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Vaccine Technology - Articles and news items
Industry news / 28 October 2015 / Kate Douetil
GSK’s candidate shingles vaccine is a non-live vaccine and combines gE, a protein found on the virus that causes shingles with an adjuvant system, AS01B, which enhances the immunological response to gE…
Calixar and VirPath develop an innovative manufacturing process for high performance influenza vaccines
Industry news / 23 September 2014 / Andrew Lloyd & Associates
A new antigens formulation against pandemic flu (A H1N1 virus) proved six times more effective than other vaccines…
Influenza viruses are members of the Orthomyxoviridae family and are a major cause of respiratory tract disease in humans and many animal species. There are three influenza virus types that cause human disease: A, B and C. Type A are further subtyped based on the antigenicity of the hemagglutinin (HA) and neuraminidase (NA) surface proteins and have been associated with serious epidemics and pandemics. Sixteen HA and nine NA subtypes have been identified in birds (one of the natural hosts) and several subtypes have been transmitted to humans. The influenza virus genome is comprised of eight segments of negative-strand RNA that encode for 11 proteins. The genome is under continuous evolution due to random errors in viral replication that allow the virus to evade the host immune system through the genetic processes of antigenic drift and shift. Antigenic drift is the gradual evolution of viral strains due to frequent point mutations within the dominant antibody-binding sites in the HA and NA proteins, which potentially occurs every time the virus replicates. This process drives the need for continuous surveillance of the circulating seasonal influenza strains and their inclusion in the annual vaccination campaign. In contrast, antigenic shift is only seen in influenza A viruses and occurs by re-assortment (i.e., packaging of genes from two or more different viruses). This leads to a new virus subtype, which can result in a pandemic strain if the virus is pathogenic, can spread from human to human and a substantial portion of the population has no preexisting immunity. During the past 100 years, there have been four pandemics (see Table 1 on page 22), three of which have been associated with substantial disease burden and mortality…
Ingredients, Issue 1 2014 / 19 February 2014 / M. Babu Medi and Ramesh Chintala, Vaccine Drug Product Development, Merck & Co, Inc and Akhilesh Bhambhani, Novel Adjuvants, Formulation and Delivery Technologies, Merck & Co, Inc.
Excipients are an integral part of pharmaceutical products and play an important role in the formulation development of both small and large molecule pharmaceuticals. The type and extent of excipient use depends on several factors, including the type of active ingredient, route of administration, dosage form, target population and indication and so forth. With a growing number of protein therapeutics and vaccines in development, stabilisation during processing and storage presents a major challenge for the pharmaceutical industry. Biologics and vaccines are inherently unstable and prone to degradation by several physical and chemical degradation mechanisms. Therefore, a variety of excipients are required to stabilise biologics and vaccines during processing and storage. Selection and use of the appropriate excipients enable development of novel therapies and robust pharmaceutical products. The purpose of this article is to present an overview of the challenges associated with biologic and vaccine formulation development as well as different types of excipients used to stabilise these products.
European Commission approves nasal spray vaccine FLUENZ for the prevention of seasonal influenza in children
The European Commission has granted marketing authorisation to FLUENZ Influenza Vaccine…
The FDA approval of Menveo for use in children 2 to 10 years of age is based on Phase III trial data involving 5,297 participants in that age group…
Issue 6 2010, Vaccine Development / 16 December 2010 / Abina M. Crean & Anne C. Moore, School of Pharmacy, University College Cork and Conor O’Mahony, Tyndall National Institute, University College Cork
Vaccination represents the primary public health measure to combat infectious diseases. However, limitations of cold-chain storage, vaccine wastage, hazardous sharps-waste and the requirements for trained personnel add significant and unsustainable financial and logistic costs to immunisation programmes. Developments of needle-free methods should aim to overcome these logistics issues from the very start of the vaccine production process. Dermal vaccine administration using microneedle-based devices promises to be one such needle-free method that addresses all of these issues. Methods of stabilisation of vaccines onto or incorporated into microneedles should be developed to permit seamless transition and cost-effectiveness from vaccine bulk-up to final product. This review examines recent developments in microneedle technology and highlights the current challenges to translate this technology into practice.
Ninety per cent of the world’s medical research funding is being spent on just ten per cent of the world’s health problems, mostly those afflicting the residents of wealthy countries.
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