Biosimilar Cell Line Development - Abzena

Biosimilar Cell Line Development

  • Fully traceable CHO, NS0 or SP2/0 cell lines
  • Cell lines certified sterile and mycoplasma free
  • Enhanced product quality attributes assessment to compare to originator
  • Final optimised cell lines ready for cGMP manufacture

The process defines the product

An important decision in the development of biosimilars is the choice of cell line. Changing from the originator cell line can lead to changes in post translational modification, which can affect the characteristics of the product. The largest variations can occur in glycosylation patterns which have a significant effect on antibody dependent cell cytotoxicity (ADCC), half-life, stability and immunogenicity.

CHO, NS0 and Sp2/0 cell lines

Maintaining biosimilarity is critical for regulatory approval of biosimilar products and Abzena can help you achieve this by developing your biosimilar cell line using the originator cell type. We have CHO, NS0 and Sp2/0 cell lines adapted to serum free growth media available for development.

Product quality attributes (PQA) assessment

We have developed an approach whereby cell line and product quality are assessed at multiple stages as an integral part of the cell line development process to ensure that the product meets the required criteria. These assessments include:

Product integrity

  • Confirmation of full protein and subunit mass
  • Confirmation of subunit dissociation
  • Analysis for loss of subunit
  • Analysis of potential degradation
  • Confirmation of biosimilar concentrations

Product activity

  • Confirmation of binding characteristics
  • Confirmation of activity/functionality
  • Assessment of effector functions (ADCC/CDC) for antibodies

Product aggregation

  • Analysis of product aggregation
  • Intact mass analysis
  • Analysis of sample purity & confirm suitability of purification method

Product glycan profiling

  • N-glycan peak identification
  • Monosaccharide analysis
  • Sialic acid analysis
  • Fucosylation
  • Matching of specific glycan profile to innovator product

Quality Control testing

  • Full gene sequencing including full expression cassettes
  • Growth and productivity assessment
  • CFR21 compliant testing including mycoplasma, bacterial, fungal & viral sterility testing
  • Cell line identity test
  • Research cell bank viability and productivity assessment
  • Cell line stability to ensure productivity is maintained over multiple generations

Timeline

Abzena’s biosimilar cell line development projects take weeks and include extensive PQA testing throughout

Delivering on expectations

Efficient production is key to biosimilar development and Abzena has developed technologies, including Composite CHOTM and pDEX vectorsTM, to achieve high expression levels of desired antibodies and proteins. We ensure all materials we use to develop cell lines are free of animal-derived products and the cells are grown in a chemically defined medium. We have experience of transferring cell lines to GMP manufacturers and can transfer cell lines to our own GMP manufacturing facility in San Diego or to another facility.

 

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.

Immunogenicity Assessment

Antibody and Protein Engineering

GMP Manufacturing

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