Navigation Links
DelSite Working Toward Solving Delivery of Influenza Vaccine in Pandemic Situations

IRVING, Texas, Officials of DelSite Biotechnologies, Inc., a wholly-owned subsidiary of Carrington Laboratories, Inc. said the company's novel powder-based vaccine delivery technology may solve most of the key obstacles that delay influenza pandemic preparedness which were discussed by experts at the worldwide "Options for the Control of Influenza VI Conference" held in Toronto, Canada last week.

Long-standing problems associated with the production, storage and distribution of vaccines to meet the challenges posed by a pandemic outbreak of an influenza virus, such as the bird flu (H5N1), were highlighted in a series of presentations at the conference. The Conference was supported by the U.S. Center for Disease Control (CDC) and the International Society for Influenza and other Respiratory Virus Diseases (ISIRV).

More than 1,500 influenza experts from around the world attended the conference, including government policy makers, pharmaceutical executives, researchers, physicians, epidemiologists and other professionals focused on the control of influenza.

The following key needs were cited:

1. The ability to have an adequate stockpile of vaccines. Current vaccines must be refrigerated during storage and distribution. Despite its cost and inconvenience, cold storage does not significantly extend the short shelf life of influenza antigens and vaccines. DelSite's GelVac(TM) powder vaccine system has been shown to stabilize and preserve an influenza antigen at room temperature for more than two (2) years without loss of potency.

2. The capability to implement rapid distribution in the event of a full pandemic. According to one flu expert, if the next influenza pandemic is equivalent to the flu pandemic that occurred in 1957 (H2N2 virus), timing of actions by the U.S. government would be critical. In 1957, under transportation systems available at the time, it took only six months for the virus to trav el from China to the U.S. With today's faster transportation systems allowing 1.2 million people to enter the U.S. each day, it is anticipated the virus would spread much faster. For containment of disease, a massive and expeditious vaccination program, along with other measures, would have to be initiated as quickly as possible.

According to the same expert, about 10 million doses per week for 25 weeks would have to be delivered in order to protect the U.S. population during a full pandemic. Current cold chain distribution systems may not be able to respond, but a nasal powder vaccine that can be shipped at room temperature and be self-administered may be a solution. DelSite's nasal powder technology meets these criteria and could add additional value by providing immunological protection to recipients at the site where viruses normally enter the body: the respiratory tract.

3. An effective adjuvant to make the vaccine more powerful. One proposed approach was to have the vaccine in one vial and the adjuvant in another vial, and then combine the vaccine with the adjuvant at the site of vaccination. It was suggested that this approach would allow or better stockpiling of the adjuvant, which would have a longer shelf life than the vaccine antigen. However, this system may double distribution logistics and therefore may be less feasible. DelSite has data indicating that the GelVac(TM) powder formulation could be shipped as a powder and reconstituted with sterile water just prior to injection. GelVac(TM) powder formulation also has a strong immuno-enhancing or adjuvant-like effect when it is injected after reconstitution through sustained release of the injected antigen. This effect could provide protection for more people at lower doses without the need for a separate adjuvant.

4. A way to reduce the number of months required to produce necessary antigen, if different from stockpile. Currently, chicken eggs are used in th e U.S. for production of vaccine antigens. This egg-based manufacturing process requires a minimum of six months. The newest technology available uses a mammalian cell line to produce antigens. This cell-based technology is more efficient, faster, and eliminates allergic problems caused by egg proteins.

DelSite's GelVac(TM) powder vaccine technology works with egg- or cell-based antigen. In addition, the use of a whole virus (whole virion) provides more potent vaccines than vaccines produced using split or partial parts of the virus; the GelVac(TM) technology may be used to deliver vaccines made from any of these methods.

DelSite's GelVac(TM) platform is based on the GelSite(R) polymer, a negatively-charged linear polymer with a molecular weight greater than 450,000 which is derived from a natural source and is classified as a GRAS (generally regarded as safe) by the FDA.

GelSite(R) is produced in kilogram quantities under FDA good manufacturing practices for human drugs (cGMP) in an ISO-certified facility. Each kilogram of the GelSite(R) polymer can be used to manufacture approximately 5 to 8 million vaccine doses. Plant material used in the production of GelSite(R) polymer is recognized as certified organic by the U.S. Department of Agriculture, European Union and government of Costa Rica.

After the Influenza Conference concluded, Dr. Yawei Ni, chief scientific officer of DelSite, stated, "Our GelVac(TM) powder vaccine delivery platform was the only powder system at the conference, and I believe it can be used to solve or alleviate basic technology problems that would be created by a worldwide pandemic. We have completed the Phase I safety study for the powder system and will file an IND with the FDA for a Phase I clinical study using a H5N1 antigen later this year."


Related medicine news :

1. Working in shifts may cause damage to your health
2. Junior Doctors Working Long Hours May Perform Poorly
3. New UK Policy Threatens The Flexible Working Scheme
4. Medicare Drug Plan Is Not Working in The US
5. Warning! Working For Long Hours On Your Computer Can Be Lethal
6. Stressed Pregnant Working Mothers Put Their Unborn Child’s Life in Dange
7. Working of Drug Department on Hold Without Drug Analyst
8. Doctor Faces Disbarment For Working In Multiple Hospitals
9. Computational Model Reveals Working of AZT in Body
10. Scientists Working On Drug Trial Guidelines
11. Scientists Uncover Complex Workings of Sperm
Post Your Comments:

(Date:11/30/2015)... ... 2015 , ... Live Very Well is excited to announce ... . The multi-carrier insurance exchange platform offers individual vision and dental ... compare, quote and match plans to meet their needs. , Beginning December ...
(Date:11/30/2015)... ... November 30, 2015 , ... Until now, the St. ... in the MOMS (Management of Myelomeningocele Study) trial. One of these exclusion criteria was ... a BMI of 18.5 to 24.9 is considered normal, 25 - 29.9 is overweight ...
(Date:11/30/2015)... ... 30, 2015 , ... Stress, anxiety, illness, infection or even a need for ... , Heather Spader, MD, a new pediatric neurosurgeon at Joe DiMaggio Children’s Hospital in ... to tumors. , “Bad headaches that don’t go away, that don’t have ...
(Date:11/30/2015)... ... November 30, 2015 , ... Thermi™, a ... to announce that its ThermiRFR temperature controlled radiofrequency platform has received CE marking ... radiofrequency platform which uses temperature as a clinical endpoint. The technology has ...
(Date:11/30/2015)... ... 30, 2015 , ... MOSI recently added two state-of-the-art augmented reality (AR) experiences ... Jurassic to their collection of interactive exhibits within the Kids In Charge! building. In ... guests to get closer than ever to a range of animals as they drink, ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... 30, 2015   Royal Philips (NYSE: ... industry,s first MRI guided user interface and automatic scan ... with MR Conditional implants, such as knee and hip ... Radiological Society of North America Annual Meeting (RSNA) . ... diagnostic confidence of this growing patient population. ScanWise Implant ...
(Date:11/30/2015)... India , November 30, 2015 ... 2014, and is expected to grow at a CAGR of 7.6% ... was valued at USD 135.6 million in 2014, and is ... 2020. --> According to the new Market Research Report ... invasive, non-invasive), By End User (Hospitals, ambulatory care, others) - Analysis ...
(Date:11/30/2015)... 2015 2014RestatedChange%Turnover 545,575 , 518,852 , 5.2 Cord Blood ... , 9.8 Hospital Management Service Income , ... Medical Insurance Administration Service Income , 2,780 , ... , 89,645 , 94,580 , ... 2,917 , (3.3) Gross Profit 395,857 , ...
Breaking Medicine Technology: