SBIR-STTR Award

Pharmaceuticals in general, and biopharmaceuticals specifically, are often best formulated as microscopic crystals. The crystalline state is most stable, allows a high-concentration, low-viscosity parenteral formulation, and facilitates alternate routes of administration. There is a requirement that the crystals be small, a few micrometers or less, and uniform, the same size within a few per cent. The problem: most recombinant protein biopharmaceuticals do not crystallize uniformly. A solution to this problem has been discovered in on-orbit crystallization experiments, which produced very uniform sized crystals. Manufacturers are creating demand for on-orbit testing of uniform crystallization protocols, but suitable hardware and ISS research opportunities are inadequate. Techshot proposes a business plan in which cost and time saving versatile flight hardware and flexible flight opportunities are made openly available to corporate and institutional users seeking improvements or refinements in product purification, formulation and/or delivery. Hardware and flight plans on ISS will be offered in which factorial and/or real-time photography experiments can be performed on the basis of Techshot’s regular ISS access and versatile hardware fleet. In Phase I research Techshot will (1) adapt up to four different existing hardware modules for this specific application, (2) test these modules in model protein crystallization experiments in the laboratory, and (3) perform mathematical modeling for a ground-based crystallization reactor with adjustable parameters for approximating the relevant low-gravity physics. In Phase II research Techshot will prepare the hardware modules for flight readiness, prepare an aggressive ISS use plan, and construct and operate an optimizable ground-based reactor. The intended outcome is a business paradigm for hastening the availability of stable biopharmaceuticals with favorable options for delivery. Potential NASA Applications (Limit 1500 characters, approximately 150 words) NASA has solicited research topics in this area of pharmaceutical production on spacecraft making deep space voyages to solve problems of availability and stowage. Such projects include short-cut production of biopharmaceuticals by stored microbial cells but also need to include short-cut purification schemes. A crystallization plan, Techshot’s proposed innovation, could eliminate several (chromatography, extraction, etc.) downstream steps toward such on-orbit formulation, although non-NASA commercialization is the project’s primary goal. Potential Non-NASA Applications (Limit 1500 characters, approximately 150 words) Success in producing a crystalline product will save big due to longer ambient stability, lower delivery volume and novel routes of administration of their product, whether it is an approved pharmaceutical or an emerging therapeutic. Techshot intends to offer crystallization research capabilities on the ISS and in labs to companies seeking opportunities in the crystalline biopharmaceutical field.

Pharmaceuticals in general, and biopharmaceuticals specifically, often are best formulated as crystals. The crystalline state is the most stable of matter, allows a high-concentration, low-viscosity parenteral formulation, and facilitates alternate routes of administration. There is a requirement that the crystals be small, below 100 or 50 micrometers, and uniform (the same size within a few percent). The problem: most recombinant protein biopharmaceuticals do not crystallize uniformly. A solution to this problem has been discovered in on-orbit experiments, which produced size coefficients of variation below ~8%. Manufacturers are creating demand for on-orbit testing of uniform crystallization protocols, but suitable hardware and ISS research opportunities are inadequate. Techshot proposes a business plan utilizing its versatile fleet of flight hardware, and flexible flight opportunities. These will be made available to industrial and institutional customers seeking improvements/refinements in product purification, formulation and/or delivery. Hardware and flight plans will be offered in which factorial and/or real-time photography experiments can be performed. In the Phase I Techshot (1) adapted four different existing hardware modules for this application, (2) tested them in model protein crystallization experiments in the lab, and (3) performed mathematical modeling for a ground-based crystallization reactor with adjustable parameters for approximating the relevant low-gravity physics. In Phase II, Techshot will (a) define and document an experiment design for a flight demonstration, (b) design and integrate hardware for flight readiness, (c) prepare and execute an ISS use plan, (d) and design and construct a flight-like EDU for an innovative dynamic microscope cassette. The intended outcome is a business paradigm for hastening the availability of stable biopharmaceuticals with favorable options for delivery. Potential NASA Applications (Limit 1500 characters, approximately 150 words): NASA has solicited research topics in the area of pharmaceutical production on spacecraft making deep space voyages to solve problems of availability and stowage. Such projects include short-cut production of biopharmaceuticals by stored microbial cells but also need to include short-cut purification schemes. A clever crystallization plan, Techshot’s proposed innovation, could eliminate several traditional (chromatography, extraction, etc.) downstream steps toward such on-orbit formulation. Potential Non-NASA Applications (Limit 1500 characters, approximately 150 words): Companies that succeed in producing a crystalline product will save enormously due to longer ambient stability, lower delivery volume and novel routes of administration, whether it is an approved pharmaceutical or an emerging therapeutic. Patients and insurers likewise benefit. Therefore, Techshot intends to offer for hire a variety of crystallization capabilities in Earth and space-based labs. Duration: 24