Process Development & Biologics Development
Vista Biologicals supports biologics programs from early-stage development through process optimization and scale-up. Our work includes cell line development, process design, and refinement of upstream and downstream workflows to enable efficient, scalable production.
We work with clients to establish practical, robust processes that transition smoothly into GMP manufacturing. This includes development of both upstream and downstream workflows, with a focus on yield, purity, consistency, and regulatory alignment.
Process Development and Manufacturing Support
We support biologics development and process optimization across both upstream and downstream workflows, with a focus on establishing robust, scalable processes suitable for manufacturing.
Core Development Capabilities
- Cell Culture and Production Optimization
Development and optimization of cell lines and production processes, including clone selection, media optimization, and control of key parameters such as feed strategy, temperature, pH, and dissolved oxygen. - Purification and Downstream Process Design
Design and refinement of downstream workflows to achieve target yield and purity, including chromatography development, ultrafiltration and diafiltration, and integration of analytical methods to support process control. - Scale-Up and Technology Transfer
Support for scaling processes from laboratory to production, including process documentation, feasibility assessment, and preparation for transition into GMP manufacturing.
Why Vista Biologicals
- Experience with complex biologics and protein purification workflows
- Development of processes designed for scalability and manufacturing
- Alignment with regulatory expectations for clinical and diagnostic programs
- Integrated support from early development through GMP production
- Flexible approach to early-stage and non-standard programs
