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News Article | May 23, 2017
Site: www.prnewswire.com

"We are excited to welcome Henry to the Aldevron team," said Michael Chambers, the company's CEO. "His commitment to biomanufacturing excellence is unsurpassed." Chambers added that Aldevron will soon reach 200 employees to meet the requirements of the rapidly expanding antibody, cell and gene therapy industries. "I am honored to be joining Aldevron at a pivotal point in the company's evolution," said Hebel. "Aldevron has an excellent reputation in the industry and has been serving a global client base for the past two decades." Hebel has more than 20 years of biopharmaceutical manufacturing experience. Most recently, he served as vice-president of operations for Aeglea Biotherapeutics of Austin, Texas, where he was responsible for strategic and operational planning. Previously he served as vice-president of drug development for Terapio, also in Austin, where he successfully developed a radiation countermeasure product allowing entry into government countermeasure development programs. Additionally, Hebel was chief operating officer of VGXI (previously known as ADViSYS), of Houston, Texas, where he led cGMP plasmid DNA production in support of FDA and USDA clinical submissions. VGXI successfully obtained regulatory approval for the world's first commercial plasmid-based gene therapy. Prior to his work at VGXI, Hebel served as key account manager at Qiagen, in a strategic joint venture known as the "pAlliance," which was focused on contract plasmid DNA production. His early career included work as senior manager of bioprocessing for GeneMedicine, and he has experience in antibody product development and manufacturing at Tanox Biosystems. Hebel holds a Bachelor of Science in Zoology and an MBA from Texas A&M University in College Station, Texas. He has been awarded multiple patents and dozens of his writings have been published in industry journals. Hebel succeeds Ron Robson, who recently retired as Aldevron's COO after 18 years with the company. Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmid DNA, RNA and gene editing enzymes for research, clinical, and commercial applications. Aldevron's clients are developing revolutionary treatments in many fields including oncology, neuroscience, infectious disease and rare diseases. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-SourceTM quality system. Company headquarters are in Fargo, N.D., with additional facilities in Madison, Wisc., and Freiburg, Germany. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/aldevron-names-biomanufacturing-veteran-henry-hebel-as-new-chief-operating-officer-300462473.html


-- Henry Hebel has been named Chief Operating Officer of Aldevron , a leading global provider of contract plasmid DNA manufacturing, protein production and antibody discovery services Hebel will guide strategy and global planning, customer service, procurement, sourcing, supply chain and global operations of the company's facilities in Fargo, N.D., Madison, Wisc., and Freiberg, Germany. He will be heavily involved in the construction, startup, and certification of the company's new 70,000 square foot GMP (Good Manufacturing Practices) biologics manufacturing facility in Fargo, part of Aldevron's new seven-acre corporate campus."We are excited to welcome Henry to the Aldevron team," said Michael Chambers, the company's CEO. "His commitment to biomanufacturing excellence is unsurpassed."Chambers added that Aldevron will soon reach 200 employees to meet the requirements of the rapidly expanding antibody, cell and gene therapy industries."I am honored to be joining Aldevron at a pivotal point in the company's evolution," said Hebel. "Aldevron has an excellent reputation in the industry and has been serving a global client base for the past two decades."Hebel has more than 20 years of biopharmaceutical manufacturing experience. Most recently, he served as vice-president of operations for Aeglea Biotherapeutics of Austin, Texas, where he was responsible for strategic and operational planning.Previously he served as vice-president of drug development for Terapio, also in Austin, where he successfully developed a radiation countermeasure product allowing entry into government countermeasure development programs.Additionally, Hebel was chief operating officer of VGXI (previously known as ADViSYS), of Houston, Texas, where he led cGMP plasmid DNA production in support of FDA and USDA clinical submissions. VGXI successfully obtained regulatory approval for the world's first commercial plasmid-based gene therapy.Prior to his work at VGXI, Hebel served as key account manager at Qiagen, in a strategic joint venture known as the "pAlliance,"which was focused on contract plasmid DNA production. His early career included work as senior manager of bioprocessing for GeneMedicine, and he has experience in antibody product development and manufacturing at Tanox Biosystems.Hebel holds a Bachelor of Science in Zoology and an MBA from Texas A&M University in College Station, Texas. He has been awarded multiple patents and dozens of his writings have been published in industry journals.Hebel succeeds Ron Robson, who recently retired as Aldevron's COO after 18 years with the company.Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmid DNA, RNA and gene editing enzymes for research, clinical, and commercial applications. Aldevron's clients are developing revolutionary treatments in many fields including oncology, neuroscience, infectious disease and rare diseases. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-SourceTM quality system. Company headquarters are in Fargo, N.D., with additional facilities in Madison, Wisc., and Freiburg, Germany.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.4.2-2 | Award Amount: 3.93M | Year: 2011

EpoCan aims to develop and implement a comprehensive interdisciplinary strategy to assess the long-term risks of erythropoietin (EPO) and its derivatives (epoetins) on tumour growth progression and thromboembolic events in cancer patients, cardiovascular events, and the development of cancer in chronic kidney disease. Approximately 400,000 patients across Europe receive epoetins treatment each year. Recent meta-analysis data have raised concerns over increased mortality in some patient groups. Hence the urgent need to evaluate the risk-benefit ratio of epoetin treatment and its potential long-term effects. EpoCan brings together a multidisciplinary consortium of 12 world leading academic, industrial and medical partners, with long-standing, complementary expertise in haemostasis, oncology and EPO biology. EpoCan aims to (1) Identify, detect and measure possible long-term hazards of epoetin treatment; (2) Develop novel prognostic tools and new complementary therapeutic reagents: (3) Evaluate the risk-benefit ratio to pave the way for new safety and efficacy criteria. EpoCan will: (a) Utilize a wide array of cellular models to thoroughly analyze EPO/EPO receptor(EPO-R)interaction and signalling, to define the relationship between EPO-R expression in tumour samples and the clinical outcome in cancer patients; (b) Establish and test new, personalized, predictive tools (EPO-R peptide antagonists, novel specific anti-EPO-R monoclonal antibodies, thromboembolic tests); (c) Create new murine models as hosts for tumour implantation subjected to EPO and derivatives established above; (d) Screen and analyze clinical databases; (e) Define models to predict hazardous versus safe/beneficial roles of epoetins in the treatment of cancer and kidney failure associated anaemia. Data obtained will be integrated into coherent models using novel computational algorithms developed for EpoCan. Results are expected to have broad ramifications, with special relevance for clinical oncology.


Kwilas S.,U.S. Army | Kishimori J.M.,U.S. Army | Josleyn M.,U.S. Army | Jerke K.,U.S. Army | And 3 more authors.
Current Gene Therapy | Year: 2014

Sin Nombre virus (SNV) and Andes virus (ANDV) cause most of the hantavirus pulmonary syndrome (HPS) cases in North and South America, respectively. The chances of a patient surviving HPS are only two in three. Previously, we demonstrated that SNV and ANDV DNA vaccines encoding the virus envelope glycoproteins elicit high-titer neutralizing antibodies in laboratory animals, and (for ANDV) in nonhuman primates (NHPs). In those studies, the vaccines were delivered by gene gun or muscle electroporation. Here, we tested whether a combined SNV/ANDV DNA vaccine (HPS DNA vaccine) could be delivered effectively using a disposable syringe jet injection (DSJI) system (PharmaJet, Inc). PharmaJet intramuscular (IM) and intradermal (ID) needle-free devices are FDA 510(k)-cleared, simple to use, and do not require electricity or pressurized gas. First, we tested the SNV DNA vaccine delivered by PharmaJet IM or ID devices in rabbits and NHPs. Both IM and ID devices produced high-titer anti-SNV neutralizing antibody responses in rabbits and NHPs. However, the ID device required at least two vaccinations in NHP to detect neutralizing antibodies in most animals, whereas all animals vaccinated once with the IM device seroconverted. Because the IM device was more effective in NHP, the Stratis® (PharmaJet IM device) was selected for follow-up studies. We evaluated the HPS DNA vaccine delivered using Stratis® and found that it produced high-titer anti-SNV and anti-ANDV neutralizing antibodies in rabbits (n=8/group) as measured by a classic plaque reduction neutralization test and a new pseudovirion neutralization assay. We were interested in determining if the differences between DSJI delivery (e.g., high-velocity liquid penetration through tissue) and other methods of vaccine injection, such as needle/syringe, might result in a more immunogenic DNA vaccine. To accomplish this, we compared the HPS DNA vaccine delivered by DSJI versus needle/syringe in NHPs (n=8/group). We found that both the anti-SNV and anti-ANDV neutralizing antibody titers were significantly higher (p-value 0.0115) in the DSJI-vaccinated groups than the needle/syringe group. For example, the anti-SNV and anti-ANDV PRNT50 geometric mean titers (GMTs) were 1,974 and 349 in the DSJI-vaccinated group versus 87 and 42 in the needle/syringe group. These data demonstrate, for the first time, that a spring-powered DSJI device is capable of effectively delivering a DNA vaccine to NHPs. Whether this HPS DNA vaccine, or any DNA vaccine, delivered by spring-powered DSJI will elicit a strong immune response in humans, requires clinical trials. © 2014 Bentham Science Publishers.


Hooper J.W.,U.S. Army | Brocato R.L.,U.S. Army | Kwilas S.A.,U.S. Army | Hammerbeck C.D.,U.S. Army | And 7 more authors.
Science Translational Medicine | Year: 2014

Polyclonal immunoglobulin-based medical products have been used successfully to treat diseases caused by viruses for more than a century. We demonstrate the use of DNA vaccine technology and transchromosomal bovines (TcBs) to produce fully human polyclonal immunoglobulins (IgG) with potent antiviral neutralizing activity. Specifically, two hantavirus DNA vaccines [Andes virus (ANDV) DNA vaccine and Sin Nombre virus (SNV) DNA vaccine] were used to produce a candidate immunoglobulin product for the prevention and treatment of hantavirus pulmonary syndrome (HPS). A needle-free jet injection device was used to vaccinate TcB, and hightiter neutralizing antibodies (titers >1000) against both viruses were produced within 1 month. Plasma collected at day 10 after the fourth vaccination was used to produce purified a α-HPS TcB human IgG. Treatment with 20,000 neutralizing antibody units (NAU)/kg starting 5 days after challenge with ANDV protected seven of eight animals, whereas zero of eight animals treated with the same dose of normal TcB human IgG survived. Likewise, treatment with 20,000 NAU/kg starting 5 days after challenge with SNV protected immunocompromised hamsters from lethal HPS, protecting five of eight animals. Our findings that the a-HPS TcB human IgG is capable of protecting in animal models of lethal HPS when administered after exposure provides proof of concept that this approach can be used to develop candidate next-generation polyclonal immunoglobulinbased medical products without the need for human donors, despeciation protocols, or inactivated/attenuated vaccine antigen. Copyright 2014 by the American Association for the Advancement of Science.


Sin Nombre virus (SNV; family Bunyaviridae, genus Hantavirus) causes a hemorrhagic fever known as hantavirus pulmonary syndrome (HPS) in North America. There have been approximately 200 fatal cases of HPS in the United States since 1993, predominantly in healthy working-age males (case fatality rate 35%). There are no FDA-approved vaccines or drugs to prevent or treat HPS. Previously, we reported that hantavirus vaccines based on the full-length M gene segment of Andes virus (ANDV) for HPS in South America, and Hantaan virus (HTNV) and Puumala virus (PUUV) for hemorrhagic fever with renal syndrome (HFRS) in Eurasia, all elicited high-titer neutralizing antibodies in animal models. HFRS is more prevalent than HPS (>20,000 cases per year) but less pathogenic (case fatality rate 1-15%). Here, we report the construction and testing of a SNV full-length M gene-based DNA vaccine to prevent HPS. Rabbits vaccinated with the SNV DNA vaccine by muscle electroporation (mEP) developed high titers of neutralizing antibodies. Furthermore, hamsters vaccinated three times with the SNV DNA vaccine using a gene gun were completely protected against SNV infection. This is the first vaccine of any kind that specifically elicits high-titer neutralizing antibodies against SNV. To test the possibility of producing a pan-hantavirus vaccine, rabbits were vaccinated by mEP with an HPS mix (ANDV and SNV plasmids), or HFRS mix (HTNV and PUUV plasmids), or HPS/HFRS mix (all four plasmids). The HPS mix and HFRS mix elicited neutralizing antibodies predominantly against ANDV/SNV and HTNV/PUUV, respectively. Furthermore, the HPS/HFRS mix elicited neutralizing antibodies against all four viruses. These findings demonstrate a pan-hantavirus vaccine using a mixed-plasmid DNA vaccine approach is feasible and warrants further development. © 2013 The Authors.


Brocato R.,U.S. Army | Josleyn M.,U.S. Army | Ballantyne J.,Aldevron | Vial P.,University for Development | Hooper J.W.,U.S. Army
PLoS ONE | Year: 2012

Andes virus (ANDV) is the predominant cause of hantavirus pulmonary syndrome (HPS) in South America and the only hantavirus known to be transmitted person-to-person. There are no vaccines, prophylactics, or therapeutics to prevent or treat this highly pathogenic disease (case-fatality 35-40%). Infection of Syrian hamsters with ANDV results in a disease that closely mimics human HPS in incubation time, symptoms of respiratory distress, and disease pathology. Here, we evaluated the feasibility of two postexposure prophylaxis strategies in the ANDV/hamster lethal disease model. First, we evaluated a natural product, human polyclonal antibody, obtained as fresh frozen plasma (FFP) from a HPS survivor. Second, we used DNA vaccine technology to manufacture a polyclonal immunoglobulin-based product that could be purified from the eggs of vaccinated ducks (Anas platyrhynchos). The natural "despeciation" of the duck IgY (i.e., Fc removed) results in an immunoglobulin predicted to be minimally reactogenic in humans. Administration of ≥5,000 neutralizing antibody units (NAU)/kg of FFP-protected hamsters from lethal disease when given up to 8 days after intranasal ANDV challenge. IgY/IgYΔFc antibodies purified from the eggs of DNA-vaccinated ducks effectively neutralized ANDV in vitro as measured by plaque reduction neutralization tests (PRNT). Administration of 12,000 NAU/kg of duck egg-derived IgY/IgYΔFc protected hamsters when administered up to 8 days after intranasal challenge and 5 days after intramuscular challenge. These experiments demonstrate that convalescent FFP shows promise as a postexposure HPS prophylactic. Moreover, these data demonstrate the feasibility of using DNA vaccine technology coupled with the duck/egg system to manufacture a product that could supplement or replace FFP. The DNA vaccine-duck/egg system can be scaled as needed and obviates the necessity of using limited blood products obtained from a small number of HPS survivors. This is the first report demonstrating the in vivo efficacy of any antiviral product produced using DNA vaccine-duck/egg system.


Grant
Agency: Department of Defense | Branch: Army | Program: STTR | Phase: Phase I | Award Amount: 100.00K | Year: 2013

In this Phase I STTR proposal we will determine the ruggedness of the genetic immunization technique in the production of duck egg derived immunoglobulin; specifically the natural F(ab")2 analog, IgY^Fc. We have already demonstrated that potently neutralizing duck egg antibodies generated with an early candidate Andes virus DNA vaccine, delivered via intramuscular electroporation, can protect after lethal challenge. We now seek to optimize the elements necessary to deploy a commercially viable platform system for the rapid production of passive immunity products as countermeasures to emerging viral threats. Mammalian or avian (Mallard duck) codon optimized Andes virus DNA vaccine variants of the original will be administered to ducks utilizing electroporation or a needle-free device. An increased potency and/or response frequency along with a decreased response time would represent a significant and enabling progression in the field. The work will be coupled with a small parallel study in sheep with Andes and Junin virus DNA vaccine candidates. Endpoints as measures of success will be determined by known correlates of protection using plaque reduction neutralizing tests and pseudoviral assays. Simple reactogenicity studies will also be performed with all full-length and despeciated immunoglobulin"s and the results compared to licensed polyclonal and monoclonal products.


Grant
Agency: Department of Defense | Branch: Army | Program: STTR | Phase: Phase II | Award Amount: 725.55K | Year: 2013

In this Phase II STTR proposal we will demonstrate the scalability and ruggedness of the production system necessary for the commercialization of the goose egg-derived immunoglobulin product that is a countermeasure to the lethal (40 %) Hantavirus Pulmonary Syndrome caused by Andes Virus (ANDV). A major objective will be creating a Quality System (QS) around the global process that aligns it with standards commensurate with FDA guidance. Related objectives will be the development of critical assays and the harmonization of the related Standard Operating Procedures into the QS. Pharmacokinetic and repeat dose studies will be performed that will allow us to better evaluate the quantities to be used and routes of delivery for the anti-ANDV product in the challenge study. Endpoints as measures of success would be the reproducible production of 5 g lots of low impurity anti-ANDV and the use of such lots affording clinically significant protection up to five days after challenge. These results would indicate the commercial viability of a platform that is based on the use of genetic immunization in geese as a means of creating therapies for Category-A pathogens for which no countermeasures or vaccines exist.


Trademark
Aldevron | Date: 2011-04-19

Assays and reagents for use in genetic research; Reagents for scientific or medical research use.

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