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...
Discovery Laboratories is claiming progress in its struggle to
correct manufacturing problems related to Surfaxin, its
experimental respiratory treatment for infants, yet the goal of
overcoming the process validation issues that prevent...
Cardinal Health is the latest firm to benefit from Roche's global
recruitment drive for manufacturers to help boost its supplies of
the bird flu drug coveted by governments across the world -
Tamiflu.
A recent paper has emerged, which details results of a clinical
laboratory test and its ability to accurately predict drug response
in lung cancer. The test gives way to the possibility of less
invasive testing.
UK firm PowderMed has contracted US firm Althea Technologies to
manufacture clinical supplies of its flu vaccine that can
significantly speed up production.
An enzyme-based process operated by Lonza for the production of the
major chiral building block for Pfizer's Lipitor, the world's best
selling drug, has won its designer Codexis a top green chemistry
award for its high yield,...
SR Pharma has recruited Genzyme, BioSpring and OctoPlus to
formulate and manufacture its lead RNAi therapeutic product Atu027
to good manufacturing practice (GMP) standards, as its liposomal
drug delivry system moves forward.
Technology firm Symyx has acquired Autodose, a maker of precision
powder-dispensing equipment, as it seeks to develop the next
generation of high-throughput benchtop automation systems.
Inspection and certification group SGS has officially launched a
laboratory in Shanghai dedicated to quality control testing of
pharmaceuticals, biopharmaceuticals and medical devices, as China's
appetite for contract analytical...
Genevac have developed a Fast Lyophilisation Process that aims to
provide the ultimate solution to the problems encountered by lab
technicians when handling HPLC solvents.
In an incident that state and federal environmental regulators are
treating as "serious," Merck released 25 gallons of a
cyanide-containing chemical from its West Point facility in
Pennsylvania to the sewer, killing hundreds...
Cambrex Bio Science has successfully completed its first monoclonal
antibody project in the company's new cell culture bioreactor, as
well as its first small-large molecule conjugation project.
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...
New Brunswick Scientific (NBS) has introduced two new benchtop
incubator shakers, the first in a range of eight new models
replacing the original C-Line. The shakers have been designed to
allow reproducible results all the way down...
A new generation of drugs that target specific areas of the body
has created new challenges for dissolution testing, as many recent
active pharmaceutical ingredients (APIs) are poorly soluble in
traditional media and need novel testing...
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...
New guidelines for the import and manufacture of medical devices in
India have now come into effect, aimed at increasing world
confidence in medical devices made in the region.
BioPartners has failed to bring its second biosimilar product into
Europe after the European Agency for the Evaluation of Medicinal
Products (EMEA) issued a negative opinion on its hepatitis C drug,
citing characterisation, manufacturing...
Activotec makes available an entry-level Supercritical Fluid
Extractor (SFE) to suit routine analytical work in smaller
laboratories that might require many features typically found in
more costly SFE equipment.
French purification specialist Novasep has unveiled a new series of
preparative high-performance liquid chromatography (HPLC) columns
that are ideally suited for the purification of any amount of
product.
After launching its flagship oral insulin spray in Ecuador last
December, Generex is finally gearing up to take on big pharma in
the global non-injectable insulin arena and has picked Cardinal
Health to help meet manufacturing demands.
Hyclone has unveiled a new single-use bioreactor at the BioLOGIC
exhibition in Amsterdam which promises the same performance with
traditional stainless steel bioreactors but with the benefits of
single use in which all the contact...
Microsoft has awarded Pfizer with its Pharmaceutical and Life
Sciences Innovation Award for its manufacturing management system
which revolutionalises the scaling up and monitoring of active
pharmaceutical ingredient (API) production,...
Innovata is moving forward with its dry powder pulmonary insulin
inhaler, which it claims has a formulation superior to Exubera,
gearing up for Phase II clinical trials and anticipating a new
partnership deal by the end of the year.
As the shortage of cartridges of its injectable diabetes drug
Byetta reaches critical levels, Amylin Pharmaceuticals is seeking
to expand manufacturing capacity and is exploring a nasal spray
formulation of the medicine with drug...
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.
Alpharma has asked one of the largest manufacturers of bulk active
pharmaceutical ingredients (APIs) in China, Zhejiang Hisun
Pharmaceutical, to help it double its capacity of making
vancomycin.
Analytik Jena has started production of its first analytical
apparatus to be made entirely in China representing a new venture
for the company as it aims to advance into a market that has
experienced unprecedented growth in the analytical...
UK-based Malvern Instruments has revealed that its next-generation
particle size analysis system is being used by French contract
manufacturer Valois in the validation of its unique nasal spray
device.
A toxic group of plant extracts has been found to protect animal
tissue against the lack of blood that occurs in stroke giving rise
to a new direction in the development of stroke treatment.
Millipore has unveiled new disposable Tangential Flow Filtration
(TFF) assemblies that reduce validation efforts, increase process
speed and mitigate risks.
Laboratory service provider, LabConnect has announced its
intentions to expand into Central and Eastern Europe by adding
Synevo Medicover Laboratory Services to its LabConnect network,
becoming the first US-based central laboratory...
The world's first drug made from a genetically engineered goat has
been given the thumbs up in Europe after being initially rejected
in February. The decision has reopened the door for "pharming,"
where transgenic animals...
The US Food and Drug Administration (FDA) has urged the pharma
industry to develop preservative-free nasal sprays, however, there
is currently a vacuum of manufacturers that can fulfil such a
requirement.
Testing services and contract manufacturing firm Microtest has
announced it will invest $7.5m (€6m) in new facilities to expand
its offering of pharmaceutical and virology testing services and
fill/finish production capacity.
PerkinElmer has announced the acquisition of C&A Service
Solutions that will strengthen its OneSource laboratory service by
channelling its range of services into a single outlet.
Laureate Pharma is planning to invest up to $9m (€7.1m) to expand
its biopharmaceutical manufacturing facility in New Jersey with a
new pilot production plant, as it seeks more capacity to cope with
increased demand from clients for...
Continuing its aggressive entry into Europe's custom manufacturing
arena, Nicholas Piramal (NPIL) has today acquired Pfizer's
manufacturing facility in Northumberland, in a deal that could earn
it more than $350m (€280m)...
The first ever monoclonal antibody obtained starting from
transgenic plants with the purpose of purifying a human vaccine has
been registered with Cuban authorities, meaning cigars may not be
the only application the country's...
A new laboratory test that identifies patients who benefit most
from targeted cancer drugs was the talk of the annual meeting of
the American Society of Clinical Oncology (ASCO) as the test's
accuracy is sure to save hundreds...
BioMedica Diagnostic is to open a manufacturing facility in Ghana
that will produce affordable laboratory equipment whilst meeting
the need for a home grown African diagnostic solution for the
Continent's medical problems.
Pall is organising a free chromatography seminar in Paris this week
presented by leading chromatographers from the pharmaceutical,
biotechnology and biologicals industries.
Drug delivery firm Egalet has asked SP Medical, a manufacturer of
moulded plastics and coatings, to make sufficient clinical grade
quantities of its therapeutics using injection moulding, which
allows for greater uniformity and reproducibility...
Nastech has secured a contract with Procter & Gamble (P&G)
to ramp up manufacturing capacity for a new needle-free drug to
beat osteoporosis, in anticipation of meeting expected global
demand once the product is approved.
A new one-step test that is designed to distinguish
heterophile-positive, infectious mononucleosis (IM) from other
common symptomatic infections, claims to deliver a 99 per cent
sensitivity score, significantly improving on current...
After recently opening up shop in nearby Singapore, SGS has now
brought its contract testing services to neighbouring China to
continue to cash in on the demand for such services in the
Asia-Pacific region.