Cell Therapy Analytical Development
OmniaBio understands that strong analytical capabilities are a key enabler for CGTs. To support process development and manufacturing, we can provide a suite of qualified assays and flexible solutions through custom assay development.
Integrated Throughout Your Entire Process
We deploy in-depth analytical analysis for your product from process development through manufacturing, offering critical quality control testing, high-throughput screening assays, and ICH stability studies. By characterizing both your product and your process with robust methods, we can ensure to deliver you a well-defined product, making scale-up for commercial manufacturing seamless.
A Seamless Integration of Development and Manufacturing
At OmniaBio we know the value of convenience, which is why we offer analytical development, process development, and GMP manufacturing as integrated services under one roof. Our collaborative teams work together to reduce time and costs associated with getting your product to market.
Our Cell Therapy Analytical Development Capabilities
- Qualified standard assays for immunotherapies to quantify potency, purity, cell number and viability
- Qualified assays for viral vectors to quantify infectious titre, physical titre, residual host cell protein and DNA
- Full impurity testing panel
- Custom assay development for viral vectors, immunotherapies, and PSC-based products Integrated assay development and quality control teams to support technology transfer of custom assays
- Automated platforms for high-throughput development and screening
Featured Case Study
Process Development for Scaled-Up hESC/hiPSC Manufacturing
As a CCRM subsidiary, OmniaBio is building on an established foundation and reputation in manufacturing for cell and gene therapies, expanding on a knowledge base and legacy that has been built over a decade. Together, we are meeting the needs of our CDMO customers. In less than 12 months, we developed a best-in-class, scalable manufacturing platform with closed passaging and in-line analytics that optimized a 14-day manufacturing workflow and produced >1010 cells per batch.
Analytics in Every Area of Expertise
Immunotherapy
Best-in-class solutions for cell therapy development and manufacturing
Lentiviral Vectors
Enhancing gene delivery through end-to-end developmental support
