Originator Cell Line Development - Abzena

Stable Cell Line Development with Composite CHO™

License free mammalian cell line development platform with in house analytics and fast track to manufacturing

Abzena has over 10 years’ experience in cell line development with its own proprietary cell line, Composite CHO™. With over 50 cell lines developed, expressing biologics ranging from antibodies to fusion proteins, Abzena is your perfect partner for progressing your project through to manufacture and clinical trials.

Abzena’s Composite CHO™ platform technology combines the following features:

  • Licence, royalty and milestone free Composite CHO™ cell line
  • High expression levels (3-5g/L)
  • Accelerated timelines with POC material in 10 weeks and RCBs in 6 months
  • Compatible with commercially available production media and animal component free
  • Access to on-site analytical testing/PQA and bioassays throughout the process
  • Assurance of monoclonality and virus free
  • Modular approach to facilitate smaller customised projects
  • Stable expression for more than 60 generations

Selection of lead molecules

Abzena can generate POC material from stable pools for multiple product candidates in just 10 weeks. Material can be assessed utilising Abzena’s analytical and bioassay expertise to help clients select the favoured candidate for further development to monoclonal RCBs in just 4 months.

Improved confidence for difficult to express proteins

Abzena have a long history of producing cell lines where others have failed. It is through having expert bioanalytics and bioassay teams in the same building that we are confident during early clone selection that we are producing the right material. With the experience to convert these into high expressing cell lines.

Analytics at each key stage

As well as developing high yielding, robust manufacturing cell lines Abzena’s unique approach incorporates product quality analysis at key points during clone selection to ensure that both product quality and productivity targets are hit. Embedded analytics personnel in Abzena’s cell line development teams provide expert guidance throughout development.

ambr® system optimisation

Upstream productivity is a key consideration when choosing a cell line. Abzena’s use of the ambr® system allows us to mimic the characteristics of classical bioreactors at microscale (10-15ml), enabling the rapid evaluation of multiple bioreactor cultures clones in bioreactor conditions to select peak performers. Abzena uses the same system to scales up to 2,000L scale, to ensure reproducible results.

Speed to clinic with integrated manufacturing

Abzena’s Cambridge, UK CLD group and San Diego, CA manufacturing facility work hand-in-hand to ensure the smoothest transition of RCBs to enable an accelerated process. Abzena’s manufacturing team are extremely familiar with the Composite CHO™ cell line and can start upstream process development months before it would be possible with an external CMO.

Deliverables

Whilst Abzena specialize in taking your project from cloning through to GMP development, we are also happy to work with partners on smaller projects. The table below give some example modules and timelines, we are also happy to configure customised modules to suit your project needs.

 

 

shutterstock_143646112Working with Abzena

Abzena’s cell line development services are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results.

To get more information, a quote or to schedule a teleconference please contact us.

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