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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.
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:
ABZ- CHO-K1
ABZ-CHO-K1 offers:
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.
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.
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:
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:
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.
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.
