Biologic Drug Analytics
Product and Process Development
Read Our New White Paper
Content and Degradation of Polysorbates in Biopharmaceutical Formulations
We present orthogonal analytical procedures for quantification of the total polysorbate content, determination of polysorbate identity, as well as characterization and quantification of polysorbate degradation products. The methods presented here provide a powerful toolbox for the control of polysorbate quality and stability in polysorbate-formulated biopharmaceutical drug products as requested by health authorities.
Biologics Product and Process Development
ProtaGene’s service portfolio includes a comprehensive suite of analytical methods to address the development of complex biologic drug substances, including full characterization panels, GMP level QC lot release, and stability methods.
Our global sites are equipped with modern, state-of-the-art equipment run under best-in-class quality systems for the analytical characterization of biopharmaceuticals, including structure, purity, chemical modification, aggregation, particle formation, and thermal stability. We offer analytical support service modules from research to market, such as:
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Developability and lead selection
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Preformulation/formulation development
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Real-time and accelerated stability
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Forced degradation program design and management
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Scale-up and process comparability
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Early MAM development and qualification
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Impurities and residuals process clearance studies
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Host Cell Protein Analysis
Analytical Solutions from Research to Market
Biologic Therapeutics Platform Expertise
Our deep experience advancing a diverse range of therapeutic platforms from research through market help the ProtaGene team design highly effective analytical programs that de-risk development and accelerate timelines to your next key milestones. Key biologic development areas include:
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Recombinant proteins—including complex, highly glycosylated proteins
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Multi-subunit complexes—protein, nucleotide, ligand
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mAbs
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ADCs and protein conjugates
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PEGylated proteins
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Bispecifics/multispecifics
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Fusion proteins
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Enzyme replacement therapies
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Biosimilars
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Vaccines, including subunit/recombinant
Analytical Systems
Enabled by state-of-the-art technology, ProtaGene offers an extensive range of analytical capabilities to support your biotherapeutic or gene & cell therapy projects.
