CHO Platform for Biopharmaceutical Cell Line Development

Bundled CLD, Cell Banking, and Testing Services for Protein Expression

Development of new protein therapeutics is a complex process, with technical and regulatory hurdles to overcome on the path to commercial success. Drug developers need to focus on speed, performance, and quality to outpace the competition, which is why we’ve put together a reliable single-vendor solution to get you from DNA to a cGMP master/working cell bank. The Sartorius CHO Platform combines Cellca cell line development services, fully optimized cell culture media, protein characterization services, cell banking, and biosafety testing into one cost-effective integrated solution from a single provider. Now you can accelerate your program without the hassles of multiple contracts and negotiations. Our unique platform reduces cost and delivers reliable results while maintaining an exceptional degree of flexibility.

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Predictable Performance

Our superior, scalable technology leads to high productivity (protein titers of up to 8 g/L) and high product quality.

Reliability

With the experience of 120 successful CLD projects in our portfolio and 14 years of technical and regulatory expertise, we can help you get it right the first time.

Reduced Time-to-Market

A proven platform enables a research cell bank in 14 weeks and a released master cell bank in less than five months, with no need for media/process optimization and scalability studies.

Reduced Risk

With one seamless process, from DNA to GMP cell bank, it's much easier to mitigate the risk of a cell line not meeting productivity or quality goals.

Financial Advantages

Save money with our bundled offering. With the Cellca CLD service, you pay no royalties or milestone-dependent fees, removing licensing or partnering barriers.

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Fast Track to IND — With Uncompromised Quality

The CHO Platform service package: Simplifying the Journey from DNA to cGMP MCB

Sartorius has simplified cell line development with the CHO Platform, combining the industry-leading Cellca cell line development services with a co-developed, fully optimized cell culture media system, protein characterization services, cGMP cell banking and biosafety testing into one offering. With the freedom to use the CMO of your choice and the simplicity of a single vendor, you can rapidly progress from DNA to master cell bank without the typical obstacles, such as multiple negotiations and contracts, that can delay manufacturing a first GMP batch.

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Generation of stable production cell lines with high yields and the right product quality

The unique Cellca cell line development service combines 4 key components:

  1. Expression Vector
  2. CHO DG44 Host Cell Line
  3. 4Cell® XtraCHO Media System
  4. Upstream Process Design

Together, these components deliver high-yielding, high-quality, stable cell lines and robust, simple and scalable, production processes for the biopharmaceutical market within 14 weeks (DNA to RCB)

  • Predictably high protein productivity (up to 8 g/L)  
  • 3 or 4 stable clones for steadily high-performing cell line  from each CLD project
  • Expression vector developed and optimized together with CHO DG44 host cell line to deliver the best possible results
  • Supported by a team of experts

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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

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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

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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  

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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, protein- and peptide-free and free of animal components. The 4Cell® Media System performs 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 productivities, obtaining up to 8 g/L when combined with Sartorius Cellca cell lines  
  • Supports fast and high cell growth (up to 4x107 cells/mL), consistent performance and robust scalability

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CLD Service Webinar - Valuable Insights Followed by a Lab Tour

Learn about the technologies and processes used to produce consistent high quality CHO clones that produce industry relevant titers and high-quality proteins.

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Related Products

Brochure

CHO Platform Service Package: The Fast Track to IND

PDF | 1.5 MB
Datasheet

4Cell® XtraCHO Media System

PDF | 598.3 KB
Application Note

A Multi-Scale Approach to CHO Media Benchmarking

PDF | 371.9 KB
Application Note

Consistent Performance of 4Cell® XtraCHO Media System in Flexsafe® Bags

PDF | 882.1 KB
White Paper

Cell Growth Performance in Single-use Bags

PDF | 1.3 MB
Article

Improving the Overall Efficiency of Cell Line Development

PDF | 4.2 MB

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