• search
Analytical Development and Manufacturing Services Analytical Development and Manufacturing Services

Analytical Development and Manufacturing Services

We offer fit-for-purpose analytical solutions.

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.

Speak to our experts

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

Virtual Tour

 
The importance of business continuity planning in CRDMO industry

NOVEMBER 16, 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...

Read More

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....

Read More

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. ...

Read More

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...

Read More

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. ...

Read More
View All
×

You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.

ProceedBack