We deliver robust, scalable processes based on focused technical transfer and development principles, and provide throughout a consultative partnership that delivers clinic-to-commercial need.
HIGH PRODUCTIVITY AND SCALABILITY
Phase-appropriate tech transfer and development services
We provide upstream and downstream process development services based on a systematic, stepwise methodology focused on the identification of the key process parameters for your project. Our approach is resource efficient, reducing development time and costs, without compromising quality.
Our expertise in working with a variety of cell substrates and familiarity with a wide range of viruses makes us an ideal partner for complex projects. We can help you meet the expectations of your stakeholders, by deploying a strategy to your exact specifications to help you enter the clinic quickly, save resources, or develop a process with commercial requirements in mind.
Tech Transfer and Development
- In-house service in each US & EU facility
- Dedicated staff of expert process scientist
- On-site and integrated assaying & analytical development
- Cell line adaptation (adherent-to-suspension / serum-free)
- Virus seed cloning and genetic characterization
- Host cell infection & transfection efficiency
- Full Upstream (USP) & Downstream (DSP) evaluations
- Media, buffer, and formulation studies
- Expansion vessel evaluation (Stir-tank, Fixed-bed, Rocker, Roller, Cell Stacks, and more)
- Clarification and purification evaluation (Chromatography, Filtration, Centrifugation, and more)
Looking for something different?
Vibalogics can assist you through a comprehensive service portfolio – ensuring success of your virotherapy, beginning with process development and technical transfer feasibility, through cGMP production and validation.
Drug Substance & Drug Product
QC Release & Stability Testing
Overcoming Technical Transfer Challenges in Virotherapy Manufacturing
Technical transfer is the handover of knowledge and technical capability from one stage in the development supply chain to another and can take several forms. Here we share a brief guide to navigating the technical transfer process for viral vector projects.