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 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.
Questions about our capabilities?
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 (TFDF-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