BIOSIMILARS
cGMP-compliant clonal cell banks.
Exceptionally high productivity.
Flexible deal terms.
Proprietary CHOExpress® transposon-based technology with clinical and commercial (BLA) track record.
Benefit from our dynamic portfolio of biosimilars, de-risking your preclinical pipeline with seamless integration of upstream (USP) and downstream processes (DSP).
Ready-to-use (off-the-shelf)
- Highly productive, robust biosimilar clonal lines
- Research (RCB) and cGMP master cell banks (MCB)
- Manufacturing processes (USP, DSP) and respective analytics available
- Biosimilarity as defined by FDA/EMA guidelines
- Cost-effective solutions
Tailored on-demand
- Process development (USP, DSP)
- Biosimilarity tailor-made to market demands
- Scale up up to 200L
- Analytical packages
- Characterization of MCBs
- cGMP cell bank ready in less than 11 months
Top clone RCB titer up to 8 g/L,
98% of clones are stable
Cell culture protocols and
CMC-compliant documentation included for all cell banks
Critical quality attributes (CQAs) based on multiple reference lots including but not limited to:
Glycan profile,
Charge distribution,
Purity
Our biosimilar pipeline
Available for buy-out or licensing with regional or global rights.
Biosimilars generated from our cell lines consistently match critical quality attributes of the originator lots, ensuring identical performance and efficacy in the clinical trials with robust process scalability.
Glycoprofile Analysis
Explore our case study showcasing the development of a biosimilar until a cGMP master cell bank, including multiple successful confirmational runs at 40L.
Request a free quote for your project today.
From DNA to product: do it right, from the start.