Cytovance® has a 10+ year track record of successful technology transfer to support a wide range of biologics and clinical stages. Our core objective is to ensure that the contracted activities are well aligned with our clients’ objectives, whether they are focused on scale-up from early stage development phases to commercial manufacturing, expanding commercial scale to meet new market demand, or modifying the manufacturing process to improve process economics. Each customer project is customized to match the required scope and clinical phase. Commercial and in-house mammalian and microbial platform processes enable efficient movement through development programs and into commercialization.
The keys to successful technology transfer at Cytovance® are: effective planning, clear communication and seamless integration of key stakeholders groups (R&D Services, Manufacturing Sciences & Technology (MS&T), Manufacturing, Quality Control, and Quality Assurance). To ensure cross-functional alignment, efficient communication, and adherence to timelines, each clients’ project is assigned a dedicated, experienced program manager.
External technology transfer
Facility fit/gap assessment
Analytical development services
Platform assay verification/in-house assay evaluation
Analytical method transfer
Analytical method development
Analytical method qualification
Upstream process transfer and demonstration at bench scale
Downstream process transfer and demonstration at bench scale
Pre-formulation and limited accelerated storage stability studies
Non-cGMP engineering run
cGMP production run