Friday, May 16, 2014

What We Can Learn From the MaxCyte Flow Electroporation

MaxCyte recently presented data demonstrating the reproducibility, scalability, and antibody production capabilities of their flow electroporation.  You’ll have to check out the full report to get all the facts but we were able to pick the brain of Krista Steger, PhD, one of the contributing authors, to get her take. 

What are the biggest implications you see from the data presented?
Our data have huge implications on the way biotherapeutic companies conduct antibody development.  Transient gene expression (TGE), and in particular CHO-based TGE, can play a greatly expanded role in antibody development, which has a positive bottom-line effect.  Multi-gram quantities of antibodies can now be produced from a single transient transfection enabling TGE usage not only for early phase candidate identification, but also for later stage pharmacology, stability, and manufacturability studies.  By reducing early reliance on stable cell line generation or HEK-based expression, development timelines and costs can be significantly reduced. MaxCyte systems are cGMP-compliant, clinical-grade, CE-marked instruments that have Master File designation U.S. FDA and are currently in use for FDA approved cellular therapy.  These plug-and-play instruments are computer-controlled and use single-use processing assemblies; all features that support their use in biomanufacturing.

What surprised you most about the data?
This data certainly reinforced our previous experiences of high CHO cell transfection efficiencies and cell viability produced using MaxCyte-optimized electroporation protocols, as well as the capacity to easily scale MaxCyte electroporation without sacrificing performance.  The literature suggested that there were a variety of post-transfection parameters which positively impact antibody production such as media additives and temperature shifting.  We were extremely pleased to reach the 1g/L mark following straightforward culture optimization which equates to an approximately 10-fold increase in antibody titers compared to the previously reported 10-100mg/L titers produced using lipid- or PEI-based transfection.

Are there any current issues in the field you see as pertinent to this?
Prior to MaxCyte electroporation, CHO transient transfection produced very low antibody titers which often lead researchers to use HEK-based transient expression.  Multiple reports have shown that there are differences in the manufacturability, affinity, and efficacy of antibodies produced in HEK cells compared to those produced by CHO cells.  By performing development work in a CHO-cell background, the continued manufacturing cell background of choice, using MaxCyte electroporation, companies can reduce attrition rates and focus resources on the candidates most likely to succeed.

Often times these studies raise even more questions.  Is there anything that comes to mind for you?
Our data represent a large step forward in the capabilities of CHO-based TGE.  We anticipate our clients, the true experts in antibody production, will push this system in terms of pre- and post-transfection culture parameters to its maximum to further streamline expression processes, increase production capacity. and reduce the time and costs associated with large-scale protein production.  This leads to the question – is the multi-gram antibody production capacity of MaxCyte-based transient expression large enough to replace stable cell lines for therapeutic biomanufacturing? 

Additionally, the studies reported in this paper demonstrate that MaxCyte flow electroporation is an extremely valuable tool for rapidly generating stable cell pools and cell lines.  These data suggest that by simultaneously implementing TGE for gram-scale protein production and the generation of stable cell lines, antibody development timelines can be significantly reduced.  The degree to which full implementation of this concurrent expression scheme can compress timelines and reduce costs is certainly a question of high interest.

You can download the full report from MaxCyte here.

We’ll have more on some of the latest protein studies at the Protein Aggregation, Stability and Solubility conference, June 4-6, San Francisco, CA.

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Bioconjugates: From Targets to Therapeutics

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