Protein Characterization Services

Prolytix is a bioanalytical CRO with extensive experience characterizing critical aspects of large-molecule therapeutics, providing high-quality data to expedite decision-making. Our protein characterization services include:

  • Physicochemical properties
  • Biological activity/potency
  • Immunochemical properties
  • Purity, impurities, and contaminants
  • Quantity
  • Protein ID and quantification
  • Gel-band identification
  • Post-translational modifications
    • Oxidation
    • Deamidation
    • Glycosylation
    • Disulfide mapping
    • Pegylation
    • Phosphorylation
  • Aggregation
  • Charge heterogeneity
  • Host Cell Proteins
  • PS20/PS80
  • Relative Potency

Peptide Mapping

Gain a complete understanding of your protein’s structure with Prolytix as your peptide mapping CRO.

Using a multidisciplinary, bottom-up approach, our scientists determine protein identity and sequence coverage, as well as the location and extent of post-translational modifications (PTMs). This information is critical for ensuring drug product safety.

As a large molecule analytical and bioanalytical CRO, we provide peptide mapping for these and other samples:

  • Recombinant proteins and enzymes
  • Monoclonal antibodies (mAbs)
  • Polyclonal antibodies (pAbs)
  • Bispecifics
  • Chimeric or fusion proteins
  • Recombinant protein vaccines and virus capsid proteins
  • Plasma-derived or other naturally sourced therapeutics

Post-Translational Modification Characterization Services

Peptide mapping provides information about the primary structure as well as the location and extent of post-translational modifications (PTMs) within a protein. Prolytix offers a complete portfolio of solutions for PTM characterization to help you understand the biological structure of proteins and their biological processes. 

Customized PTM Characterization from Prolytix

We often use specialized conditions to fully characterize PTMs. A highly customized approach allows us to provide you with the most comprehensive information about a product.

Whether we use different enzyme digests or MS/MS conditions, Prolytix considers all factors when developing a PTM characterization approach.

Modifications include:

  • Deamidation
  • Oxidation
  • N-glycosylation
  • O-glycosylation
  • Disulfide mapping
  • Pegylation
  • Phosphorylation, acetylation, and more

PTM With High-Resolution Mass Spectrometry

Our scientists have experience in multiple approaches and methods, including high-resolution mass spectrometry (HRMS), which allows us to provide the data you need to move your advanced biologic project forward.

Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs

N-Glycan Analysis Service

N-Glycan and Glycopeptide Analysis Services

Have confidence in the consistency of your biotherapeutics manufacturing with glycosylation, including N-glycan analysis, from Prolytix. Our expertise includes tailored methods for neutral and highly sialylated glycans, mass spectrometry detection for glycan identity, and fluorescence detection for routine use.

Glycosylation, a common post-translational modification (PTM), plays an important role in recombinant protein bioactivity and pharmacokinetics (PK). Glycosylation is also an indicator of manufacturing consistency. We provide glycopeptide mapping, as well as released N-glycan profiling data, to give you the information you need for consistent, quality biotherapeutic development. 

N-Glycan Analysis Use Cases

  • Glycopeptide mapping
    • We can characterize glycans early in drug product development—as early as the cell line selection stage—to help clients select a clone that produces a product with the desired glycosylation profile.
    • We can analyze and process intermediate samples to ensure that fraction pooling maximizes the yield of a high-quality product, which is especially important when glycosylation is critical to potency or PK properties.
  • Released N-glycan profiling: We use released N-glycan profiling with fluorescence and/or HRMS detection to analyze the consistency of N-glycosylation in purified proteins.

Advanced Analytical Techniques

Prolytix uses liquid chromatography (LC) with tandem HRMS and fluorescence detection to analyze some of the most complex glycoproteins found in nature. Our experience includes characterizing products from cell culture, plasma, and milk.

Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs

Capsid Characterization Services

Capsid Characterization Services for Vaccines and Viral Vectors

For recombinant protein vaccines and viral vector development, including adeno-associated virus (AAV) development, viral capsid characterization with peptide mapping is important for ensuring drug product safety and consistency.

Whether you’re developing a viral vector for a novel gene therapy or a preclinical vaccine, Prolytix has the scientific expertise to help move your product forward with agility and speed.

HRMS and Capsid Characterization

We use LC-MS/MS—liquid chromatography (LC) with tandem HRMS—and several other applicable methods to develop peptide maps for capsid proteins. Our precise characterizations give you the identification and sequence coverage information needed for vaccine and viral vector projects.

Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs

Sequence Variant Analysis

Sequence Variant Analysis Services for Therapeutic Proteins

Don’t let sequence variants halt your viral vector or recombinant protein product development. Sequence variant analysis (SVA) is a challenging discipline that involves careful data analysis. Undetected sequence variants can affect a product’s safety and efficacy. Because sequence variants affect biological properties, early detection is key.

Prolytix has extensive experience with variant projects in microbial and mammalian expression systems. We’ve seen variants that range from ppm levels up to 10% at a particular site.

Sequence Variant Analysis Services for Therapeutic Proteins

Prolytix designs SVA experiments to maximize protein coverage at the MS/MS fragment ion level. Using HRMS, we scour the data for all possible single-base variants and manually confirm the search engine results to ensure absolute accuracy. We report the %SV (or ppm) for each sequence variant relative to the native/wild-type peptide.

Multiomics and LC-MS/MS solutions powered by strategic partner, Allumiqs

Protein Identification and Quantitation

Protein identification and quantitation, or proteomic services, are important early steps in large molecule discovery. Prolytix uses label-free analysis methods to identify and quantify the proteins in your sample and their distinct characteristics. 

Proteomic Analysis Applications

  • Cell culture fluid, cell lysate, tissue lysate, etc.
  • Affinity pulldown studies
  • SDS-PAGE gel-band or spot identification
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