Cell Line Development
Parental cell lines
GMP and regulatory compliant CHO DG44 and CHO-S suspension host cell lines have been adapted into animal origin–free (AOF) chemically defined media. We offer low licensing access to these established and well-characterized parental CHO host cell lines that are banked under cGMP guidelines with complete lineage documentation packages to streamline regulatory filings, to help make it more cost-effective and easier for IND filing.
Vector design and construction
Optimization of vector construct can increase expression level of the desired genetic elements. Therefore, each of our CHO cell line platforms is complemented with vectors designed for high-level expression. Our vectors help ensure:
- Rapid cDNA integration into a vector of your choice using our proprietary cloning technologies.
- A final sequence-verified stable construct suitable for your expression needs.
In addition, licensing of these vectors helps ensure access to a diversity of elements with freedom to operate and a clear line of sight to financial commitments through commercialization.
Transient protein expression
transient transfection of mammalian cells has become increasingly important to produce milligram quantities of a recombinant protein for characterization and pre-clinical studies. We have the expertise to assist in:
- Establishment of the cell line, culture conditions, expression vector, and transfection agents for the optimal transient expression system in adherent or suspension cultures.
- Use of our serum-free Gibco™ Freedom™ expression system to produce protein in suspension CHO and 293 cultures in short time frames.
Stable cell line development
The ability to generate high-expressing cell lines with rapid, cost-effective, and scalable methods is becoming increasingly critical. We have streamlined our cell line development process with proven workflows from our cell line development kits, in combination with an integrated suite of technologies that encompass the following:
- Use of established serum-free media for the entire workflow leading to a seamless transfer into process optimization.
- Serum-free cloning to avoid animal-origin material contact and improve control over product development.
- High-throughput screening for the most productive clones, accomplished by ClonePix™ technology.
- Availability of integrated base and feed media platforms for clone screening enabling shorter process development timelines.
the stability of selected clones over long-term culture is a critical parameter for commercial production. An unstable clone can cause a dramatic drop in titer to a level unsuitable for a production process. We offer services using standard protocols assessing cell growth rates and proliferation, and protein expression stability over time. This helps clients avoid future problems due to cell line instability.
Cell line banking
we offer multiple outsourcing options for all GMP Master and Working Cell Banks related work, ranging from cell bank creation to characterization, including the following:
- Extensive testing of any seed stock using multiple validated assays
- GMP preparation and characterization of the MCB and WCB
- Cell bank storage with clear traceability and strict maintenance and security