Trusted Cell Line Development Services that Expand Your Capabilities and Speed Time-to-Clinic
Get It Right The First Time
High-performing stable production cell lines are essential for the successful manufacturing of biopharmaceuticals. Sartorius’ reliable CHO cell line development services minimize your risk and timeline, maximize the performance of your cell line and save your resources. Benefit from Sartorius’ leading CHO cell line development technology and the experience of more than 120 successful cell line development projects.
More than 240 successful cell line development projects. Benefit from our know-how and experience and get your cell line right the first time.
Proprietary and superior CHO cell line development technology that ensures a robust and scalable bioprocess with high product yield (> 5 g/L for monoclonal antibodies) and quality.
From DNA to Research Cell Bank (RCB) in only 14 weeks. No need for time-consuming media and process optimization or scalability studies. Regulatory ready package of assays.
Sartorius is adapting to your needs. Choose between individual services or complete bundles to accomplish the whole range from DNA to regulatory compliant GMP cell banks.
From DNA to GMP cell bank with only one vendor. Optimize outcome, resource and project management by minimizing coordination efforts, project time, and financial investments.
Here For You From The Start
Sartorius’ Cell Line Development Services are available at every step of the process with bundles and solutions to meet your needs. Derisk your decision making and let our knowledgeable team with over 14 years of experience expand your capabilities.
CHO Platform Service Package
The CHO Platform Bundles Individual Services into a GMP Manufacturing-Ready Service
The combination of Sartorius’ industry-leading technologies and services into one integrated solution accelerates your program and put your molecule on the path to success.
The unique CHO platform service consists of the 5 different Sartorius solutions:
- CHO cell line development service
- 4Cell® cell culture media
- Protein characterization service
- Cell bank service
- Biosafety Testing service
The package offers reduced cost and proven results while maintaining an exceptional degree of flexibility. With the freedom to use the CMO of your choice, you can rapidly progress from DNA to GMP cell bank (MCB/WCB) and overcome typical obstacles that can delay manufacturing a first GMP batch.
Discover CHO Platform Service Consult Our Experts
Cell Line Development Service
Sartorius’ Unique CHO Cell Line Technology Delivers High-Yielding And Stable Cell Lines
Sartorius’ CHO Cell Line Development service targets commercial manufacturing of biopharmaceuticals.
Our unparalleled Cellca cell line development technology combines 4 key components:
- Expression Vector
- Host Cell Line
- 4Cell® Media System
- Upstream Process Design
Together, these components deliver stable cell lines with high product yields and quality as well as and optimized, robust, simple, and scalable bioprocesses for the biopharmaceutical market. Our CHO Cell Line Development service is easily accessible, and delivers a product from DNA to research cell bank (RCB) in only 14 weeks.
Provide us with your DNA and in 14 weeks, receive a RCB with high product titers (> 5 g/L for monoclonal antibodies) in an easily scalable bioprocess.
- Well-characterized CHO DG44 host cell line with documented history
Save up to 3 months by skipping media & process optimization as well as scalability studies.
Scalable Protein Characterization Services
Shorten your timeline with our pre-qualified assay panels
Sartorius’ protein characterization services are scaled to each phase of drug development. These services include development, qualification and validation of product characterization assays, such as cell-based potency assays, binding assays and physicochemical tests. Our panel of assays have been pre-qualified with commercial monoclonal antibodies and can shorten analytical development timelines.
The range of analytical testing services Sartorius offers is backed by a team of scientists with years of technical and regulatory experience.
Sartorius offers cost-effective, ready-to-use, and customizable cell-based and binding assays contribute to the comprehensive characterization of your product.
Ready-to-use Assay Solutions for Immuno-Oncology
An Analytical Immuno-oncology Toolbox for Checkpoint Inhibitors is comprised of a series of platform methods and ready-to-use solutions to accelerate drug development with the CHO Platform.
High-Quality Mammalian Suspension Cell Banks
Sterile, Single-Use Solutions Using Automated Filling, Producing Cell Banks
The Sartorius cell banking platform was designed as a closed, sterile, single-use system with automated filling into vials to generate large banks. Our custom cGMP cleanroom facility located in Newhouse, UK is fully dedicated to mammalian cell lines in suspension. Serum-free, animal component-free media are used to produce cell banks for use in protein and viral manufacturing applications. This closed manufacturing system is fully nutrient-broth qualified to provide added process safety and assurance of sterility.
Sartorius has extensive experience in single-use technologies, as well as relevant technical and regulatory knowledge to support cell banking.
Integrated offering with the latest technology solutions for high-quality cell banking.
- Dedicated cGMP licensed facility
- Standard >500 vials, 12e6 viable cell / cryovial
- Closed and automated single-use process
- Rapid FILL-IT automated fills over 500 vials within 20 minutes
- Validated controlled-rate freezing
- Process Certified broth qualified for sterility assurance
- Qualified Person (QP) batch release
- Flexibility of transfer to any CMO for product manufacture
Face Regulatory Challenges Head-on With our Characterization Services ...
Support the Testing and Release of Cell Banks for Use in Manufacturing Programs With Ready-to-Use Quality Control Panels
Sartorius has extensive experience in characterization of cell banks used in production of biologic drugs for protein-based therapies.
Sartorius’ QC testing plans meet requirements for mammalian cell bank release and are designed to meet ICH Q5A regulations with assays validated to GMP standards. Ready-to-use testing schemes may be added to existing Drug Development Risk Strategies or customized for the needs of specific programs. With a safety profile established over 20 years, CHO cells are by far the most used production cell lines in the pharmaceutical industry. Sartorius has performed biosafety and characterization testing on over 200 CHO cell banks. Our scientists have a wealth of experience to advise on the most appropriate and cost-effective testing strategy to meet regulatory requirements.
We offer developers early characterization data to help guide the selection of the final clone. Our predefined package of testing covers the aggregation and charge variant profile, the n-glycans, peptide mapping, intact and reduced mass. These standard techniques are complemented by custom target binding by SPR and FcRn binding. Our ready to use methods have been extensively qualified using standard monoclonals, and our platforms offer demonstratable reduction in development time.