A Retrospective Introduction
Ology Bioservices is a trusted biopharmaceutical partner, providing high quality products and services for over 15 years, on-time and on-budget. Ology Bioservices, Inc. (Ology Bio) is a privately owned, US-based, mid-sized, Commercial Development and Manufacturing Organization (CDMO) providing services from sequence to Phase II, to both government and commercial clients. Ology Bio is headquartered in Alachua, FL at its best-in-class biopharmaceutical manufacturing facility, with additional sites in Berkeley, CA and Frederick, MD. Ology Bio is approved to produce drug substance to US, WHO and EU companies.
Ology Bio started out as a small biotech company called Nanocoat Technologies (2000),a product of the Sid Martin Biotechnology Incubatorof Alachua, Florida, with expertise in nanometer-scale particle technologydesigned for use in the development of new drugs and medical devices (i.e. NanoGent,NanoDTPA™, NanoDOX®,NanoDRY®, and NanoFUSE®DBM) and for increasing the efficacy of existing oral, parenteral and topical drugs. In2002, Nanocoat Technologies rebranded to Nanotherapeutics, Inc.and continued developing business through corporate alliances and government contracts. In 2013, Nanotherapeutics was awarded a DoD-funded defense contract to build an Advanced Development and Manufacturing (ADM) facility, which will ensure capacity in the event of a bioterrorism or radiological biothreat in the US. During construction of the 183,000 square foot, BSL-3 ready facility in Alachua, FL, Nanotherapeutics negotiated novation of XOMA Corporation’s biodefense program including on-going programs, associated materials and drug substance productions. In 2016, Nanotherapeutics rebranded to Ology Bioservices, Inc.(Ology Bio) when the corporate business plan changed to include commercial services in conjunction with government contracts funneled through the ADM facility.
Bioterrorism, Outbreaks and Plague
Ology Bio has a history as a “disruptor” in the medical countermeasure efforts by the US Government, as it has consistently moved government-funded programs forward at faster than expected rates with a series of significant successes. These events began with the 2005 US government program called ‘Project Bioshield‘(passed into law on July 21, 2004) funded to support the development of biotechnical and biopharmaceutical products and medical devices for use as medical countermeasure(s) (MCM) against “category A” agents capable of weaponization in acts of bioterrorism against the US. Ology Bio was 1 of 10 recipients of the program grants with specific focus on development of a delivery system for treatment against Pneumonic plague and tularemia.
Category A agentsare those biothreats posing the highest risk to public health and national security. These agents when properly delivered can be transmitted readily through a population resulting in high death counts and public panic. These agents are therefore the highest priority biothreats capable of causing great damage and include:
- Anthrax (Bacillus anthracis) – 2001 “Amerithrax” attack against US government
- Botulism (Clostridium botulinum toxin) – 1990’s attack of US military installations in Japan
- Plague (Yersinia pestis) – 1945 Japanese ‘Operation Cherry Blossom at Night’
- Smallpox (variola major) – 1970-80’s Soviet stockpile
- Tularemia (Francisella tularensis)
- Viral hemorrhagic fevers with two sub-categories:
- Filoviruses (Ebola, Marburg)
- Arenaviruses (Lassa, Machupo)
Ology Bioservices has partnered with several government departments and agencies to develop MCMs for biological agents released as biothreats or naturally-occurring. These partnerships have targeted tularemia, radiation poisoning, Human Immunodeficiency Virus, small pox, H5N1 influenza, Ebola virus, Ross River virus, Chikungunya disease, West Nile virus, botulinum neurotoxin, malaria and plague.
Below is an abbreviated timeline of Ology Bio’s government-funded awards, proprietary products and strategic alliances.
2005a–DoD contract for NanoGent delivering prophylaxis and treatment against pneumonic plague and tularemia.
2005b– NIAID award to XOMA for mAb-based DP against BoNT/A, acquired by Ology Bio in 2016.
2005c– NIAID award for NanoDTPA™ capsule to remove radioactive compounds from patients.
- IND filed in 2010.
- 2011, FDAdeclared NanoDTPA™ capsule an orphan drug product.
- 2011 BARDA awarded fundingfor further development of DTPA for americium, curium, or plutonium exposures.
2006– SBIR with RF Monolithics Inc. for a patented detection method to find improvised explosive devices (IEDs).
2007a– CRADA with National Cancer Institute (Vaccines) for proprietary nanoparticle delivery system of an HIV-peptide vaccine.
2007b– BARDA/NIAID (Pandemic and All Hazards Preparedness Act) award for antibiotics against pneumonic plague and tularemia.
2008– IND submission for NanoDOX® Hydrogel, a proprietary doxycycline product for the topical treatment of chronic wounds.
- 2010 DoD(2009 – Accelerating Treatment for Trauma Wounds) contract for NanoDOX® Hydrogel use in a clinical trial.
2009a–IND submission for NanoBUPTM, an opiate addiction treatment using the proprietary NanoDRY® particle delivery system.
2009b– NIAID/NIH award development of an aerosolized antiviral treatment for smallpox (Variola major) using cidofovir.
2009c– Acquired GelSite® biopolymer and GelVacTMnasal powder platform technology from DelSite (Carrington Laboratories, Inc.).
- 2010-2011 Successful Phase 1 clinical trial for GelVac H5N1 Flu vaccine.
2009d–NIAID (Soligenix, Inc.) consortium for platform production of thermally stable vaccines to counter high-priority biothreats.
2013– DoD contract for an Advanced Development and Manufacturing (ADM) facility.
Note: designed to produce medical countermeasures against chemical, biological, radiological, and nuclear attacks and outbreaks of naturally occurring emerging and genetically engineered infectious diseases.
2013b– BARDA award for influenza vaccine under Fill-Finish Manufacturing Network (FFMN) Pilot Production.
2014a–Strategic alliance with PharmAthene to advance development of specific MCMs for the U.S. biodefense market.
2014b– BARDA award for fill/finish of Zmapp, an antibody-based treatment of Ebola by Mapp Pharmaceuticals.
2015a– BARDA/HHS two awards under FFMN for manufacture, process validation and FDA filing of select MCMs.
2015b– Baxter divested Vero Cell vaccines platform and associated assets including:
- H5N1, H1N1, seasonal influenza vaccines
- Ross River virus, Chikungunya disease and West Nile virus vaccine programs.
- Partnered with Takeda to expand Vero Cell technology produced influenza vaccine availability to Japanese markets.
2015c–Novated XOMA Corporation’s Biodefense program for anti-BoNT A, B, C/D and E drug products.
2016-Licensed NanoFUSE®DBM (demineralized bone matrix-bone void filler) to Amend Surgical, Inc.
2017a–Licensed Triapine® (3-AP) a ribonucleotide reductase (RNR) inhibitor in nucleotide biosynthesis to Trethera Corporation.
2017b–Alliance with Battelle to facilitate expedited research and development of MCMs for deployed military forces.
2017c– Rebranded Nanotherapeutics to Ology Bioservices, Inc.
2018a–Global Health Initiative Fund award to develop a vaccine candidate for treatment of Malaria.
2018b– DoD/Defense Advanced Research Projects Agency (DARPA), for manufacture of the mAb114 antibody against Ebola.
2019a– DoD award for development of a platform technology using monoclonal antibodies as MCMs against biothreats
2019b– DoD award for platform use to develop a prophylactic drug product against the Plague bacterium, Yersinia pestis.
Continuity and Commercial expansion
The ADM facility is owned by Ology Bioservices and operates under government-oversight to ensure continuity of all government issued task orders and contracts for MCM development now and in the future. Extensive capacity was built into the ADM facility, which is available for use in Commercial business. The ADM facility is ISO 9001 and 13485 certified, for GMP manufacture. Ology Bio has continually expanded its capabilities in keeping with the needs of government and commercial clients, offering an equally expanding list of commercial services. Ology Bio’s Commercial Services (in alphabetical order) include:
- Bioanalytical development and testing
- Cell banking
- Drug substance production (GMP to 2000L)
- Molecular/vector development
- Plasmid production
- Process development and scale up (Non-GMP to 200L)
- Project management
- Regulatory support
- Small batch fill/finish
- Vaccine production
- Viral banking
Ology Bio is expanding its capacity to provide services in support of Gene and Cell Therapy therapeutic development. Ology Bio will soon be opening a small batch manufacturing facility, with 2 upstream manufacturing suites, in Alameda, CA.