Overcome the major challenges in gene therapy with PROGEN's portfolio of AAV antibodies

PROGEN´s unique portfolio of AAV antibodies allows process monitoring and quality control of the complete value chain

25 Oct 2022
Dora Wells
Clinical Content Editor

Adeno-associated viruses (AAV) represent the most commonly used viral vector for the delivery of therapeutic transgenes. However, the gene therapy community is facing major challenges like the high demand for efficient production of high-quality AAV vectors in clinical scale quantities. Comprehensive monitoring of the VP proteins as well as the quality and integrity of the final vector product is an effective tool to ensure efficient and high quality manufacturing of AAV-based gene therapy products.

PROGEN´s unique portfolio of AAV antibodies allows process monitoring and quality control of the complete value chain, from production & purification, quality control & characterization to clinical safety & efficacy.

Identify, monitor, and optimize

The AAV capsid protein antibody clones A1, A69 and B1 are the most published, commercially available antibodies for the detection of the VP1, VP2 and VP3 AAV capsid proteins. The AAV capsid protein antibodies specifically recognize linear epitopes of the viral capsid proteins which consist of neighboring amino acids. During AAV vector manufacturing, these antibodies are used to verify the identity of the VP proteins, optimize particle yield and potency and support scale-up processes when used for consistent monitoring of the single steps.

Purify, characterize, and control

AAV particle antibodies, available for a broad spectrum of AAV serotypes specifically react with intact/fully assembled AAV particles, i.e. empty and full capsids. They recognize conformational epitopes consisting of distant amino acids that come in close proximity by the assembly of the three capsid proteins VP1, VP2 and VP3 of certain serotypes. Beside their use in PROGEN´s exclusive AAV ELISAs for titer determination they represent a unique tool for purification, characterization and quality control of AAV vectors. The neutralizing capacity of these antibodies further support the evaluation of clinical safety and efficiency aspects which is indispensable to meet regulatory requirements.

Key features

  • Unique AAV antibody portfolio
  • AAV capsid protein antibodies:
    • Detection of the AAV VP proteins
    • Verify proper expression levels to optimize the particle yield
    • Monitor protein ratios, having a major impact on the potency of the final product
    • Optimize production efficiency to ensure high yield production with high quality
  • AAV particle antibodies:
    • Detection of intact/fully assembled AAV particles
    • Monitor purification steps for more efficiency
    • Characterize final AAV vector product, e.g. proper assembly and integrity
    • Control antibody levels in patient sera to ensure clinical safety and efficacy

Applications

  • AAV vector manufacturing
  • AAV vector purification
  • AAV characterization and quality control
  • AAV neutralization assays

Relevant products

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