Process Transfer CDMO Services
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.
KEY MILESTONES
- External technology transfer
- Facility fit/gap assessment
- Risk 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
- Pre-production activities
- Non-cGMP engineering run
- cGMP production run
- Campaign reporting