Cell Line Development (CLD)Analytical Method DevelopmentFormulation DevelopmentProcess Development and Manufacturing

Cell Line Development
(CLD)

Highly productive cell lines delivering safe and effective products

Generation of early-stage product from fast stable pools enables us to confirm the Quality Target Product Profile (QTPP). In parallel, this material can be used to initiate formulation and analytical method development, taking these key activities off the critical path. Material from stable pools can also help accelerate process development for ADCs. 

We have developed multiple cell lines which have progressed from process development into manufacture and through clinical trials. With years of experience in cell line development (CLD), our team has successfully expressed biologics including antibodies, antibody fragments, bispecific antibodies, fusion proteins, growth factors and vaccines.

For molecules such as mAbs, Fabs and Fc fusions, we minimize timelines using our standard platform methodology. For novel and complex molecules, we design and develop a rapid, robust approach to your program. 

Our fully integrated, proprietary and license free offering allows us to accelerate timelines and de-risk development in your CLD programs, enabling rapid delivery of productive cell lines.

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Our Integrated Approach

We have an integrated approach which shortens timelines to IND enabling material supported by using fast stable pools to generate early-stage material for characterization, pre-formulation, analytics and lead molecule selection.

We do this through:

  • Fast development of high-quality clones for manufacture
  • Platform processes for rapid progression through process development
  • Use of widely available commercial media and feeds for easier transfer
  • Strong analytics and bioassay capabilities to ensure product quality as well as productivity
  • Global project management to ensure the smooth progression of projects for on-time delivery

ABZ- CHO-K1

ABZ-CHO-K1 offers:

  • Serum free, suspension adapted CHO cells
  • Well documented history of ABZ-CHO-K1 cell line including Research, Master and Working cell banks
  • Optimized proprietary vectors to maximize gene expression
  • One cell line for a product’s entire lifecycle, from development through to commercial manufacturing
  • Highly productive, fast stable pools within 5 weeks of transfection for production
  • Purified early-stage material for formulation and analytical method development, reducing development timelines
  • High throughput clone screening to rapidly identify highly productive clones
  • Quick, reliable process to generate clonal RCBs within 16 weeks of transfection
  • Rapid progression of RCBs through process development to GMP scale-up to provide IND enabling material

Abzena’s CLD technology can be used to switch host cell platform from older originator cell lines (i.e., NS0 and Sp2/0) to ABZ-CHO-K1.

We can help you maintain biosimilarity, critical for the regulatory approval of biosimilar products, by developing your cell line using the originator cell type. We have access to a range of CHO, NS0 and Sp2/0 cell lines adapted to serum-free growth media.

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Cell Line Development for Biosimilars

Our experts de-risk your project by providing additional product quality assessments to ensure that the Quality Target Product Profile (QTPP) is on track to match originators. Additional early upstream process development can be performed using 15 or 250 ml multi-parallel robotic bioreactor systems to better match originator CQAs.

Whether you decide to stay with the originator or switch to a new host cell line, Abzena can advise on strategies for clone selection, process development and comparability studies to demonstrate that critical quality attributes affecting efficacy and safety are maintained.

We offer comprehensive analytical and bioassay packages to support clone selection minimizing process development time.

We can help you maintain biosimilarity, critical for the regulatory approval of biosimilar products, by developing your cell line using the originator cell type. We have access to a range of CHO, NS0 and Sp2/0 cell lines adapted to serum-free growth media.

Vaccines

Applying our platform technologies and extensive experience in proteomics, protein engineering, bioconjugation and formulation development, we design novel subunit and conjugate vaccine candidates.

Underpinned by our analytics capabilities, protein expression, scale up and manufacture services we ensure that your vaccine is successfully delivered to IND for clinical trial evaluation.

Other Cell Lines

We have the flexibility and expertise to apply our processes to other proprietary host cell lines to support your program.

For example:

  • SP2-0
  • NS0
  • PER.C6
  • CHO-ZN
  • CHO BIOP3

Research Cell Banking

From transfection pools or non-clonal cell lines we apply our robust single cell cloning process to rapidly isolate and identify the most productive monoclonal populations.

Our services include:

  • Single cloning step for rapid generation of monoclonal populations
  • High statistical probability of monoclonality with visual images to provide documented assurance
  • Integrated product quality assessment included in clone selection
  • Storage in validated auto-fill liquid nitrogen Dewar with an independent validated monitoring system with a 24-hour call out.
  • Back-up cryo-storage capacity is permanently available, ensuring a robust and reliable service.

Characterization

The safety and quality of your biological products starts with the right cell line.

Clones are selected based on productivity and its performance in the bioreactors including product quality assessments that are tailored to your needs.

Our standard product quality testing includes sterility, mycoplasma, cell identity, gene sequences, and stability.

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From bench to bedside, we are dedicated to ensuring quality excellence in everything we do.

We adapt our approach to shorten lead times and develop risk mitigations strategies to ensure your overall success in delivering vital medicines to patients.