A suite of cell line development (CLD) services with your priorities in mind for any molecular format
CLD requires generating single cell-derived clones that produce high and consistent levels of target therapeutic protein.
Once the lead candidate has been identified and a vector generated for use in the selected host cell, the CLD process begins. The process will be tailored to fit the molecule and program needs.
The vector is transfected in a monoclonal host cell line that will not only be able to deliver high titers and desired product characteristics, but also be transferable to manufacturing. At the end of the CLD process, a lead manufacturing cell line will be selected and a research cell bank generated.
The combination of host cell line, vector and stringency of selection enables us to provide our customers with high producing cell lines suited to fit a commercially relevant process.
Advanced technologies used to enhance yield and shorten timelines
Creating cell lines with future manufacturability, cost of goods and speed in mind is of critical importance in today’s biopharmaceutical development.
In addition, there is a large shift in biologics drug development pipelines to newer and more complicated formats. Those next-generation molecules require appropriate expression technologies to realize their potential.
By working with our expert cell culture teams in our Slough (UK), Visp (CH), Guangzhou (China) and Tuas (SG) sites, you will benefit from our advanced technologies and from our GS Gene Expression System® toolbox: including GS Xceed® and GS piggyBac® to develop a recognized and stable cell line.
Building on more than 35 years' experience, we can support the development and manufacturing of a large variety of molecules ranging from simple monoclonal antibodies to fusion and scaffold proteins.
Our services can be customized to accommodate your priorities in terms of timeline, yield optimization, budget and risk.
Examples of technologies enabling our CLD offering
Transfection: GS piggyBac®
Transposon technology that allows a targeted insertion of the DNA in high-performing regions of the genome. Combining our GS System® with piggyBac™ transposon technology results in increased yields with both pools and clones.
Cloning: Beacon™ Opto-fluidic Technology
Fully enclosed multifluidic platform designed to significantly shorten the cell selection process and bring your molecule into clinical testing faster.
Expansion: GSv™ Platform Process
GSv9 Media and Feeds to unleash the full expression potential of your protein, enhancing product quality
Achieve a seamless transition from development into cGMP manufacturing
Your cell line will be developed using procedures based on achieving high product titers and the desired product characteristics. Selection experiments carried out in miniature bioreactors with an abridged version of our platform manufacturing process will help to reduce risks at later stages and allow a seamless transition from development into cGMP manufacturing.
A close interaction with regulatory authorities worldwide eases regulatory hurdles, since these cell lines will be constructed, cloned, and characterized according to current regulatory guidelines. In addition, the use of electronic notebooks enables real-time data entry, reduces human error, and offers the full traceability required by regulatory authorities. To date, we have successfully supported over 145 IND/IMPD.
A dedicated cGMP unit within our licensed manufacturing facility is used to create master and working cell banks for subsequent manufacturing use. The cell banks are characterized in accordance with FDA and European regulatory agency requirements. For safety and security considerations, dual-site storage of all cell banks is maintained between our facilities.