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:
  • 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:
 
  • Screen several protein variants for binding and expression
  • Generate low-endotoxin protein for in vivo studies

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:
  • RCB within 10-12 weeks: 4-8 g/L clones
  • Highly stable clones for >120 generations
  • High Specific Productivity (Qp): 60-120pg/cell/day
  • >97% Monomeric protein
  • High expression of difficult proteins
Celltheon's clones are highly stable and productive with:
  • No gene amplification
  • No pool enrichment
  • No automated colony picking / HTS equipment required
  • No issues regarding clonality: full documentation with imaging
  • No CQA issues due to engineered cells
  • No animal origin or non-chemically defined media and feed supplements
  • No clumping issues or high ammonia levels that can lead to challenges at scale up in bioreactor

​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: 
  • ~20x improvement with media/ feed optimization
  • N-glycan profile optimization (increased sialylation and reduced fucosylation)
  • Charge variant optimization: deamidation, oxidation, N-terminal glutamine cyclization, aspartate isomerization. Incomplete disulfide bonding, etc.
  • Reduced aggregation: >99% Monomer
  • Ensure scalability via defined kLa, P/V and tip speed 
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:
  • Resin screening, method development, optimization, etc.
  • Optimization of each unit operation:
    • Harvesting and Clarification
    • Protein A, Anion Exchange, Cation Exchange, HIC, IMAC, Mixed-Mode Chromatography
    • Viral Inactivation and Filtration
    • TFF: UF/ DF
  • Improved recovery efficiency
  • Improved purity
  • CQA optimization Transferability and Scalability of final process

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:
​
  • 50L Stirred-tank Single-Use Bioreactor
  • 200L Stirred-tank Single-Use Bioreactor
  • 5, 10, 20 and 50L WAVE Bioreactors
  • Depth Filtration for clarification
  • Multi-column Chromatography (Protein A, Ion Exchange, IMAC, HIC)
  • UF/DF into formulation buffer
  • Analytical Assays: LAL Endotoxin, SE-HPLC, CEX-HPLC, N-glycan, HCP ELISA, etc.

​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:​
  • Quantitative ELISA
  • Octet- Protein Quantification and Affinity
  • HPLC (CEX/SEC/RP assays)
  • SDS-PAGE
  • Cell based assays
  • LAL Endotoxin
  • Host Cell Protein Assay
  • FACS assays
  • Binding assays
  • High throughput N-Glycan (CE-based assay)
  • Other assays are outsourced to our preferred vendors/ partners