Product and Process Development - ProtaGene

Biologic Drug Analytics

Product and Process Development

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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

Analytical Solutions from Research to Market

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Research
Preclinical
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Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

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Phase I
Phase II
Phase III
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Phase I – Phase III

Release, Clinical Data and Characterization Packages for Accelerating Phase I-III Programs through BLA

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Registration
Market
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Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

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

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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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