Product Quality Attributes (PQA) Assessment

Abzena can undertake PQA assessment, this includes:

Product integrity

  • Confirmation of intact protein and subunit mass
  • Confirmation of subunit dissociation
  • Analysis for subunit loss and potential degradation
  • Confirmation of biosimilar concentrations

Product activity

  • Confirmation of binding characteristics
  • Confirmation of activity/functionality
  • Assessment of effector functions (ADCC/CDC) for antibodies

Product aggregation and purity

  • Analysis of product aggregation
  • Analysis of sample purity & confirm suitability of purification method

Product sequence confirmation and site specific modifications

  • Sequence coverage based on peptide mapping using LC-MS
  • Site specific modifications (deamidation, oxidation) using LC-MS

Product charged variants

  • Charged variants profiling using cation exchange chromatography

Working with Abzena

Our services are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results in a timely manner.

For more information or a quote for our PQA services and technologies contact us.

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GMP Manufacturing

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