Recombinant Protein Technologies

VCARE is a precise and comprehensive platform for Biopharmaceutical / Vaccine industry and it provides precision solutions under one roof (Research to manufacturing) across the globe.Our experience over the years in the development of biologic products with a deep knowledge of regulatory requirements, we have created a eco-system to support our clients’ for biosimilar development programs

VCARE Biolabs as your outsourcing associate, with our strategic approach towards design, develop and authenticate the cloning, upstream, downstream process and analytical method developmentbrings together timelines and cost effectiveness to our clients.

Molecular Biology

VCARE biolabs dedicated molecular biology group provides a broad range of custom designed cloning services for thriving recombinant protein expression. Our services include designing of gene, codon optimization and clone into desired expression vector of choice  as per regulatory requirements (all constructs are fully verified by DNA sequencing).

Cell Bank Characterization Studies

VCARE Biolabs has facility and expertise for preparation and characterization of Master Cell banks and Work cell banks. Our cell bank characterization services includesIdentification tests, purity test, copy number and DNA sequencing

Fermentation process Optimization

✯ Strain development
✯ Media optimization studies, Upstream process optimization and scaleup
for E. Coli, yeast and mammalian cells
✯ Process Analytical Technology (PAT) and process control systems at development to commercial scales
✯ We shall apply DOE principles during process development and scaleup studies.

Purification process optimization

VCARE biolabs offers a variety of purification services for recombinant proteins, antibodies (including fragments and modified proteins. Native proteins, fusion proteins by using different techniques like affinity, ion exchange, Gel filtration,HIC, and IMAC chromatography. 

Analytical Method Development

The Analytical Research & Development Division at VCARE is a well-equipped laboratory with capabilities to perform pharmacopeial / non Pharmacopeial tests.
Our highly skilled method development scientists have acquired years of experience, working across multiple products, methods and analytical technologies to ensure that the method will be ‘fit for rationale. Our know-howcovers a variety of molecules and formulations that include small molecules, biosimilars, vaccines etc.

Analytical Method Validations

Validations for related substance, assay, residual solvents, 
 dissolution profile, trace metals, HPLC systems with UV, fluorescence detectors, RI detectors, conductivity detectors and PDA detectors, ELISA, HCPs, HcDNA etc

Characterization of proteins/peptides and Biosimilars

Biosimilars are complex protein structures that are difficult to characterize.  Variations can occur in the nature of biosimilars even under stringent GMP conditions, which in turn affect both efficacy and tolerability. ✯ Immunoblotting ✯ Peptide mapping ✯ CD Spectroscopy ✯ Fluorescence Spectroscopy ✯ UV Spectroscopy ✯ Peptide / aminoacid sequence ✯ Disulfide bonds analysis ✯ Isoelectric focusing ✯ Mass Analysis ✯ Glycan analysis ✯ SDS-PAGE (Reducing & Non reducing) ✯ RP-HPLC ✯ SEC-HPLC ✯ Host Cell Proteins ✯ Host Cell DNA ✯ Bioassays (in vitro/in vivo).

Bioassays

As a leader in specialized and complex bioassay development and testing, VCARE biolabs combines state-of-the-art cell-based assay facilities with a veteran team of scientists well-versed in the quality and regulatory demands of biological assay development to support customers innovating in the areas of biologics, biosimilars, and biobetters.

Stability Studies

✯ Real time stability studies
✯ Intermediate stability studies
✯ Accelerated stability studies
✯ Photostability studies & Forced Degradation studies
✯ Drug & Excipient compatibility studies

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