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Comprehensive Process Development for Scalable Pharmaceutical Manufacturing

At Vista Biologicals, our process development unit delivers tailored solutions that bridge early-stage innovation and scalable pharmaceutical manufacturing. Whether you are refining a cell line, optimizing a purification scheme, or preparing for technology transfer into GMP production, our experienced team guides your project through every key step. With decades of expertise in biologics and protein purification, we specialize in designing processes that are robust, cost-efficient, and aligned with regulatory expectations.

Process Development

We support both upstream and downstream process development – combining cutting-edge cell culture, fermentation, and purification workflows with a mindset toward seamless hand-off into full-scale pharmaceutical manufacturing. Our goal is to ensure that your process is optimized not only for yield, purity, and consistency but also for scalability, regulatory readiness, and long-term manufacturing success.

Stem Cells Immunotherapy

Key Process Development Capabilities

  • Cell Culture and Production Process Optimization
    We work with cell line creation, high-productivity clone selection, serum-free or suspension adaptation, and optimize fed-batch, perfusion, and batch workflows with parameters such as feed rate, temperature, pH, and dissolved oxygen.
  • Purification and Downstream Process Design
    Our team designs and refines downstream processes to achieve targeted yield, purity, endotoxin, and viral-clearance goals. We provide assay development, chromatography parameter screening, ultrafiltration and diafiltration, and complete purification-train optimization.
  • Technology Transfer and Scalability
    From pilot to late-phase production, we support scale-up considerations, manufacturing feasibility, documentation, and regulatory compliance so that the transition into GMP production is smooth, efficient, and reliable.

Why Partner with Vista Biologicals

By choosing Vista Biologicals for your process development needs, you gain access to a partner that understands both the research horizon and the rigor of manufacturing. We integrate sophisticated R&D-driven workflows with the discipline of pharmaceutical services and full-scale pharmaceutical manufacturing.

  • Our team has more than three decades of experience in biologics process development and cell culture manufacturing.
  • We align methodologies with regulatory best practices and manufacturing requirements, ensuring readiness for GMP production.
  • Our customized development support means you receive a workflow tailored to your molecule, modality, and scale requirements.

If you are advancing novel biologics, seeking to optimize yield or purity, or preparing your process for commercial-scale manufacturing, Vista Biologicals is ready to be the expert partner that takes you from development into production-ready success.

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