15:00 – 15:30 – Manfred Saller, Bioceros

Application of LabChip technology for biosimilar MAb development

Bioceros BV has used its proprietary CHOBC® platform and novel SPOT™ technology to generate a portfolio of high-titer cell lines (3-6 g/L) for the production of both biosimilar and novel monoclonal antibodies (mAbs).

Cell line generation includes extensive screening efforts and the best performing clones are passed on to the up- and downstream process development departments. We developed a USP toolbox to modulate all key CQAs and our in-house DSP capacities enable us to develop scalable, high-yield and low-cost processes.

For all these steps the availability of high-throughput screening capabilities is crucial. Charge distribution and product purity/integrity are two important quality attributes, which are widely monitored for projects in research as well as development stages. To this end, the LabChip technology (Perkin Elmer) is applied for CZE and µCE-SDS analyses in our laboratories and examples thereof will be presented in this talk.

About Manfred Saller

In 2006 I received my Master’s degree (Microbiology) from the University of Regensburg (Germany) on the isolation and identification of (membrane) proteins from hyperthermophiles. My dissertation was carried out at the RUG (Rijksuniversiteit Groningen, the Netherlands) with focus on the functional analysis of membrane protein insertion. After my PhD defense in 2011, I worked for 1.5 years as postdoctoral fellow at the Institute for Polymer Chemistry and Bioengineering of the RUG employed as group leader of the ‘biology team’. Our main tasks embraced production and purification of (membrane) protein complexes, peptides and DNA for material science purposes.

Subsequently, I held a DSP Specialist position for 3.5 years within Synthon Biopharmaceuticals (Nijmegen), at which I was involved in DSP process development for monoclonal antibodies (mAbs)and antibody-drug-conjugates. Since March 2016, I am responsible for all DSP-related activities within Bioceros BV (Utrecht) as Director DSP. My team’s main tasks are the development of DSP processes for biosimilar and novel mAbs.