Celltheon Corporation uses novel genetic and process technologies to produce high quality cell lines and research level quantities of protein material for the easiest and most difficult to express proteins including bi/tri-specififc, DARPins, enzymes, growth factors, membrane proteins and antibody fragments/fusions. The CELLTHEON SMART™ Platform ensures high quality and high titer through newly developed, yet highly robust technologies such as Celltheon SUPERCELL™, suPRE™, and CT STABILIZER™. All of which have been seamlessly integrated into the CELLTHEON SMART™ Platform for fast and worry-free protein production.
Benefits of the CELLTHEON SMART™ Platform and Services include:
Benefits of the CELLTHEON SMART™ Platform and Services include:
- Rapid timelines
- Increased efficiency
- Cost savings at all production scales
- Higher quality protein for safer therapeutics
- Consistent CQA’s from thoroughly defined, QbD based processes
TRANSIENT TRANSFECTIONS
Celltheon offers high titer transient production to streamline early drug development and lead candidate validation. Implementation of the Celltheon suPRE™ and CELLTHEON SMART™ Platform results in a 10x increase in transient titers over comparable competing platforms. Within 10-12 days, Celltheon can generate your early stage material to:
|
CELL LINE DEVELOPMENT
The CELLTHEON SMART™ Platform for cell line development employs novel production technologies to shift the focus of clone screening from expression to product quality.
Celltheon’s homogenous high titer clone development platform allows for minimal clone screening with the following attributes for all screened clones:
|
Celltheon's clones are highly stable and productive with:
|
PROCESS DEVELOPMENT & OPTIMIZATION
Upstream Process Optimization
Our process development scientists have several years of experience in upstream process optimization. Up to 10 3L bioreactors may be run in parallel to quickly and efficiently determine and deliver a defined, scalable, and production ready process. Pilot-scale Single Use Bioreactors (50L and 200L) can additionally be used to ensure process scalability prior to GMP tech transfer. Celltheon understands the complexity associated with process scale-up and strives to reduce tech transfer and scale-up timelines. Celltheon process development goals include:
|
Downstream Purification Development
Celltheon’s expert scientists routinely replicate and develop new purification processes, improve and trouble-shoot existing purification steps, and systematically evaluate process parameters to improve purification efficiency and recovery rates. These purification processes are developed using industry standard, commercially available purification equipment and platforms. Through working closely with the customer, we ensure successful realization of desired process goals such as:
|
SCALE-UP
One of the most common sticking points for a novel biotherapeutic entering clinical manufacturing is process scale-up. Processes commonly developed at CRO's are made for small scale production and designed with limited process transferability characteristics. Celltheon's team of expert bioprocessing scientists design all Celltheon SMART™ processes such that processes are scalable to any reactor system and any reactor size with no additional development. Further, Celltheon has strong experience in quickly altering previously developed processes to improve scalability and perform pilot runs at 3, 10, 20, and 50L bioreactor scales.
|
BIOPRODUCTION (GLP)
Celltheon has many Single Use Bioreactors (SUBs) for small-to-mid-scale, non-GMP production. Following process development, Celltheon can scale up processes and perform multi-column chromatography to deliver purified, low-endotoxin protein for in vivo studies. Celltheon has already delivered several-hundreds of grams of purified protein for tox studies to clients. Bioproduction offerings include:
|
ANALYTICS
At Celltheon, quality by design (QBD) is built into our cell line development workflows and clone selection procedure. With a suite of optimized assays, we routinely screen clones in a high throughput fashion to achieve high quality production cell lines with minimal time and cost investments. Services include: