Protein Expression Platform
Fast, Predictable Results Designed for Robust Commercial Scalability
Development of new protein therapeutics is a complex process, with technical and regulatory hurdles to overcome in the path to commercial success. With increasing competition and the progress of biosimilars, drug developers need to focus on speed, predictability, and quality. The Sartorius CHO Platform, which brings together cell line development, fully optimized cell culture media, cell banking, and product characterization services in one integrated solution, accelerates your program and puts your molecule on the path to success. Our unique platform offers reduced cost and proven results while maintaining an exceptional degree of flexibility for drug developers.
An optimized media system maximizes cell growth, leading to high cell densities and high protein titers (up to 8 g/L)
A proven platform enables a fully characterized research cell bank in 14 weeks and a released master cell bank in less than five months
Simplify management and administration with one seamless process, from cell line development to lot release, via one experienced team
Our Cellca Cell Line Development is a royalty-free and milestone-payment-free service, removing licensing or partnering barriers
Our team has completed over 120 successful projects and brings 14 years of technical and regulatory expertise to every project
CHO Platform: A Complete Solution for Biopharmaceutical Drug Development
Sartorius has combined the industry-leading Cellca Cell Line Development with a co-developed, fully optimized cell culture media system, cGMP cell banking and characterization, and protein characterization services to create the integrated CHO Platform for protein-based therapeutics. With the freedom to use the CMO of your choice, you can rapidly progress from DNA to master cell bank (MCB) and overcome typical obstacles that can delay manufacturing a first GMP batch.
This Unique Cell Line Development Technology Platform Combines 4 Key Components
- Expression Vector
- Host Cell Line
- 4Cell® Media System
- Upstream Process Design
Identify High-Quality, Antibody-Secreting Clones with Proven Processes
Cellca Cell Line Development is an accessible, scalable, and robust system that delivers a product from DNA to fully characterized research cell bank in just 14 weeks. This unique cell line development technology combines four key components — expression vector, cell line, media system and upstream process design — to deliver high-yielding, stable cell lines and robust, simple, fed-batch processes for the biopharmaceutical market.
- Predictably high protein productivity 3-8 g/L
- 3 or 4 stable clones for steadily high-performing cell line
- Expression vector developed and optimized together with CHO DG44 host cell line to deliver the best possible results
- Supported by a team of experts: more than 220 CLD projects; over 120 cell lines developed
Assure Product Quality from the Start with Comprehensive Characterization
Sartorius helps preclinical and clinical developers advance drug candidates from early-stage development to commercialization by offering a complete biologic characterization solution. This solution consists of purpose-built instrumentation platforms and pre-validated, off-the-shelf assays, as well as custom assays to meet the characterization challenges of increasingly complex biological therapeutics. That, combined with access to industry experts, saves valuable time and resources, leading to a robust data package that will guide success in every phase.
- Guide clone selection to impact product quality
- Receive early characterization data
- Develop critical custom potency assays that will be required for the lifetime of the product
Ensure Secure Cell Bank Manufacturing with Sterile, Single-Use Solutions
The Sartorius CHO cell banking platform was developed specifically for the Cellca Cell Line Development (CLD) platform. Seamless transition from CLD to master cell bank (MCB) & working cell bank (WCB) manufacturing occurs via an integrated service approach. By combining cell banking with CLD services, a project can move from plasmid DNA to final released MCB in less than 10 months.
- Rapid filling of 500 vials @ 12 M cells/vial for MCB manufacturing
- Fully GMP-compliant cell banking platform
- Qualified Person (QP) MCB | WCB release
Save Development Time With Ready-to-Use Testing Packages
Sartorius offers a broad range of services to characterize your mammalian cell banks in accordance with ICH regulatory guidelines (ICH Topic Q5 Quality of Biotechnological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products). Sartorius also offers a comprehensive portfolio of test methods to ensure your product batches are free of contaminants throughout the program lifecycle.
- Compliant with global pharmacopoeial standards
- Performed in facilities accredited by the UK MHRA, adhering to EU GMP and audited by USA FDA
Optimized CHO Media for Easy Scale-up to Commercial Production
Sartorius has developed a portfolio of high-quality and high-performing cell culture formulations for CHO cell lines, which are chemically defined, serum-free and free of animal components. The 4Cell® Media Systems perform best when combining the production medium with its dedicated feed additives, which provide optimized conditions to CHO cells throughout the fed-batch culture.
- Designed for high cell densities (up to 4x107 cells/mL)
- Supports fast cell growth, consistent performance and robust scalability
- High productivity of protein, obtaining up to 8g/L when combined with Sartorius Cellca cell lines