phases are simple formulations to enable phase appropriate studies like screening, dose ranging, toxicological and d...
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Construction of a six-membered fused N-heterocyclic ring via a new 3-component reaction: synthesis of (pyrazolo)pyrimidines/pyridinesw
2012
A conceptually new three-component reaction was developed to construct a six-membered fused N-heterocyclic ring affording (pyrazolo)pyrimidines/pyridines as potential inhibitors of PDE4. The reaction is catalyzed by triflic acid in acetic acid in the presence of aerial oxygen. ...
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Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2005
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2005
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
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Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2005
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
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