CHO Cell Line Development Service - DNA2RCB Service Package

Outsource your CHO cell line development program (partially or entirely) to Sartorius as your extended laboratory bench and trusted drug development partner. Select your service package from DNA2Pool (feasibility | manufacturability assessment), DNA2RCB (complete program up to research cell bank) and DNA2MCB (complete program up to GMP master cell bank).

CLD Workflow
Item No.: 
CHO-CLD-DNA2RCB
*Custom/bulk order quotes are provided within 72 hours of request.
CHO Cell Line Development Service - DNA2RCB Service Package
CHO Cell Line Development Service - DNA2RCB Service Package

Outsource your CHO cell line development program (partially or entirely) to Sartorius as your extended laboratory bench and trusted drug development partner. Select your service package from DNA2Pool (feasibility | manufacturability assessment), DNA2RCB (complete program up to research cell bank) and DNA2MCB (complete program up to GMP master cell bank).

Item No.:
CHO-CLD-DNA2RCB

Overview

Specifications

The DNA2RCB service package provides the complete cell line development program up to the delivery of the research cell bank (RCB), followed by performance assessment in bioreactors.

Our standard DNA2RCB approach delivers an RCB in 9 weeks* and includes:

  • Gene Synthesis: preparation of the sequence and DNA synthesis, followed by sequence confirmation.
  • Vector Cloning: cloning of genes into Sartorius’ expression vector, followed by sequence confirmation
  • Transfection & Pool Generation: vector transfection, large pool generation, and evaluation of three different construct pools in standard fed-batch cultures.
  • Clone evaluation: Ambr® 15 clone evaluation in 14-day fed-batch cultures.
  • RCB preparation and testing: top four clones selected based on cell growth KPIs and titer.
  • Delivery of 4Cell® SmartCHO media and feeds necessary for cultivation up to 3 L.

Top four clone stability studies and process confirmation in a 5 L bioreactor are then performed, and the full documentation package (including the single-cell cloning validation report) is prepared.

It is important to note that the scope of work described above is not exhaustive. Additional service packages (media and process optimization, process development, material production at pool and | or clone level, protein characterization, cell banking and biosafety testing) can be added and customized based on your needs upon request.

Please request a quote and contact our CHO cell line development experts to discuss how we can design a tailored project to fit your project and | or product requirements.

*For conventional monoclonal antibodies"

Applications

  • Application
    Clinical

General Specifications

  • CLD Service
    Outsourced
  • CLD Workflow
    DNA to RCB
  • Deliverables
    • RCB
    • Documentation
    • Performance Assessment
    • Stability
  • Drug Type
    • Biosimilars
    • New Biological Entity (NBE)
  • Molecule
    • Conventional mAbs
    • Bi- and Multispecific Antibodies
    • FC-Fusion Proteins
    • Non-Antibody Products