Process Validation

Critical to the Quality Assurance of Your Final Drug Product

We always operate with your end goal in mind and are experienced in providing your team with the tools to establish routine commercial manufacturing throughout the entire product lifecycle.

Support Through Every Stage

At Cytovance Biologics, we adhere to FDA and international guidance for manufacturing process validation by establishing scientific evidence that your process is capable of delivering a consistent and high-quality product through every run. From process design to process qualification and into continued process verification, we can help ensure that your manufacturing process is protected from variances that could interfere with the final drug product.

Milestones to Success

Your end goal is always at the heart of our work. We approach process validation with strategic milestones in mind to get you from process design to cGMP manufacturing. Starting with external technology transfer, we incorporate risk assessments, analytical method development and validation, process transfers, and ultimately execute cGMP production to deliver your final drug product to secondary manufacturing and clinical sites worldwide.

Seamless Transfer Capabilities

Team Cytovance provides deep experience in successful technology transfer support at any stage of your process and product development. We work closely with key stakeholders within your organization, third parties, and at Cytovance to ensure integration, cross-functional alignment, and clear communication to ensure efficient transfer of methodologies. No matter what phase, we have the capabilities to design and optimize critical assays or provide the necessary next steps to be cGMP-ready and validated for commercial manufacturing.