Work packages

At-line measurements

The main objective of WP6 is to develop analytical strategies for at-line quantification of the most important cell culture and biopharmaceutical product attributes during bioreactor operation. This degree of process controls allows an effective feedback loop to maintain optimal reactor performance for maximum product titers and quality, while minimizing downstream processing requirements.

Within WP6, (1) Iprasense is developing an instrument allowing holographic lensless imaging to monitor cell density and viability; (2) Paia Biotech is developing multiple affinity assay architectures for the glycoprofiling of the target IgG product and (3) KTH is developing a multiplexed array of miniaturized sandwich ELISA assays to quantify several protein biomarkers in the cell culture supernatant such as host cell proteins and growth factors.

Both the glycoprofiling and protein quantification assays will be integrated in a microfluidic platform to maximize sensitivity, reduce reaction times and minimize total sample requirements.


Work package objectives:

  • Measure viable cell density using an holographic lensless imaging instrument.
  • Assess titers and glycan profile of the target product using appropriate lectin panels.
  • Multiplexed quantification of a panel of protein and nucleic acid biomarkers in the bioreactor namely lactate dehydrogenase (LDH), host cell proteins (CHO HCP), host cell DNA and growth factors.
  • Combine the glycoprofiling and protein quantification measurements strategies in an automated instrument resorting to microfluidic devices to expedite assay times using low sample volumes.
  • Validate the at-line measurement strategies for the continuous monitoring of bioreactors at cell- and supernatant-level.


Leader and co-leader

Aman Russom, Nanobiotechnology, KTH

Jens Traenkle, Bayer


Partners

KTH

Iprasense

Bayer

GSK

Sanofi

Paia Biotech

Micronit


Individual Scientists

Aman Russom, Nanobiotechnology, KTH

Inês Pinto, Nanobiotechnology, KTH

Ruben Soares, Nanobiotechnology, KTH

Geoffrey Esteban, Iprasense

Sebastian Giehring, Paia Biotech

Anna Johann, Paia Biotech

Jens Traenkle, Bayer

Stefan Klinker, Bayer

Elwin Vrouwe, Micronit

Melissa Hill, GSK