Affigenix Biosolutions Pvt Ltd is an emerging life science company in the CREW Group that provides customized Immunoassay Biochemistry Reagents, diagnostic kits and other biosolutions to Biopharma, Biotech, Food and Agriculture companies. Affigenix also focuses on developing therapeutic and diagnostic products to metabolic, autoimmune, oncology and targeted tropical diseases.
Biotechnology Services
Recombinant protein producing Host cell characterization
- Mammalian cells-CHO
- Yeast- Pichia and Saccharomyces
- Bacteria- E.coli
- Fungus- Aspergillus
- (Plant- Tobacco)
Bioprocess Development – Process and product (DS & DP) impurity clearance assays
- Protein A / G
- Enzymes- Trypsin, Chymotrypsin
- Carboxypeptidase. Enterokinase
- Inhibitors- Peptide Enzyme Inhibitors
- Proteins-Albumin
- HCP & HC-DNA
Bioassay and Bioanalytical assays
- Bioassay Service
ADCC, CDC and metabolic assays, cell proliferation and cell survival.
- Immunoassay development/qualification
Specific, sensitive serum based-PK, Immunogenicity (3 tier approach- ADA screening, confirmatory, and Titer), Commercial kit optimization, antibody pairing.
- Cell based and non-cell based Nab assay development
Functional enzyme inhibitor based non-cell-based assay and radio labeled and unlabeled functional metabolic assay.
Niche Assay
- Pentason Polysulphate
- Glatiramer acetate
- Sucralphate
- Liraglutide
- Trypsin
- Carboxy Peptidase
- Protein A
- Aspiraginase/PEG-aspiraginase
Biomarker Discovery Drug Repositioning / Repurposing
Pharmaceutical Microbiology Testing
- Bacterial Endotoxin (LAL) Testing
- Bioburden analysis
- Microbial identification
- Preservative Efficacy Testing
- Microbiological antibiotic assay
- Environmental Monitoring Services
Bio Manufacturing Support
- Multiplexed and Singleplex Immunoassays
- Potency assays
- Chromatographic assays
- Titrimetric assays
- Bioburden analysis
- Microbiological screening
NABL Accredited Services
- Batch release testing
Visual observation (USP), color, label claim, packaging, pH, osmolality, endotoxin, volume in syringes and vials, isoform analysis, purity, identity, sterility, antibody binding, UV280 protein quantification, residual HCP, residual host DNA, residual protein A, residual enzyme, In vivo pyrogen test, monocyte activation test, reporter gene bioassay and stability testing.
- Cell line characterization
Identity/Purity, viability, doubling time, isoenzyme analysis, gene copy number determination, receptor density, restriction map analysis, DNA RNA finger printing, karyotyping, ploidy screening, mycoplasma testing (cultivable and non-cultivable strains or by PCR), bacteriostasis and fungistasis, sterility.
- HCP and anti- HCP antibody characterization
Antibody isotype, anti-HCP antibody and HCP antigen characterization using 1D, 2D western.
Diagnostic Kit Development and Manufacturing Services
- Antigen expression and purification
- Antibody development (pAb and Mab)
- ELISA pre-coating
- Antigen and antibody labeling .conjugation-Biotin, Ruthenium, ALP,HRP
- Bulk manufacturing of IVD kits under loan license
- Design and development of molecular diagnostics
- Bulk manufacturing of critical reagents
- Customized IVD kit developments
BIOPHARMA PRODUCTS
Customized immunoassay Biochemistry Reagents for PK assays for Hormones and others
| Drugs | Critical reagents | Pharmacokinetic / Toxicokinetic assay format a,b |
| Hormones and others | suitable for assays | Colorimetric / Chemiluminescence |
| Erythropoetin (Epoetin alpha) | Anti Drug Antibodies, Identity | Sandwich ELISA |
| Darbepoetin (Epo) | Anti Drug Antibodies, Identity | Sandwich ELISA |
| GCSF (Filgrastim) | Anti Drug Antibodies, Identity | Sandwich ELISA |
| PEG GCSF ( PEG filgrastim) | Anti Drug Antibodies, Identity | Sandwich ELISA |
| rPTH | Anti Drug Antibodies, Identity | Enquire |
| Interferon beta- 1a (Avonex/Rebif) | Enquire | Enquire |
| Follicle stimulating hormone (FSH) | Enquire | Enquire |
| Insulin | Anti Drug Antibodies, Identity | Enquire |
| Glargine | Analogue specific Anti Drug Antibodies | Enquire |
| Lispro | Analogue specific Anti Drug Antibodies | Enquire |
| Aspart | Analogue specific Anti Drug Antibodies | Enquire |
| PolyPeptide | ||
| Copaxone(Glatiramer acetate ) | Anti Drug Antibodies, Identity | Enquire |
Customized immunoassay Biochemistry Reagents for PK assays for therapeutic Mabs and Fusion proteins
| Therapeutic Mab’s | Critical reagents | Pharmacokinetic / Toxicokinetic assay format |
| suitable for assays | ||
| Humira ( Adalimumab) | Anti Drug Antibodies & anti-Idiotypic Ab | Ligand Binding Assay |
| Herceptin(Trastuzumab) | Anti Drug Antibodies & anti-Idiotypic Ab | Sandwich ELISA |
| Remicade (Infliximab) | Enquire | Ligand Binding Assay |
| Rituxan ( Rituximab) | Enquire | Sandwich ELISA |
| Avastin (Bevacizumab) | Anti Drug Antibodies | Sandwich ELISA |
| Enbrel( Etanercept ) | and anti-TNF A | Ligand Binding Assay |
| Lucentis (Ranibizumab) | Anti Drug Antibodies | Sandwich ELISA |
Customized immunoassay Biochemistry Reagents for Immunogenicity assays for Hormones and others
| Drugs | Critical reagents | Anti Drug Antibody assay format |
| Hormones and others | suitable for assays | |
| Erythropoetin (Epoetin alpha) | ADA, Identity, Neutralizing Ab | AD & Bridge ELISA |
| Darbepoetin (Epo) | ADA, Identity, Neutralizing Ab | AD & Bridge ELISA |
| GCSF (Filgrastim) | ADA, Identity, Neutralizing Ab | AD & Bridge ELISA |
| PEG GCSF ( PEG filgrastim) | ADA, Identity, Neutralizing Ab | AD & Bridge ELISA |
| rPTH | ADA, Identity, Neutralizing Ab | AD & Bridge/ Competetive ELISA |
| Interferon beta- 1a (Avonex/Rebif) | Enquire | Enquire |
| Follicle stimulating hormone (FSH) | Enquire | Enquire |
| Insulin | ADA, Identity, Neutralizing Ab | Enquire |
| Glargine | Analogue specific ADA | Enquire |
| Lispro | Analogue specific ADA | Enquire |
| Aspart | Analogue specific ADA | Enquire |
| PolyPeptide | ||
| Copaxone(Glatiramer acetate ) | ADA | Enquire |
Customized immunoassay Reagents for immunogenicity assays for therapeutic Mabs and Fusion Proteins
| Drugs | Critical reagents | ADA assay format a,b |
| Hormones and others | suitable for assays | |
| Humira (Adalimumab) | ADA and anti-ID for Nab | Acid dissociation & Bridge ELISA |
| Herceptin(Trastuzumab) | ADA and anti-ID for Nab | Acid dissociation & Bridge ELISA |
| Remicade (Infliximab) | Enquire | Acid dissociation & Bridge ELISA |
| Rituxan ( Rituximab) | Enquire | Acid dissociation & Bridge ELISA |
| Avastin (Bevacizumab) | ADA | Acid dissociation & Bridge ELISA |
| Enbrel( Etanercept ) | ADA and anti-TNF A | Acid dissociation & Bridge ELISA |
| Lucentis (Ranibizumab) | ADA | Acid dissociation & Bridge ELISA |
Customized Immunoassay Reagents for In-Process/ Leached/ Co-purified Product Impurity Detection
| Impurity clearance assays | Qualitative | Quantitative | Clinical study requirement * | |
| Impurity | Characterization service | Assay format a,b | Assay type | Assay format a,b |
| HCP: Host cell protein(CHO & E.coli ) | 1D/2D , 1D 2D WB, a,b | Sandwich ELISA | Anti HCP antibody assay | Acid dissociation & Bridge ELISA |
| HC DNA: Host cell DNA | DNA std quantification | Q-PCR | – | – |
| Leached Protein A | 1D/2D , 1D 2D WB, a,b | Sandwich ELISA | Anti Protein A antibody assay | Acid dissociation & Bridge ELISA |
| Residual carboxypeptidase | 1D/2D , 1D 2D WB, a,b | Sandwich ELISA | Anti CbP antibody assay | Acid dissociation & Bridge ELISA |
| Residual Trypsin (Porcine & Bovine source) | 1D/2D , 1D 2D WB, a,b | Sandwich ELISA | Anti Trypsin antibody assay | Acid dissociation & Bridge ELISA |
| Residual antibiotics | Enquire | Enquire | Enquire | Enquire |
| Product isoforms | Enquire | Enquire | Enquire | Enquire |
- ADA: anti drug antibodies
- AD: Acid dissociation
- PK: Pharmacokinetics
- TK: Toxicokinetics
- LBA: Ligand binding assay
- a,b: Colorimetric , Chemiluminescence detection platform
- IP: Immunoprecipitation
BIOCHEMISTRY KITS
Lipid Profile
- AFFI CC PLUS – Cholesterol
- AFFI CC PLUS – HDL
- AFFI CC PLUS – Triglycerides
Diabetic Profile
- AFFI CC PLUS – Glucose
Pancreatic Profile
- AFFI CC PLUS – Alpha Amylase
Renal Profile
- AFFI CC PLUS – Creatinine
- AFFI CC PLUS – Urea
- AFFI CC PLUS – Uric Acid
Liver Profile
- AFFI CC PLUS – Albumin
- AFFI CC PLUS – ALP
- AFFI CC PLUS – Bilirubin Direct
- AFFI CC PLUS – Bilirubin Total
- AFFI CC PLUS – GGT
- AFFI CC PLUS – SGOT
- AFFI CC PLUS – SGPT
- AFFI CC PLUS – Total Protein
Cardiac Profile
- AFFI CC PLUS – CK MB
- AFFI CC PLUS – CK NAC
- AFFI CC PLUS – LDH
Molecular Diagnostic Products
Covid -19 Kits
- ACT-1 RTQPCRTM
- AFFIMAGTM
- AFFISPINTM
Manufacturing facility
Affigenix Biosolutions Pvt Ltd.,
No.88 & 89, SIDCO Industrial Estate,
Alathur, Thiruporur Taluk,
Chengalpattu Dist,
Tamil Nadu – 603110.
919632481000
info@affigenix.com
http://www.affigenix.com/home
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