DelSite files US drug application for nasal powder H5N1 influenza vaccine

Published: 21-Aug-2008
Regulatory

DelSite Biotechnologies has filed an Investigational New Drug (IND) application with the FDA for its lead product candidate GelVac nasal powder H5N1 influenza vaccine


DelSite Biotechnologies has filed an Investigational New Drug (IND) application with the FDA for its lead product candidate GelVac nasal powder H5N1 influenza vaccine

The IND application is for a Phase I safety and immunogenicity study of this influenza vaccine in healthy volunteers.

The GelVac nasal powder platform combines the advantages of nasal immunisation and powder formulation and offers benefitssuch as room temperature stability, cold chain-free distribution and needle-free administration, making this vaccine particularly suited to treating influenza pandemics.

Dr Carlton Turner, ceo of DelSite, said: "I believe the vaccine industry is undergoing a transition to a safer, more user friendly delivery platform. The needle platform system, which has served mankind well and saved many lives, has also created controversy over the perceived or real effects caused by heavy metal preservatives and adjuvants. Additionally, the requirements for shipping vaccines cold or frozen, as well as maintaining those conditions until administering, have added expense and limited distribution, particularly to those most needy in the developing areas of the world."

The nasal powder formulation needs no preservatives, no adjuvants, no needles and cold storage is not required. Since one kilogram of the GelSite polymer in the GelVac formula can make more than 8 million doses, the cost per vaccine dose can be significantly reduced.

See more

You may also like

Manufacturing

Signal Group launches MCERTS approved VOC emissions monitor

Read more
New SOLAR CEMNEX analyser offers advanced compliance and connectivity features

Trending Articles

  1. Douglas Pharmaceuticals sets new benchmark for capsule quality with CI Precision Partnership delivers compliance confidence, efficiency gains and reduced waste
  2. Balancing innovation and accessibility in amino acid testing Butterworth Laboratories expands analytical capabilities to support compliance with Ph. Eur. standards
  3. You need to be a subscriber to read this article.
    Click here to find out more.
    Quality management during manufacturing changes: part I Change is a universal constant and continues to accelerate in the realms of pharmaceutical, medical device and in-vitro diagnostic manufacturers who face ever-increasing pressure to optimise costs while maintaining high product quality and patient safety standards
  4. NICE recommends enfortumab vedotin with KEYTRUDA for adults in England/Wales with untreated metastatic urothelial cancer The results from the Phase III study EV-302/KN-A39 showed nearly a doubling of survival rates in patients compared with those who received platinum-based chemotherapy, which is the current standard of care in the UK
  5. FDA makes groundbreaking decision to waive clinical efficiency studies for monoclonal antibody biosimilars The University of Illinois secured the first-ever FDA acceptance to waive clinical efficiency studies (CESs) for the biological drugs

Upcoming event

Enhancing probiotic stability through smarter formulation and packaging strategies

18 September 2025 | Virtual See all

You may also like

Manufacturing

Signal Group launches MCERTS approved VOC emissions monitor

New SOLAR CEMNEX analyser offers advanced compliance and connectivity features
You need to be a subscriber to read this article.
Click here to find out more.
Packaging

Cloud labelling and serialisation: the new frontline of traceability in drug delivery

As drug delivery evolves to accommodate a new wave of data-driven innovation, the need for traceability and compliance throughout the supply chain is paramount. Innovative cloud-based solutions enable pharmaceutical companies to navigate these demands with confidence
Regulatory

Novo Nordisk’s oral semaglutide scores EU approval for cardiovascular benefits

Rybelsus is now the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke
Manufacturing

Douglas Pharmaceuticals sets new benchmark for capsule quality with CI Precision

Partnership delivers compliance confidence, efficiency gains and reduced waste
Regulatory

New NICE thresholds: good news for rare disease drugs but process remains complex

Recent changes introduced by NICE will ultimately see more ultra-rare disease drugs get to market, but Dan Williams, CEO at SynaptixBio, says the process remains challenging
Manufacturing

Balancing innovation and accessibility in amino acid testing

Butterworth Laboratories expands analytical capabilities to support compliance with Ph. Eur. standards
You need to be a subscriber to read this article.
Click here to find out more.
Manufacturing

Quality management during manufacturing changes: part I

Change is a universal constant and continues to accelerate in the realms of pharmaceutical, medical device and in-vitro diagnostic manufacturers who face ever-increasing pressure to optimise costs while maintaining high product quality and patient safety standards
Subscribe now