Bioprocessing Symposium: Proven Tools, Measurable Results

Regeneron is on a journey to develop the upstream “Bench of the Future” by strategically and systematically implementing automation technologies. The “Bench of the Future” will advance process development capabilities, increase process consistency, improve workforce efficiency and quality of life, and offer flexibility to meet unknown future process needs.

A key goal of this project is to automate the daily at-line bioreactor sampling, which accounts for roughly 15% of the manual labor required to complete a benchtop bioreactor run. In addition to increased efficiency and labor savings, in-line and automated analysis of cell culture samples enables greater process control than traditional manual at-line analysis. This presentation will discuss the implementation of an autosampler into the broader “Bench of the Future” and the enhanced process monitoring, characterization, and control enabled by this benchtop autosampler technology.

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 John Czukkermann – Process Development Engineer I, Regeneron

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This study evaluated the performance of Aero-Yield single use flasks (SF) versus commonly used labware (Corning, Thomson, Enzyscreen) for two CHO derived cell lines: C5789A (manufacturing clone) and FUT8 2 (transfection pool).

Cultures were sampled thrice weekly (M/W/F) and analyzed for viability and viable cell density (VCD) using Vicell Blu, daily binding activity by Octet, and harvest titers by HPLC; metabolites (glucose, lactate, NH4+, osmolality) were also measured by NovaFlex. Aero-Yield SF generally produced higher VCDs and increased titers for both the clone and the pool compared with the baseline Corning 125 mL platform.

Viability and metabolite trends were broadly similar across labware, and no negative growth signals were observed. Additional SF sizes, specifically 125mL, have been requested for high-throughput culture screening applications, such as Cell Line Development. Further studies are underway to evaluate clone-labware rank order correlation with Ambr bioreactor performance.

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Victoria Mander – Senior Scientist, Cell Line Development, Johnson & Johnson Innovative Medicine

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This study will discuss the use of biocapacitance in the upstream process for manufacturing AAV via transient transfection. Biocapacitance helped solve issues related to accurate cell counting and standardize the transfection process for robust and consistent productivity. With the use of biocapacitance as an online PAT tool, batch productivity across multiple scales was increased while also improving the repeatability of the performance.

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Alex Vaca – Senior Engineer II, Biogen

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The current study evaluated Stellion Bio (4Bio) BioCore turbidimetric IgG titer determination versus a commonly used IgG titer method, biolayer interferometry (BLI, Gator Bio).

IgG samples of various concentrations ranging from 5 mg/mL to 5 µg/mL were prepared from Human IgG Isotype Control (Novus Biologicals) diluted with Q Buffer (Gator Bio). Each sample was measured n=6 times with each technique to demonstrate repeatability. The high content (hc IgG) and the high sensitivity (hs IgG) kits were used for the BioCore to demonstrate the advantages of each. Repeated measures on the same instrument, for both techniques, proved to have excellent repeatability with ≤20% Coefficient of Variation (CV) between measurements, while antibody titers across technologies was quite comparable, within a 25% CV.

The turbidimetric IgG titer determination method proved to be comparable to a commonly used technique, BLI. The availability of kits specific to high content (high titer) and high sensitivity applications broadens the range of available measurements. Both techniques offer simple assay setup and a very limited assay maintenance schedule.

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Matthew Ercolino – Head of Laboratory, Kyfora Bio

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