Advanced Technologies and Integrated Services for Biosimilars
Catalent Biologics has extensive experience in biosimilar development, with a total of 7 biosimilar products on the market utilizing our technology. We offer flexible and customizable development programs beginning with innovator sourcing, full analytical characterization, early cell line development utilizing our GPEx platform, process development, scale-up, cGMP manufacturing, analytical testing and clinical trial supply services. We also can offer our clients a portfolio of developed cell lines to accelerate biosimilar development across multiple therapeutic areas.
Suite of Services for Biosimilar Development
We have the expertise and flexibility to create tailored solutions for your unique program needs.
- Clonal cell line (master cell bank candidate) employing our GPEx® technology
- Biosimilar process development using DOE enabled by the ambr® platform and integrated analytical services
- Flexible cGMP manufacturing from 10L to 2000L scale
- A comprehensive suite of analytical capabilities
- Sourcing of innovator/comparator product
- Fill/Finish – including Blow / Fill / Seal Technology, pre-filled syringes and glass-free injectables with ADVASEPT™ technology
- Clinical packaging, warehousing and global distribution
Depth of Analytical Services for Characterization and GMP Release/Stability
Why Catalent for a Biosimilar Development Solution?
- 40% of marketed biosimilar mAbs utilize GPEx® technology, 7 marketed biosimilars
- High performance, high yield cell line development with GPEx® technology
- Comprehensive biosimilarity expertise and analysis tailored to your needs
- State-of-the-art manufacturing capability utilizing single-use bioreactors
- A spectrum of fill/finish solutions, including ADVASEPT™ glass-free technology
- Industry leading clinical trial supply with reference drug sourcing and blinding