bioRxiv Science⌕ Search

bioRxiv · 10.1101/298273

Revolutionising the design and analysis of protein engineering experiments using fractional factorial design

Abstract

Protein engineering is one of the foundations of biotechnology, used to increase protein stability, re-assign the catalytic properties of enzymes or increase the interaction affinity between antibody and target. To date, strategies for protein engineering have focussed on systematic, random or computational methods for introducing new mutations. Here, we introduce the statistical approach of fractional factorial design as a convenient and powerful tool for the design and analysis of protein mutations, allowing sampling of a large mutational space whilst minimising the tests to be done. Our test case is the integral membrane protein, Acridine resistance subunit B (AcrB), part of the AcrAB-TolC multi-protein complex, a multi-drug efflux pump of Gram-negative bacteria. E. coli AcrB is naturally histidine-rich, meaning that it is a common contaminant in the purification of recombinantly expressed, histidine-tagged membrane proteins. Coupled with the ability of AcrB to crystallise from picogram quantities causing false positives in 2-D and 3-D crystallisation screening, AcrB contamination represents a significant hindrance to the determination of new membrane protein structures. Here, we demonstrate the use of fractional factorial design for protein engineering, identifying the most important residues involved in the interaction between AcrB and nickel resin. We demonstrate that a combination of spatially close, but sequentially distant histidine residues are important for nickel binding, which were different from those predicted a priori. Fractional factorial methodology has the ability to decrease the time and material costs associated with protein engineering whilst expanding the depth of mutational space explored; a revolutionary concept.\n\nSignificance statementProtein engineering is important for the production of enzymes for bio-manufacturing, stabilised protein for research and production of therapeutic antibodies against human diseases. Here, we introduce a statistical method that can reduce the time and cost required to perform protein engineering. We validate our approach experimentally using the multi-drug efflux pump AcrB, a target for understanding drug-resistance in pathogenic bacteria, but also a persistent contaminant in the purification of membrane proteins from E. coli. This provides a general method for increasing the efficiency of protein engineering.

Explore related subjects

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

Harborne, S. P., Wotherspoon, D., Michie, J., McComb, A., Kotila, T., Gilmour, S., Goldman, A.. 2018-04-16. Revolutionising the design and analysis of protein engineering experiments using fractional factorial design. https://doi.org/10.1101/298273

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related preprints

Material-driven fibronectin assembly enables low-dose BMP-2 to regenerate structurally mature bone in critical-sized load-bearing defects

Bone grafts for critical-sized load-bearing defects are usually judged by how much bone forms, and rarely by whether that bone is structurally and mechanically competent. Here, degradable ceramic monetites coated with poly(ethyl acrylate) (PEA) and functionalised with fibronectin (FN) and rhBMP-2 at 10-25 g/mL, 60-150-fold below the approved clinical concentration, are assessed across length scales. MicroCT showed that only monetites functionalised with rhBMP-2 bridged the defect, with a significant increase in new bone volume in both the monetite vicinity and the whole defect volume. In contrast, platelet-rich plasma (PRP) functionalisation significantly reduced bone formation relative to FN, showing that the identity of the adhesion cue, and not merely its presence, determines the outcome. Monetite degradation and increased interconnected porosity favoured bone ingrowth and produced a continuous interface between monetite and new bone. The multiscale analyses of quantitative polarised light microscopy, SAXS and nanoindentation show that PEA-coated monetites functionalised with FN and 25 g/mL rhBMP-2 promoted structurally and mechanically more mature bone, with a hierarchical organisation and local mechanical properties approaching those of native cortical tissue. In the bridged region this group recapitulated the preferential collagen fibre orientation of native cortical bone and reached an elastic modulus and hardness that were not statistically distinguishable from it, although mineral particles throughout the regenerated tissue remained thicker and less aligned than in cortical bone. Synchrotron microCT in an ovine model extended these findings to a clinically relevant scale, supporting the translational potential of the system. Taken together, these findings position PEA-coated monetites functionalised with FN and low-dose rhBMP-2 as a strategy for the structural and functional regeneration of large bone defects.

bioengineering↗

N-GLYcanyzer monitoring of a microperfusion process reveals critical parameters' impact on Trastuzumab biosimilar N-glycoform time evolution

Controlling monoclonal antibody (mAb) N-glycosylation as a critical quality attribute (CQA) remains challenging in continuous and intensified biomanufacturing, where conventional end-point analyses obscure dynamic pathway responses. Here, we deployed the N-GLYcanyzer process analytical technology (PAT) for automated monitoring of a microperfusion process that reveals critical parameters' impact on Trastuzumab biosimilar N-glycoform time evolution across a 20-day culture duration of Chinese Hamster Ovary (CHO) cells in a ~2 mL scale-down microbioreactor perfusion platform. Using offline PAT assays combined with our integrated at-line PAT workflow, we systematically screened six perfusion process parameters: carbon source, viable cell density (VCD), perfusion rate, temperature, and pH. While nutrient limitation and thermal/acidic stress significantly disrupted N-glycans maturation, notably triggering high-mannose (Man5) accumulation and severe productivity penalties under pH 6.7 and 39 {degrees}C operation, targeted feed supplementation with galactose and MnCl2 consistently shifted glycoform profiles away from G0F toward galactosylated species (G1F, G1F', G2F). Crucially, coupling this combined feed strategy with an intensified perfusion rate (1.2 VVD) achieved a sustained, desired galactosylation shift without a productivity cost. These findings demonstrate that nutrient feed composition and perfusion rate are primary levers for steering continuous intensified microperfusion processes for biologics production with desired N-glycoform states and highlight the utility of automated at-line PAT like N-GLYcanyzer for enabling real-time attribute-based control in continuous biomanufacturing.

bioengineering↗

Differential sensing with imprinted and non-imprinted organic electrochemical transistors reduces calibration drift in wearable sweat cortisol sensors

The output of a wearable cortisol sensor drifts over days for reasons unrelated to cortisol, so a calibration made on the first day soon stops being valid. In our differential organic electrochemical transistor, a PEDOT:PSS transistor coated with a molecularly imprinted polymer (MIP) for cortisol is paired with one coated with a non-imprinted polymer (NIP) of the same composition, and the NIP response is subtracted. Over four calibrations in artificial sweat across 14 days, the response of the MIP alone shifted by 15% to 22% of its range on day 1, whereas the differential output shifted by 1% to 10%, and the variation between days at 1 to 10nM fell by 65% to 70% on average for individual pairs. In sweat from one participant, read against the calibration from day 1, both outputs tracked the direction of visible changes in salivary cortisol, while the MIP alone diverged from the differential output, consistent with the laboratory drift.

bioengineering↗