$PBIO PreEMT™ Platform Enhances Development of Biotherapeutic Protein Drugs

• Biologics offer novel ways of treating degenerative diseases like Alzheimer’s
• Biologics are one of the fastest-growing drug categories
• PreEMT™ technology improves quality, reduces cost of biologic manufacture

When we think of drugs, an image of potions in round-bottom flasks conjured up in labs comes to mind, or perhaps pills of one sort or another ingested with a sip of water, for about 90 percent of drugs currently in use have that profile. However, discovering that the human body will act as its own physician by dispensing protective proteins called antibodies to fight the toxins that bring on diseases has spurred efforts, naturally enough, to develop those proteins synthetically. This new class of biotherapeutic protein drugs, or biologics, tends to be more effective at combating pathological conditions with less side effects, since they mimic endogenously produced proteins, which target highly specific parts of the invader (antigens). Unfortunately, the production of biologics is easier said than done; it typically requires hundreds of process steps to assemble one of these complex biotherapeutic proteins. Therefore, it should come as no surprise that the PreEMT™ platform recently acquired by Pressure BioSciences Inc. (OTCQB: PBIO) is a welcome addition to biologic development.

The company recently announced the signing of an agreement with an international biopharmaceutical company to assess the potential of the PreEMT™ technology as the basis for a unique manufacturing process and as an enhancement to the quality of a key protein-based drug currently under development (http://nnw.fm/Yr5lG).

Many currently available drugs are synthesized chemically, with molecular structures that are “well defined and relatively simple” (http://nnw.fm/abUv6). Their simplicity makes them easy to produce and easy for the human body to assimilate. A good example is acetylsalicylic acid (ASA), the active ingredient in aspirin, which has a molecular weight of about 180 grams per mole. Generally, such drugs are swallowed in pill or liquid form before entering the gastrointestinal system and blood stream by diffusion through the intestinal wall. Once in the blood, they have access to the entire body, their tiny size allowing them to penetrate cell membranes easily.

Biologics, by contrast, are much larger compounds that mimic the complex endogenous proteins produced by the immune system. They are generally composed of hundreds of amino acids and may carry a weight as high as 150,000 grams per mole. Biologics will bind to the specific cell receptors associated with a particular disease. For example, monoclonal antibodies are adept at recognizing very specific structures on the surface of cells. This specificity means that healthy cells are not adversely affected, resulting in less side effects. This is one reason that treatment by biologics can be superior to regimens developed with traditional combinatorial chemistries.

Because of their complexity, the manufacture of biotherapeutic proteins is prone to errors, very often falling prey to aggregation and misfolding. Misfolding occurs when the normal, three-dimensional structure of a protein becomes distorted, which may lead the protein to aggregate, a result that is quite the opposite of the benign outcomes intended in the manufacture of biologics. Many pathological conditions occur naturally by misfolded proteins. The list includes Alzheimer’s disease, which affects about 10 percent of the adult population over 65 years old in North America, as well as Parkinson’s disease and Huntington’s disease. However, PBIO’s PreEMT patented technology could reduce the incidence of misfolding in manufacture.

“PreEMT results in the dissolution of protein aggregates, which may have a significant impact on the quality of protein drugs by improving protein activity, homogeneity, and stability, as well as by reducing undesirable immunogenic properties”, Dr. Alexander Lazarev, PBIO’s vice president of R&D, stated in a news release.

Richard T. Schumacher, president and CEO of PBIO, added “Importantly, should the PreEMT technology result in more efficient production of high quality protein-based therapeutics for any biopharmaceutical company developing new protein-based therapeutics, manufacturing-scale licenses have the potential to generate millions of dollars in annual royalty revenue for PBIO.”

The technology is likely to find application across a wide range of proteins in reducing aggregation levels in bulk or final formulations, thereby improving product safety. PreEMT is scalable, and it is expected to significantly reduce manufacturing costs.

The acquisition of the PreEMT technology gives PBIO a footprint in the very large and growing biologics contract research services sector. The company is also busily developing its recently patented Ultra Shear Technology (UST) platform. The scalable, pressure-based UST technology creates stable nanoemulsions of otherwise immiscible fluids. It can be used to extend the shelf life of homogenized dairy products without refrigeration, for example. All the while, PBIO continues its focus on its core product line that generated $2.2 million in 2017 revenue: the development of pressure cycling technology (PCT)-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, soil and plant biology, forensics and counter-bioterror applications.

For more information, visit the company’s website at www.PressureBioSciences.com

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