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Cell line generation Cell Bank characterization Product Characterization Lot Release Testing Bioassays In Vivo Safety studies Human PK/PD & Immunogenicity Consulting Services AURA biotechnologies Provides integrated Biosimilar support Snapshot on products and services

AURA Brochure

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Page 1: AURA Brochure

Cell line generation Cell Bank characterization

Product Characterization

Lot Release Testing

Bioassays In Vivo Safety studies

Human PK/PD & Immunogenicity

Consulting Services

AURA biotechnologies Provides integrated Biosimilar support

Snapshot on products and services

Page 2: AURA Brochure

Biopharma Kits & Reagents

AURA Biotechnologies Private Limited, Plot No. 6 & 7, Second floor, VGP Layout, PART II, Uthandi, ECR, Chennnai-600119, IndiaPh: (+91) -44-24531614-15; Email: [email protected]

Product Catalog #

Human PD ELISA Kits

Human TNF-α (High Sensitive ELISA) AB-PD-01

Human VEGF (High Sensitive ELISA kit) AB-PD-02

Immunogenicity Kits

MabThera (Rituximab) AB-IM-01

Filgrastim (G-CSF) AB-IM-02

Enbrel (Etanercept) AB-IM-03

Lucentis (Ranibizumab) AB-IM-04

Humira (Adalimumab) AB-IM-05

Teriparatide (PTH 1-34) AB-IM-06

Avastin (Bevacizumab) AB-IM-07

Product Catalog #

Residual analysis Kits

Protein A ELISA AB-IP-01

Human Serum Albumin AB-IP-02

Bovine Serum Albumin AB-IP-03

Human IgG ELISA AB-IP-04

Human IgM ELISA AB-IP-05

Transferrin ELISA AB-IP-05

Mycoplasma Testing Kit AB-IP-06

Host Cell protein (HCP)

E.Coli HCP ELISA AB-IP-07

CHO HCP ELISA AB-IP-08

Pichia pastoris AB-IP-09

Host Cell DNA

E. Coli HCD AB-IP-10

CHO HCD AB-IP-11

Pichia pastoris AB-IP-12

Product Method Catalog #

Human PK assays

Enbrel (Etanercept) ELISA AB-PK-01

Filgrastim (G-CSF) ELISA AB-PK-02

Teriparatide (PTH 1-34) ELISA AB-PK-03

MabThera (Rituximab) ELISA AB-PK-04

Avastin (Bevacizumab) ELISA AB-PK-05

Herceptin (Trastuzumab) ELISA AB-PK-06

Lucentis (Ranibizumab) ELISA AB-PK-07

Humira (Adalimumab) ELISA AB-PK-08

Remicade (Infliximab) ELISA AB-PK-09

Humira (Adalimumab) ELISA AB-PK-10

At AURA Biotech, we strive to enlighten life through Research. Our well-experienced R&D scientistswill make Biosimilar Research simpler for you to perform. The state-of-the-art infrastructure,combined with our knowledge in advanced technologies permit to deliver research products includingPK/PD ELISA and other kits at a reasonable price. Quality is our key asset and our passion for scienceincreases our flexibility to customize our products for your purpose. All kits are validated as perEMEA and ICH guideline.

Upcoming AssaysTocilizumab

&Denosumab

Page 3: AURA Brochure

Biopharma Services

AURA Biotechnologies Private Limited, Plot No. 6 & 7, Second floor, VGP Layout, PART II, Uthandi, ECR, Chennnai-600119, IndiaPh: (+91) -44-24531614-15; Email: [email protected]

Bioassay and Screening

Bio-potency assays

Proliferation & inhibition

Cytotoxicity

Neutralization Assays

Reporter gene expression

Cytokine and chemokine

Functional Assays

ADCC, ADCP & CDC assays

Immunogenicity assays development

Anti-Idiotypic antibody development

Ag-Ab Complex Specific antibodies

Antibody blocking/competitive antibody

Non- antigen blocking Antibody

Preclinical studies

Safety & Efficacy Studies

Human xenograft studies

Regulatory toxicology studies (GLP)

28 days TOX in rat for Biosimilar filing

Abnormal toxicity

Genetic Toxicology

Immunogenicity Pyrogen testing

Batch Release Testing

Identity Potency

Purity Impurities

Physicochemical properties

Presentation attributes

Sterility

Protein Characterization

Mass Spectrometry Analysis (MALDI TOF/TOF)

Peptide mapping Molecular Weight

UHPLC Analysis

Amino Acid Analysis Glycan Profiling

SEC, IEX, RP chromatography

Extinction Coefficient

Other analysis

Isoelectric Point Charge Profile

UV Spectrometry pH & Osmolality

SDS-PAGE Western Blot analysis

ADCP Assay for mAbs

We follow a rigorous quality analysis to

guarantee our product performance

Page 4: AURA Brochure

Antibodies and ELISA Kits

AURA Biotechnologies Private Limited, Plot No. 6 & 7, Second floor, VGP Layout, PART II, Uthandi, ECR, Chennnai-600119, IndiaPh: (+91) -44-24531614-15; Email: [email protected]

Product Catalog #

Human Diagnostic ELISA Kits

25OH Vitamin D (Total) AB-DE-01

Vitamin B12 AB-DE-02

Human TSH AB-DE-03

Human AMH AB-DE-04

Human IgE AB-DE-05

Research ELISA Kits

TNF- α AB-RE-01

IL- 1β AB-RE-02

IL- 6 AB-RE-03

IL- 10 AB-RE-04

Human IgG ELISA AB-RE-05

Product Catalog #

ELISA Reagents

3,3′,5,5′-Tetramethylbenzidine (TMB) Liquid Substrate

AB-ER-05

Streptavidin Coated plates

AB-ER-06

Recombinant Proteins (E. Coli)

Human TNF-α AB-RP-01

Bovine Enterokinase AB-RP-02

Human VEGF A165 AB-RP-03

Tev Protease AB-RP-04

Human EGF AB-RP-05

PTH (1-34) AB-RP-06

Native Protein Catalog #

HRP enzyme AB-ER-01

Streptavidin AB-ER-02

Streptavidin-HRPConjugate

AB-ER-03

Product Application Catalog #

Polyclonal (Secondary) Antibodies

Goat– Anti-Mouse-HRP I, IHC, E AB-PC-01

Goat- Anti–Mouse-ALP E AB-PC-02

Goat- Anti-Mouse-FITC F, IF AB-PC-03

Goat- Anti-Mouse-Biotin

E AB-PC-04

Goat- Anti-Mouse-PE F, IF AB-PC-05

Goat- Anti-Rabbit-HRP I, IHC, E AB-PC-06

Goat- Anti-Rabbit-ALP E AB-PC-07

Goat- Anti-Rabbit-FITC F, IF AB-PC-08

Goat- Anti-Rabbit-Biotin

E AB-PC-09

Goat- Anti-Rabbit-PE F, IF AB-PC-10

* Immuno Blotting (I), Immuno Hisctochemistry (IHC), ELISA (E), Flow Cytometry (F), Immuno Fluorescence (IF)

Page 5: AURA Brochure

Microbiology Testing

Sterility and Mycoplasma

Endotoxin & MAT

Host Cell Protein

Residual DNA Determination

AURA biotechnologies Supports your product batch testing and release requirements

Contact Us:

AURA Biotechnologies Private Limited,Plot No. 6 & 7, Second floor, VGP Layout, PART II, Uthandi, ECR, Chennnai-600119, IndiaPh: (+91) -44-24531614-15 Email: [email protected]; www.aurabiotech.com