Tox Material Production
Have you been limited a lack of tox material to properly design your pre-clinical toxicology studies in animals? We will help you plan experiments without the worry of running short. We can deliver up to 500 grams of drug substance from a single batch, in 8 months or less.
Our scientific foundation is built on expert knowledge, dependable quality, and timely delivery. You can trust ExcellGene to obtain hundreds of grams of purified protein in less than 8 months.
What we do
- Generate stable recombinant cell lines and development
- Clonal cell population with matching media and feeds
- Stability studies > 3 months, > 100 population doublings
- USP development (process optimization for high yield and product quality)
- Process verifications and scale-up in fully controlled stirred bioreactors (1.5, 10, 40 L)
- Fed-batch processes with 3-14 g/L yields
- DSP development, small scale, high throughput
- DSP process development for larger scale
- Holding step studies
- UF/DF and pre-formulation studies on drug substance
- Filtration, filling and storage of up to 500 grams of drug substance
- Target product purity (endotoxin free, host cell DNA: < 100 ppb, HCP < 100 ppm, LAL < 1 EU/mg, product purity > 95% main form @ SE-HPLC)
In the CHOExpress™ system, a 1.5 L stirred tank reactor (A) can already produce similar cell densities and viabilities and titer as a pilot scale 40 L stirred tank reactor (B).
ExcellGene is known for quality execution and timely delivery of client materials. Each project is customized to our clients’ requests. We carefully select all materials used in our processes to prevent the transmission of contaminants and to deliver the purest product possible.