Biologic Drug Analytics
Manufacturing and QC
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Biologics Manufacturing and QC
Early strategic approaches and the application of advanced analytics before critical stages can improve product development, manufacturing, and clinical outcomes. ProtaGene offers industry-leading strategies, state-of-the-art analytic platforms run under GMP quality systems, and specialized expertise across both Europe and the US to help advance your manufacturing and product-facing analytical programs such as:
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Manufacturing and Process Analytics
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Method Development
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Phase Appropriate Validation
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QC-lot Release
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Stability Program Management
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Analytical Life Cycle Management
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Host Cell Protein Analysis
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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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bullet Created with Sketch. Multi-subunit complexes—protein, nucleotide, ligand
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bullet Created with Sketch. mAbs
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bullet Created with Sketch. ADCs and protein conjugates
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bullet Created with Sketch. PEGylated proteins
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bullet Created with Sketch. Bispecifics/multispecifics
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bullet Created with Sketch. Fusion proteins
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bullet Created with Sketch. Enzyme replacement therapies
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bullet Created with Sketch. Biosimilars
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bullet Created with Sketch. Vaccines, including subunit/recombinant
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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.
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