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Biologics
Our company provides a comprehensive range of services to assist with pre-clinical, clinical comparability and biosimilarity assessment.
Bioanalytical
- PK Assay
- PD Assay
- Immunogenicity Assays
- Chromogenic Assays
Cell Based Assays
- Single cell cloning
- Cell line charecterisation
- Cell Proliferation Assays
- ADCC/CDC
- MoA Development Extrapolatory studies
- NAb Cell based Assay
- PBMC Assay
- Potency and Efficacy assays
Biochemical Characterization
- Protein purification and quantification
- Peptide fingerprinting
- Impurity profiling
- Intact Mass analysis
- Disulfide mapping
- N terminal sequencing by LCMS-MS
Biologics Services in numbers
ELISA STUDIES
100
+
CELL BASED ASSAYS
40
+
TEAM
12
PROTETIN CHARATERIZATION STUDIES
56
MOLECULAR BIOLOGY
10
Biologics Credentials
- Somatropin PK and PD (IGF1 and IGFBP3) – ANVISA
- Longacting Human Growth Hormone PK and PD (IGF1 and IGFBP3) – ANVISA
- Complex Generics (LMWH/Heparin) with Anti IIa & Anti Xa Assay, chromogenic assays, TFPI Assay, HIT Immunogenicity, Characterization of PF4-LMWH complexes as per USFDA and EMA regulatory requirement
- Trastuzumab with Pharmacokinetic and Immunogenicity Assay as per USFDA regulatory requirement
- Insulin/Insulin analogues with physicochemical characterisation and Bioassays like Glucose uptake, Inhibition of Lipolysis, Lipogenesis, Mitogenic Assays, - USFDA
- Recombinant Hormones (HCG, FSH, EPO, Anti-D) with Pharmacokinetic and Immunogenicity Assay - USFDA.
- Dengue Virus MAb with Pharmacokinetic Assay -USFDA.
- RBD Specific & Total Fab-2 for Covid patients with Pharmacokinetic Assay - USFDA.
Biologics Lab
- We assess clinical comparability through Immunogenicity, PK, PD assays utilizing ELISA Assay format.
- Our lab is equipped to handle protein characterization, which involves analyzing the structure and properties of biologic molecules.
- We are equipped to perform bioassays to evaluate the potency and biological activity of biologic drugs.
- We have a collection of cell lines, which we use to conduct a wide range of Bioassay experiments and studies.
Cell Lines
We have different cell lines available to support our biologics services. These cell lines are carefully selected and maintained to ensure the highest quality and consistency of our services.
CANCER CELL LINES
- Liver Cancer (HEPG2, H4IIE)
- Breast Cancer (SKBR3)
- Epiderma (A-431)
- Lukemia (K-562, THP-1, KU-812, U937, TF-1, Jurkat E6-1
- Osteocarcoma (Saos2)
- Lymphoma, NK92MI, Daudi, RAJI, Wil2S)
PRIMARY CELL LINES
- Vein of umbilical Cord (HUVEC)
MOUSE CELL LINE
- Fibroblast (L929)
- Sarcoma (WEHI 164)
- Leukemia (RAW 264.7, M-NFS60)
- Lymphoma (SP2/0)
- Embryonic (3T3MBX, 3T3L1, BALB/3T3, CloneA31)
RAT CELL LINES
- Lymphoma (Nb2-11)