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Biologics Experience


PPD® Laboratories bioanalytical lab has worked with more than 3,000 different biologics.

PPD® Laboratories’ bioanalytical lab has been working with biologics since 1994 and helped develop eight of the top 10 biologics of 2015. The biologics development teams work closely with clients to understand the:

  • Intended use of the assay
  • Unique characteristics of the protein biotherapeutic
  • Potential interferences
  • Availability of reference materials and standards
  • Current bioanalytical regulatory requirements

With this knowledge our team can design and validate custom assays, or adapt existing assays, and quickly generate meaningful data to help inform project decisions.

Immunochemistry for Biologics

PPD Laboratories’ bioanalytical lab offers comprehensive immunochemistry services to support pharmacokinetic (PK) and anti-drug antibody (ADA) safety assessments. We have broad biopharmaceutical experience with a variety of molecules including monoclonal and multivalent antibodies, antibody fragments, oligonucleotides, PEGylated proteins and antibody drug conjugates (ADCs).

Our experience includes:

  • 655+ PK/PD ligand-binding methods
  • 260+ immunogenicity/ADA assays
  • 80+ oligomer/aptamer methods
  • 40+ plate-based neutralizing antibody assays


Chromatography/Mass Spectrometry for Biologics

Once traditionally a platform for small molecule analysis, mass spectrometry is now applied to the development of biologics. For the past several years, PPD Laboratories has been applying its three decades of experience with chromatography methods to the development and validation of LC-MS/MS analytical methods for biologics.

The bioanalytical lab’s experience applying LC-MS/MS and affinity capture LC-MS/MS methodologies to biologics includes:

  • Vast biologics diversity, spanning from small (1 kDA) therapeutic peptides to large (900 kDa IgM) proteins
  • A wide range of sample preparation methods from simple protein precipitation to complex affinity capture enrichment techniques
  • Development and validation of LC-MS/MS assays using surrogate peptides produced by proteolytic digestion for quantitation
  • Vast experience with bioinformatic software for identification of proteotypic candidate surrogate peptides
  • Semi-quantitative analysis of intact proteins (>10 kDa)
  • DAR Characterization of antibody-drug conjugates (ADCs) using high-resolution mass spectrometry (HRMS)

LC-MS/MS biologics capabilities include:

  • Intact peptides, atypical peptides, monoclonal antibodies, Fab fragments and fusion products
  • Antibody-drug conjugate (ADC) assays (preclinical and clinical):
    • Total antibody
    • Antibody-conjugated toxin (cleavable and non-cleavable linkers)
    • Conjugated antibody
    • Unconjugated toxin (auristatins, calicheamicins, pyrrolobenzodiazepines (PBD), tubulysins, maytansinoids)
  • Multidimensional chromatography for the quantitation of biotherapeutics, peptides, proteins and biomarkers
  • Preclinical and clinical matrices (fully regulated and nonregulated)

Our biomarker lab and our vaccine sciences lab are also deeply involved in the development of biologics and have significant experience with a wide variety of compounds, sample types and therapeutic applications.

 

Learn more about PPD Laboratories biomarker lab.

Learn more about PPD Laboratories vaccines sciences lab.


Explore our experience:

  • Small Molecule
  • Generics
  • Biosimilars
  • Vaccines Lab
  • Biomarkers
  • Vaccines Lab

 

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