Cell Line Development

Optimizing the cell line development process without compromising quality to reach titers up to 10 g/L in 10 weeks.

 

Efficient and high-quality cell line and process development is the critical first step in the development of a robust manufacturing process for expression of a therapeutic protein.

FUJIFILM Diosynth Biotechnologies’ scientists have researched the key components in the generation of a recombinant cell line and, as a result, the next generation of our Apollo X™ mammalian expression system will produce a high quality recombinant cell line to take your biopharmaceutical from pre-clinical through to commercial production efficiently and rapidly. Apollo X is designed to be a ‘manufacturing-ready’ cell line with a robust support package to aid IND filing.

What are the main components of our Apollo X mammalian cell line?

Good science, experience and a quality driven approach.

Vectors

  • DHFR based selection system
  • Proprietary leader sequence developed for efficient secretion
  • High productivities achieved without the need for amplification
  • Codon optimization utilized
  • Double gene vector

Host Cell Line

  • It is a DG44 derived host cell line which was adapted to chemically-defined medium and suspension culture.
  • It was selected for superior growth characteristics and expression capability.
  • Fully characterized cGMP cell bank.

Cell Line Development Process

  • Maintaining a robust cloning strategy with one round of cloning through the application of the Cyto-Mine® system.
  • It is Animal component free media and reagents used for the entire cell line development process.
  • Product concentrations in excess of 10 g/L are typically seen using platform bioreactor conditions.

Media & Feed Optimization

  • New proprietary medium, specific for Apollo™, developed in-house by FUJIFILM
  • Ability to achieve high titers whilst controlling peak cell density and maintaining high cell viability.
  • Concept of continuous improvement with formulation knowledge

The combination of a new host cell line with the addition of an improved cell culture medium and process has allowed a reduction in cell line development time without compromising quality.

When can material be made available to feed other development stages?

We understand that material availability very early in the development process can be extremely beneficial to our customers. During our ApolloX Cell line Development work we want to make sure that we are able to support you with your material needs. Once Cell Line Development work has started, material can be made available at different stages:

  • From transfection to Research Cell Bank: 10 weeks
CHO

Why Choose CHO as an Expression System?

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To learn more about Apollo X click HERE