SBIR-STTR Award

TopoGEN, in a strategic partnership with Nanoly Bioscience, proposes to develop ambient condition stable Research Use Only (RUO) products (e.g., enzymes, antibodies, and Kits) through the use of a synthetic, safe, and biocompatible polymer encapsulation technology (NanoShield). NanoShield uses a patent protected photodegradable poly-(ethylene glycol) (PEG) hydrogel network to encapsulate and shield sensitive bio- molecules from thermal stress encountered during storage and transit. The enzymes highlighted in this proposal are important anti-cancer and antibiotic targets in modern drug development. These enzymes, like RUO products from many other companies, which are used in basic and translational research, are highly labile and require costly dry ice packaging for both domestic and international distribution. Dry ice packaging, though commonly used, presents major problems including high cost and hazardous material classification, with the additional risk of total product loss upon shipping delay. The US is currently a global leader in the RUO marketplace, which is expected to grow to nearly US $13B by 2021, and if the US is to maintain its position in this market, these issues must be addressed. The technology developed herein will eliminate the requirement for expensive cold chain services for RUO product distribution and storage. NanoShield’s capability to eliminate the need for cold chain storage and distribution will lead to significant reductions in logistics costs, and will provide a considerable market advantage to US companies that adopt the technology. Nanoly will develop effective formulations for a number of TopoGEN’s RUO products, focusing on enzymes (e.g., Top1, Top2? and ?, and bacterial gyrases). NanoShield’s unique chemistry allows for the rational tuning of the polymer network to achieve maximal payload stability. We will test at least 24 NanoShield formulations to maintain protein function and stability, as measured by assays developed by TopoGEN, following stress at a number of temperatures (i.e., ambient, 40?C, 50?C). These assessments will be carried out for short (several days) or long (many months) term storage. TopoGEN will then conduct a limited field ‘beta’ test using the fully formulated enzyme (Top1). As one of TopoGEN’s best selling products, Human Top1 will allow for sufficient prototype testing events to achieve sufficient statistical rigor, and will test NanoShield’s compatibility with other products. Additionally, Top1 will be shipped to a large global network of Company Distributors to field test the ability of NanoShield to maintain product stability over a wide range of storage conditions in real-world situations. We will rely heavily on e-commerce and web portal-based feedback to gauge product stability and robustness in the hands of end-users. We will leverage the findings from this proposal to develop a full line of NanoShield stabilized TopoGEN RUO products. TopoGEN and Nanoly, together, will pursue SBIR Phase II funding for expanding field tests and full development of a line of NanoShield stabilized products in the RUO product industry. Phase II will also examine translational functionality of NanoShield. The potential for NanoShield in stabilizing labile bio-products extends into a wide array of applications, from vaccines in undeveloped countries to providing ambient stable yet critical medical supplies for our military in battle or other health care workers in harm’s way.

Public Health Relevance Statement:
Narrative

Public Health Relevance:
we are developing Nanotech-based materials (NanoShield) that will reduce cost and improve access to important biomolecules used as therapeutics and research reagents. NanoShield will inhibit aggregation of biomolecules, preventing loss of potency and avoiding severe side effects. The potential is far-reaching. In addition to public health benefits (including stabilizing vaccines for use in third world economies, providing battlefield medical supplies for our troops and others in harm's way) this work has immediate and significant potential to enhance the economic health of US Biotechnology companies who must ship labile products abroad on dry ice (considered a dangerous goods shipment). By eliminating dry ice shipping, American made biotechnology products will be far more competitively priced in global markets, thereby increasing US export activity into emerging markets (such as Asia). !

Project Terms:
Address; Adopted; Adverse effects; American; Antibiotic Therapy; Antibodies; Antineoplastic Agents; antineoplastic antibiotics; Area; Asia; base; Basic Science; biocompatible polymer; Biological Assay; Biological Response Modifier Therapy; Biological Sciences; biomaterial compatibility; Biotechnology; Chemistry; Chronic Disease; Classification; Cold Chains; combat; Complex; cost; Country; Dangerousness; Data; design; Development; DNA; drug development; Drug Industry; Drug Screening; Dry Ice; e-commerce; Encapsulated; Enzymes; ethylene glycol; Event; Exposure to; Failure; Feedback; field study; Formulation; Foundations; Freezing; Funding; Future; Goals; Growth; Hazardous Substances; Health Benefit; health economics; Health Personnel; Health Services Research; Human; Hydrogels; Ice; Improve Access; improved; Individual; Industry; innovation; International; Legal patent; Life; Light; Logistics; Maintenance; Manufacturer Name; Measures; medical supply; Methods; Military Personnel; Modeling; Modernization; Monitor; nano; Nanotechnology; new technology; Outcomes Research; Peer Review; Penetration; Pharmacologic Substance; Phase; Play; Polymers; portability; Positioning Attribute; Posture; prevent; Price; Production; protein function; Proteins; prototype; Public Health; public health relevance; Publishing; Reagent; Refrigeration; Reporter; Research; research and development; Risk; Role; Sales; Shipping; Ships; Small Business Innovation Research Grant; Stress; Sum; System; Technology; Temperature; Testing; therapeutic enzyme; Therapeutic Human Experimentation; thermal stress; Translating; Translational Research; Trauma; user-friendly; Vaccines; Validation; web portal; Work

TopoGEN, in a strategic partnership with Nanoly Bioscience, proposes to develop ambient condition stable Research Use Only (RUO) products (e.g., enzymes, antibodies, and Kits) through the use of a synthetic, safe, and biocompatible polymer encapsulation technology (NanoShield). NanoShield uses a patent protected photodegradable poly-(ethylene glycol) (PEG) hydrogel network to encapsulate and shield sensitive bio- molecules from thermal stress encountered during storage and transit. The enzymes highlighted in this proposal are important anti-cancer and antibiotic targets in modern drug development. These enzymes, like RUO products from many other companies, which are used in basic and translational research, are highly labile and require costly dry ice packaging for both domestic and international distribution. Dry ice packaging, though commonly used, presents major problems including high cost and hazardous material classification, with the additional risk of total product loss upon shipping delay. The US is currently a global leader in the RUO marketplace, which is expected to grow to nearly US $13B by 2021, and if the US is to maintain its position in this market, these issues must be addressed. The technology developed herein will eliminate the requirement for expensive cold chain services for RUO product distribution and storage. NanoShield’s capability to eliminate the need for cold chain storage and distribution will lead to significant reductions in logistics costs, and will provide a considerable market advantage to US companies that adopt the technology. Nanoly will develop effective formulations for a number of TopoGEN’s RUO products, focusing on enzymes (e.g., Top1, Top2? and ?, and bacterial gyrases). NanoShield’s unique chemistry allows for the rational tuning of the polymer network to achieve maximal payload stability. We will test at least 24 NanoShield formulations to maintain protein function and stability, as measured by assays developed by TopoGEN, following stress at a number of temperatures (i.e., ambient, 40?C, 50?C). These assessments will be carried out for short (several days) or long (many months) term storage. TopoGEN will then conduct a limited field ‘beta’ test using the fully formulated enzyme (Top1). As one of TopoGEN’s best selling products, Human Top1 will allow for sufficient prototype testing events to achieve sufficient statistical rigor, and will test NanoShield’s compatibility with other products. Additionally, Top1 will be shipped to a large global network of Company Distributors to field test the ability of NanoShield to maintain product stability over a wide range of storage conditions in real-world situations. We will rely heavily on e-commerce and web portal-based feedback to gauge product stability and robustness in the hands of end-users. We will leverage the findings from this proposal to develop a full line of NanoShield stabilized TopoGEN RUO products. TopoGEN and Nanoly, together, will pursue SBIR Phase II funding for expanding field tests and full development of a line of NanoShield stabilized products in the RUO product industry. Phase II will also examine translational functionality of NanoShield. The potential for NanoShield in stabilizing labile bio-products extends into a wide array of applications, from vaccines in undeveloped countries to providing ambient stable yet critical medical supplies for our military in battle or other health care workers in harm’s way.

Public Health Relevance Statement:
Narrative

Public Health Relevance:
we are developing Nanotech-based materials (NanoShield) that will reduce cost and improve access to important biomolecules used as therapeutics and research reagents. NanoShield will inhibit aggregation of biomolecules, preventing loss of potency and avoiding severe side effects. The potential is far-reaching. In addition to public health benefits (including stabilizing vaccines for use in third world economies, providing battlefield medical supplies for our troops and others in harm's way) this work has immediate and significant potential to enhance the economic health of US Biotechnology companies who must ship labile products abroad on dry ice (considered a dangerous goods shipment). By eliminating dry ice shipping, American made biotechnology products will be far more competitively priced in global markets, thereby increasing US export activity into emerging markets (such as Asia). !

NIH Spending Category:
Bioengineering; Biotechnology; Nanotechnology

Project Terms:
Address; Adopted; American; Antibiotic Therapy; Antibodies; Antineoplastic Agents; antineoplastic antibiotics; Area; Asia; base; Basic Science; biocompatible polymer; Biological Assay; Biological Response Modifier Therapy; Biological Sciences; biomaterial compatibility; Biotechnology; Chemistry; Chronic Disease; Classification; Cold Chains; combat; Complex; cost; Country; Dangerousness; Data; design; Development; DNA; drug development; Drug Industry; Drug Screening; Dry Ice; e-commerce; Encapsulated; Enzymes; ethylene glycol; Event; Exposure to; Failure; Feedback; field study; Formulation; Foundations; Freezing; Funding; Future; Goals; Growth; Hazardous Substances; Health Benefit; health economics; Health Personnel; Health Services Research; Human; Hydrogels; Ice; Improve Access; improved; Individual; Industry; innovation; International; Legal patent; Life; Light; Logistics; Maintenance; Manufacturer Name; Measures; medical supply; Methods; Military Personnel; Modeling; Modernization; Monitor; nano; Nanotechnology; new technology; off-patent; Outcomes Research; Peer Review; Penetration; Pharmacologic Substance; Phase; Play; Polymers; portability; Positioning Attribute; Posture; prevent; Price; Production; protein function; Proteins; prototype; Public Health; public health relevance; Publishing; Reagent; Refrigeration; Reporter; Research; research and development; Risk; Role; Sales; Shipping; Ships; side effect; Small Business Innovation Research Grant; Stress; Sum; System; Technology; Temperature; Testing; therapeutic enzyme; Therapeutic Human Experimentation; thermal stress; Translating; Translational Research; Trauma; user-friendly; Vaccines; Validation; web portal; Work