Biopharmaceutical Uniform Crystallization Test Bed

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 50nbsp; 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.nbsp; 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.