Manufacturing problems hindering production of MedImmune's
intranasal flu vaccine FluMist have finally been resolved at the
company's Liverpool, UK facility, with doses on track to be
available for this year's flu season.
Novartis last week began construction of a major new flu vaccine
manufacturing facility in North Carolina, the very first cell
culture-derived flu vaccine plant in the United States.
Several major manufacturers have pledged millions of doses of H5N1
vaccine to go towards a global stockpiling scheme initiated by the
World Health Organization to protect against the threat of an avian
flu pandemic.
Biopharma firm Vivalis has announced several licence agreements for
its proprietary cell line technology, adding to the list of
companies applying the technology to develop and commercialise new
human influenza vaccines.
Thailand is the first recipient of six major grants the World
Health Organization (WHO) is distributing to developing countries
to establish in-country manufacturing capacity for influenza
vaccine.
Russian researchers have developed an intranasal influenza vaccine
using a novel adjuvant technology, with plans to develop what could
become the first tablet flu vaccine formulation.
Drug giants Novartis and GlaxoSmithKline (GSK) have been awarded
contracts with the US government to develop adjuvant technology for
pandemic influenza, to potentially increase the number of doses to
be distributed among US citizens.
MedImmune's latest version of their inhalable flu vaccine, FluMist,
has been approved by the US Food and Drug Administration (FDA). The
new formulation can now be stored in a refrigerator rather than
frozen, which proved a major...
Drug giant GlaxoSmithKline (GSK) has been awarded a contract with
the US government to supply 800,000 doses of flu vaccine to the US,
where a bird flu pandemic still remains a threat.
California's Health and Human Services (HHS) has decided to
temporarily suspend a ban on mercury-based flu vaccines given to
children under three, citing a vaccine shortage caused by
production delays.
With the first clinical trial of its cell culture-based seasonal
influenza vaccine commencing in the US, Sanofi Pasteur has
demonstrated the production scale potential of a cell line in a
successful bioreactor run of 20,000L.
For the first time Merck has opened the doors of its
under-construction manufacturing plant in North Carolina to public
officials, boasting it will eventually contribute about two-thirds
of its annual live-virus vaccine production.
Agricultural firm Embrex has installed its in ovo delivery
system and egg remover at the production facility of Shenzhen
Neptunus Interlong, believed to be the largest and most advanced
human influenza vaccine manufacturing plant...
In a landmark decision that will speed up the manufacturing of
influenza vaccines, the US Food and Drug Administration (FDA) has
approved the use of reverse genetics technology in the production
of MedImmune's seasonal intranasal...
Maryland is no longer in the running for a $500m (€392m) vaccine
manufacturing plant Novartis is seeking to build in the US, as
speculation about which state will host America's first cell
culture-derived influenza vaccine plant...
As America desperately waited for its influenza vaccines, Chiron
had to deal with major quality control issues between July and
October 2005 at its troubled vaccine manufacturing plant in
Liverpool according to a US Food and Drug...
Frost & Sullivan has awarded biopharmaceutical firm Cytogenix
with its 2006 award for innovation in biotechnology processing for
its cell-free manufacturing method that enables generation of large
quantities of high-purity DNA...
Sanofi pasteur's vaccine manufacturing plant in Pennsylvania, where
half of America's influenza vaccines are made, has been served with
a warning letter by the US Food and Drug Administration (FDA),
asking for measures to...
FFF Enterprises has just been awarded a new contract to distribute
GlaxoSmithKline's (GSK's) flu vaccine in the US, making it the
largest flu vaccine distributor for the second year running.
Tests have begun on a new bird flu vaccine that its US developer
MedImmune hopes will prove more effective and provide several
advantages over current injectable flu vaccines in the event of a
bird flu pandemic.
In the company's largest investment of its kind in Asia,
GlaxoSmithKline (GSK) has decided to build a new vaccine
manufacturing plant in Singapore, as several products in its
pipeline approach commercialisation.
The US government has awarded five-year contracts totaling $1bn
(€780m) to five drug companies to develop and produce cell-based
vaccines to fight influenza, in preparation for a possible bird flu
pandemic.
A large-scale process, which focuses on highly purified and high
viral titer vectors, may facilitate the fast track development of
Adenovirus and AAV-based recombinant DNA vaccines for diseases such
as the Avian Flu.
MedImmune will soon ramp up production of its intranasal flu
vaccine after the US Food and Drug Administration (FDA) approved
its new and larger flu vaccine manufacturing facility in Speke,
England.
GlaxoSmithKline (GSK) has positioned itself to dominate the US flu
vaccine market after it completed the acquisition of Canadian
vaccine company ID Biomedical for $1.7 billion (€1.15 billion) last
week.
Pall Corporation has revealed a unique approach for speeding
vaccine production, which could provide a solution to the
potentially huge demand for vaccines by governments and
pharmaceutical manufacturers in response to the avian flu...
After positive trial results in Europe, Chiron has initiated a US
Phase I/II study of a new flu vaccine offering faster production in
the event of an vaccine supply shortfall or an avian flu pandemic.
Chiron has warned it will yet again fall short of targets for its
US flu vaccine deliveries this year due to continuing production
problems with its British manufacturing plant.
Pharmaceutical manufacturers, Wyeth, are to phase out manufacturing
at its US facility as part of its consolidation plans, which will
see the gradual phasing out of all operations at the New York
facility by late 2008.
US generics company Andrx, currently in the throes of an
investigation into its manufacturing procedures by the Food and
Drug Administration, announced the resignation of chief financial
officer John Hanson.
DelSite Biotechnologies has filed a Drug Master File (DMF) with the
US Food and Drug Administration for an excipient used for drug
delivery - called GelSite - used to formulate vaccines, proteins
and peptide drugs that are delivered...
If there was any doubt that GlaxoSmithKline aims to become the
premier world supplier of influenza vaccine, it should be laid to
rest by yesterday's news that the number two drugmaker is buying
Canadian company ID Biomedical.
US biotechnology company Chiron has rejected a takeover offer from
Swiss drugmaker Novartis, saying the latter's $40 a share offer
does not pass muster.
Novartis has offered to buy the remaining shares it does not
already own in US headquartered Chiron for $4.5 billion, laying to
rest speculation in the marketplace that it had been eyeing up
Germany's Schering AG.
The world's second largest pharmaceutical company, GlaxoSmithKline,
is investing close to €100 million in a new manufacturing facility
in Dresden, Germany, for flu vaccines.
Chiron says it will be unable to supply any Begrivac influenza
vaccine to markets outside the US during the 2005/6 flu season,
just days after admitting it has sterility problems at a
manufacturing plant.
US drugmaker Chiron is facing a significant shortfall in the volume
of influenza vaccine it will be able to ship to markets outside the
US as a result of sterility problems uncovered at another of its
manufacturing plants, reports...
Chiron has said it will be unable to meet its projections for flu
vaccine production this year, because it has been unable to get
production back up to speed at its manufacturing facility in
Liverpool, UK, as quickly as hoped. The...
US generic company Able Laboratories ceased all its manufacturing
and recalled products yesterday after major problems emerged with
its quality control procedures, reports Phil Taylor.
Sanofi-Aventis subsidiary Sanofi Pasteur, has been awarded a $97m
(€75m) contract to accelerate the production process for new cell
culture influenza vaccines in the US and the design of a US-based
cell-culture vaccine manufacturing...
Although US biotechnology company, Chiron, fully intends to be able
to provide its Fluvirin flu vaccine for the 2005/6 flu season, it
says it is difficult to predict the number of doses it will be able
to produce.
The UK regulatory authorities have cleared Chiron to resume
production of its influenza vaccine Fluvirin at its facility in
Liverpool, lifting a ban imposed in October because of
contamination problems at the plant.
Chiron said yesterday that the UK and US regulatory authorities are
expected to conduct a series of inspections of its manufacturing
facility in Liverpool, which was forced to cease production of
influenza vaccines last year, leading...
In-Pharmatechnologist.com's periodic round-up of manufacturing
developments from around the world sees Fujisawa expanding in
Ireland, Solvay partnering in Russia, Vietnam's machinery firms
undercutting competitors and...
Belgium-based GlaxoSmithKline Biologicals has licensed a new
production technology for its vaccines business that should do away
with the need to use preservatives in the manufacturing process.
Chiron has had to cease production at a UK plant making influenza
vaccines, exacerbating an existing shortage of the jab ahead of
this year's flu season.
The number of shots delivered in national influenza immunisation
programmes could be increased - without making any additional
vaccine - by simply using a syringe developed by Becton Dickinson.
Chiron's has completed its acquisition of UK vaccine and drug
delivery specialist PowderJect, making it the second-largest
manufacturer of flu vaccines worldwide.
