Protein Engineering: What It Is and How It’s Improving Patient Outcomes

What is protein engineering?

Protein engineering is the cutting-edge science of modifying proteins to make them more useful, often in a medical context. Because proteins are such powerful biological tools, the ability to change and improve them expands their horizon of uses and pushes the boundary of the biotech field. By harnessing the full power of proteins, it is possible to create unique opportunities to restore quality of life for patients suffering from previously incurable conditions.

In practice, protein engineering often involves taking a naturally occurring protein and changing it to enhance its most valuable characteristics, or to introduce completely new properties. In the lab, proteins can be tailor-made to treat disease or damaged tissue by improving efficacy and safety. For example, Theradaptive uses an innovative computational process to create and identify recombinant protein variants that are able to bind to and coat a medical device or injectable carrier. This way, therapeutics can be more precisely delivered to the area that is in need of treatment, improving efficacy and reducing off-target effects in a range of indications from spine to oncology.

How does protein engineering work?

Scientists use two primary methods of protein engineering to achieve the end goal of creating therapeutics that overcome limitations in delivery, localization, pharmacokinetics, and bioactivity. A protein sequence may be adapted via rational design, or via library selection, or a mixture of the two.

Of the two protein engineering techniques, rational design uses knowledge of an existing protein’s function and structure to predict the effect of mutations on the protein’s properties. A computer is used to spatially model the protein so that new recombinant variants subsequently can be created using techniques like site-directed mutagenesis. Simply put, one amino acid is replaced with another in a way that is likely to create more beneficial properties.

The main stumbling block to rational design is that knowledge of protein structures can be limited, meaning they are difficult to model. As an alternative method for protein engineering, library screening does not require such detailed understanding. This technique involves a process of accelerated natural selection to discover new protein variants from a large library of variants, but in a matter of days and weeks rather than over millennia. The natural biological processes of mutagenesis and recombination of DNA are accelerated to select the desired properties for the protein’s new function.

What is protein engineering used for?

Protein engineering is revolutionizing a range of industries, from food to biofuel to pharmaceuticals, and it promises to be particularly transformative in biotech and medtech. To name just a few applications, protein variants can be created specifically to have antiviral properties, tissue regenerative properties, or material binding properties. With an aging population and a desire to push the boundaries of medicine ever further, biotech innovations that rely on protein engineering will allow physicians to offer more targeted and efficacious treatments.

While Theradaptive is currently the furthest along in the development of engineered proteins to improve outcomes in spinal fusion and long-bone repair, the principle of using protein engineering to create material binding variants also promises to transform oncology, novel vaccine development, wound healing, and nerve and vascular repair, among others. Protein engineering is a relatively new field. The advances that are still to be made are nearly limitless and we are just scratching the surface.

To give a sense of the massive potential for new therapeutics using protein engineering, the number of galaxies in the observable universe is estimated at two trillion, or ~10¹². The number of different protein variations that are possible in a protein that is 100 amino acids long is 10¹³⁰. This is 10¹¹⁸ times greater than the number of galaxies in the observable universe.

How do researchers mass-produce a protein through genetic engineering?

Once a protein with useful properties has been engineered, the next step is to produce it in large enough quantities for wider use, or at least to start the clinical trial process.

This is done using a technique called recombinant DNA technology. The gene that codes for the production of a useful protein is designed and synthesized. Next, this gene is cloned into a cell line that can produce large quantities of the protein. This protein is then purified and able to be used for R&D or as a therapeutic.  When used for human clinical trials the production process must be performed under Good Manufacturing Process (GMP) standards. This is the process by which Theradaptive’s proprietary implant binding-variant proteins such as AMP2 are currently produced.

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