Process Development

Our Approach To Process Development

Process development is critical for the success of commercially-viable, safe products. At Andelyn Biosciences, we use a set of rigorous process development guidelines to establish, implement, and improve our manufacturing processes.

By tightly controlling our manufacturing processes, we ensure that your products are made in an aseptic environment, meet your quality specifications, and maintain this quality when created at scale.

Not only that, but through every step of pro process development, we work closely with your team to ensure that we prioritize quality and reproducibility of your products – as well as affordability when manufacturing at scale.

Creating an AAV, plasmid, or other product from a research lab is one thing, but a lot can change when processes are being established to create the product at an industrial scale. Andelyn uses a controlled environment, advanced equipment, and a systemic approach to process development to ensure your products remain consistently high in quality as they’re scaled for commercial manufacturing. 

But don’t take our word for it. We provide comprehensive documentation when manufacturing products – including analytical testing, reports, SOP information, batch records, and defect testing to ensure your final product meets all of your requirements.

Process Development
The Verdot FlexiPro supports purification of viral products with single-use tubing to eliminate cross-contamination between AAV viral vectors.

Andelyn Bioscience Process Development laboratory capabilities:

  • Cell culture customization and scale up using adherent or suspension platform 
  • Scale for adherent: 1L to 10L-CellSTACK and 36-Layer HYPERStack® 
  • Scale for suspension: 125mL to 5L flask and Pall Stirred Tank Bioreactor STR 50L and 200L
  • Selection or Optimization of media, additives, cell line, harvest conditions (media / cells), cell lysis
  • Large and small-scale chemical transfection optimization using PEI or Ca3(PO4)2; 
  • Production Parameter development: DNA:PEI ratio or Ca3(PO4)2
  • Bioprocess Filtration 
    • Depth Filtration
    • Tangential Flow Filtration
      • Hollow Fiber 
      • Flat Sheet Cassettes
    • Tangential Flow Depth Filtration (Repligen)
  • Large and small-scale column chromatography-based purification and optimization (affinity, ion exchange, hydrophobic and mixed-mode). Columns used include Monolith (BIA), OPUS® (Repligen)
  • Process and Material Qualification
  • Technology Transfer to GMP and Research AAV Manufacturing Facility
  • Investigational Experiments on Atypical Observations
  • Final Formulation Buffer Optimization
  • Small Scale Production Runs
  • In-process Stability Testing
 
Process Development
Using the Pall Bioreactor STR200, a single-use bioreactor

Process Development Analytical Capabilities Include:

  • Measurement of metabolites and cell growth parameters
  • Physical characterization of AAV including viral purity (gel electrophoresis)
  • Viral titers and yield (qPCR, ddPCR) 
  • DLS 
  • Capillary electrophoresis
  • Free DNA measurement

Why Use Andelyn Process Development? 

We have more than 20+ years of experience developing a wide variety of biopharma products including plasmids, AAVs, and more. 

Throughout the years, we’ve developed a unique approach to process development that uses modern best practices and our deep expertise in product manufacturing – empowering our clients and customers with safe, reliable, and high-quality AAV vectors and plasmids for gene therapy.

To learn more and to see why Andelyn Biosciences has developed a reputation for excellence in process development, contact us online. We’d be happy to discuss our services in more detail, or to learn more about your project and how the team at Andelyn can help.