Stable Cell Line Development Service

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Through the world-class services of Fusion Antibodies and our partners we deliver robust, high yield and flexible stable cell lines in rapid timelines.

Fusion Antibodies are an experienced partner in developing stable cell lines for research and manufacturing purposes. We can offer you an integrated solution for your biopharmaceutical development from optimization, to stable cell line development and cGMP manufacture. Centered on our stable cell line development service we can offer complete supply chain management to accelerate your therapeutic or diagnostic antibody towards the clinic.

Here is how we can realize your vision;

 

Antibody optimization

In addition to our discovery services we can humanize, optimize and risk mitigate your protein of interest with our Antibody Developability and Manufacturability services. We perform this work in-house to seamlessly build it into your stable cell line development strategy.

Stable cell line development

With flexible capabilities we develop cGMP-ready stable cell lines in a variety of host cell lines to meet your cost, timeline and licensing needs. Using our preferred CHO K1 CHOvolution cell line to make the stable constructs, development is initially carried out in our GLP facility, before research cell banks are transferred (if instructed by you) to your chosen CDMO. We do also provide options for cell line development in the Invitrogen/Thermofisher DG44, CHOS and HEK293 systems.

Supply Chain Management

Fusion Antibodies have developed strong alliances with several CDMO partners to facilitate the seamless success of your project. By working with Fusion Antibodies you will have no obligation access to our carefully selected world class CDMO partners and avail of accelerated timelines resulting from our established working relationship. Flexible subcontracting arrangements.

We offer two main cell line development options; Manufacturing cell lines & Stable pools, more details are provided below

Why Fusion's stable cell line development service?

Our breadth and depth of technical knowledge, experience and supporting services are what you need to realize your vision.

  • Open and flexible approach to business and project planning.
  • Proven, reliable biologics manufacturing services (antibodies and non-antibody proteins).
  • CHO K1, CHO DG44 and HEK293 capabilities.
  • World class facility with complete project isolation, redundant power systems and cutting-edge technologies.
  • Suite of supporting services including Antibody Analysis Services, Antibody Humanization and cGMP manufacturing through our partners.
  • Reduced cost, reduced timelines and increased flexibility by developing your cGMP cell line in a GLP lab with full regulatory support.

 

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Contact us about Cell Line Development Services

 

Seamless transfer of final clones to CDMO for further development

We know our clients value simplicity and we strive to make that happen.

Fusion Antibodies has established partnerships with several CMDOs to allow a seamless tech transfer process in parallel with development of your cell line. No time is lost during the transition as Fusion Antibodies work to the standards of our cGMP partners to simplify your tech transfer process.

We offer two tiers of cell line development services

We follow optimized and tailored workflows to meet your requirements and realize your vision. Our manufacturing cell lines are perfect for taking recombinant proteins to the clinic and our research cell lines suitable for reagent antibodies, research antibodies and diagnostics. 

Manufacturing cell lines

We get your therapeutic antibodies to the clinic faster.

Our manufacturing cell line process employs, extensive high throughput screening of clones, extended stability studies, detailed characterization in batch cultures, multiple cell banks and more to deliver the best possible cell line. At Fusion Antibodies we manage risk by combining our cutting edge services, support and unrivalled experience to achieve project success. 

Key Features

  • We meet the FDA/EMA standards with fully traceable documentation on the generation of the cell line including a final report and TSE/BSE documentation.
  • CHO K1, CHO DG44 and HEK293 systems available.
  • Royalty free.
  • Ability to achieve titres upward from 2g/litre to 8g/litre (with an inverse reduction of downstream cost with increase in titer).
  • Robust and scalable system from 1 to 1,000 litre bioreactors. Proven stability over 120 generation cycles and easily scaled up to 1L, 50L, 200L and 100L scales with Phase I to market supply options.
  • Competitive timelines.
  • Analysis of the manufacturability of the cell line from an early stage.
  • Continual monitoring of the quality of antibody expressed by a multitude of methods, e.g. SEC/HIC analysis.
  • Seamless transition from our GLP manufacturing site to our cGMP partner companies.

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

Stable pools & 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 characterization work or other small research projects; expression from stable pools is the perfect solution for supply of purified protein in the order of 1mg to 1g.

Our stable pool development process is identical to the first two stages of our manufacturing cell line development project, which means if/when you require a manufacturing cell line for clinical applications, Fusion Antibodies can pick up from where we left off.

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

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