Stable Cell Line Development Service

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Fusion Antibodies is an experienced partner in developing stable cell lines for research and manufacturing purposes.

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Fusion Antibodies offer two adaptable stable cell line development products which allow maximum flexibility in reaching client expectations. All projects are performed to GLP standards and are delivered in a timely manner in agreement with regulatory compliance including documentation.

Fusion Antibodies have a strong alliance with cGMP partner Celonic (www.celonic.com) to jointly provide an expression system which is royalty free all the way to the clinic. Using the CHO K1 CHOvolution cell line to make the stable constructs, development is initially carried out here in our GLP facility, before research cell banks are transferred (if instructed by you) to Celonic for GMP production. We do also provide options for cell line development in the Invitrogen/Thermofisher DG44, CHOS and HEK293 systems. 

We primarily specialize in the development of stable cell lines expressing humanized antibodies but also Fc-fused proteins and a variety of cell surface receptors, cytoplasmic and secreted proteins.

Stable cell line development is important for:

  • Consistent high level expression of your protein of interest
  • Development of cell lines in serum free media to meet regulatory requirements
  • Expression of large functionally active multimeric proteins due to the presence of complex post translation modifications such as glycosylation and disulphide bond linkage
  • Ease of transfer of cell lines for cGMP scale production

We offer two main cell line development options; Minipool Development & Manufacturing Cell Line Development and more details are provided below

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Contact us about Cell Line Development Services

 

Our cell line development service key points:

cGMP banked cell line developed in GLP lab

Fusion Antibodies have developed the CHOVolution Cell Line development in collaboration with Celonic and are proud to offer the generation of high yield cGMP-ready cell lines in our world class GLP facility.

  • Reduced development costs
  • Reduced risk
  • Increased flexibility

Seamless transfer of final clones for Celonic for further development

CHOVolution allows a seemless tech transfer process in parallel with development of your cell line. No time is lost during the transition as Fusion Antibodies and Celonic work in close collaboration to transfer materials for initial DSP development in parallel with RCB generation.

  • Phase 1/2/3 supply
  • USP Development
  • DSP Development

The CHOvolution cell line and vectors are free from any royalty fees.

Maintiaing full IP and control of your cell line is critically important to Fusion Antibodies and Celonic.

  • All work is fee for service
  • No royalty fees for working with us or our partner Celonic

 

Stable minipools & Research cell lines

Fusion Antibodies offer a range of cell line development options which are flexible and adaptable to meet the specific requirements of your project. For smaller projects such as animal studies, PK studies, protein characterisation work or other small research projects; expression from stable minipools is the perfect solution for supply of purified protein in the order of 1mg to 1g.

Stable Minipool Development, is a lower cost option, ideal if you do not want to commit to a full manufacturing cell line development project and involves developing near-clonal minipools of cells in the Celonic CHO K1 CHOvolution system. Our stable minipool development process is identical to the first two stages of our manufacturing cell Line development project, which means if/when you did require a manufacturing cell line for clinical applications, Fusion Antibodies could pick up from when we left off.

We can also take this one step further and perform a limiting dilution to generate a "research cell line" which should have more clonality and higher expression.

For more information contact us using the form above, email info@fusionantibodies.com or call UK +44 (0)28 9043 2800

 

Manufacturing cell lines

Fusion Antibodies manufacturing cell line product is our top package for stable cell line development. Using the CHO K1 CHOVolution host cell line our manufacturing cell line employs, extensive high throughput screening of clones, two limiting dilutions required for FDA approval, extended stability studies, detailed characterisation in batch cultures, multiple research cell banks testing which will significantly increase your chance to find a stable cell line capable of multi-gram/L production in optimized conditions. 

Key Features

  • Based on CHO K1 system
  • Serum free suspension culture
  • Ability to achieve titres upward from 2g/litre to 7g/litre (with an inverse reduction of downstream cost with increase in titer).
  • Robust and scalable system from 1 to 1,000 litre bioreactors
  • Generation of a final clone in less than 12 months
  • Clone selection utilizing dual antibiotic selection
  • Analysis of the manufacturability of the cell line 
  • Continual Monitoring of the quality of antibody expressed by a multitude of methods, e.g. SEC/HIC analysis
  • Full post clone generation backup service including analysis of the clone stability
  • Fully traceable documentation on the generation of the cell line, final report, TSE/BSE documentation
  • Seamless transition from GLP manufacturing site to our GLP partner company Celonic
  • Access to expertise regarding worldwide authorities in particular FDA regulation

For more information contact us using the form below, email info@fusionantibodies.com or call UK +44 (0)28 9043 2800

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