The contract manufacturing sector lagged behind the rest of the
outsourcing industry serving the pharmaceutical sector in 2004, but
there are encouraging signs for the future, reports Phil
Taylor.
Researchers in the US have found that blocking the COX-1, not COX-2
enzyme, might lead the way to prevent and treat the most common and
fatal form of ovarian cancer.
Millipore has introduced a single-use prefilter for clarification
steps in mammalian cell synthesis that continues the trend towards
increasing use of disposable technologies in the bioprocessing
environment, reports Phil Taylor.
Boehringer Ingelheim and Slovenian company BIA Separations have
collaborated on a new separation and purification system that
should improve the production of plasmid DNA.
A study suggesting combination therapy could stop the spread and
halt the growth of skin melanomas could pave the way for a better
understanding of the disease, and thus, the development of more
effective long-term treatment options...
As the US Food and Drug Administration continues its deliberations
on generic biopharmaceuticals, the industry body representing
generic drug manufacturers has said that the time has now come for
the agency to make some hard decisions,...
A second market research report has found evidence that production
capacity in the market for contract manufacturing of
biopharmaceuticals is now in excess, in contrast to the hitherto
prevailing wisdom that the sector has been suffering...
Hamilton Life Science Robotics has taken Invitrogen's Gateway
Technology one step further by creating an automated cloning system
that monitors and tracks each plate undergoing various processes.
The system aims to further refine...
The pharmaceutical and biotechnology industries in the 'new' EU
countries are rapidly expanding, presenting considerable potential,
although parallel imports remain a challenge.
Integra Biosciences has launched the CELLine disposable flask,
which harnesses membrane technology that is suitable for
recombinant protein expression and high yield monoclonal antibody
production.
Boehringer Ingelheim Austria has been selected to win a Technology
Leadership award by Frost & Sullivan for its activities in the
contract manufacture of biotherapeutic proteins, and particularly
plasmid DNA.
Genetix Limited has launched the ClonePixFL, a mammalian cell
imaging and picking instrument that builds upon the success of the
ClonePix adding fluorescent capabilities to its clone picking
abilities.
GE Healthcare has launched the first in a new family of
chromatography media designed specifically to handle the high
volumes used in the bioprocessing sector.
Construction of the UK National Biomanufacturing Centre, an
ambitious project aimed at helping biotechnology start-ups get
their product ideas into clinical trials, is progressing on
schedule and should be ready to start production...
UK packaging equipment supplier Isopak has introduced an all-in-one
system designed to eliminate the difficulties of handling and
packing pharmaceuticals, foods and cosmetics in sachets.
Despite burgeoning demand for biopharmaceutical drugs, little
progress is being made toward the improving efficiency and reducing
costs in conventional biomanufacturing processes using microbial or
mammalian fermentation systems.
US chemicals company Aceto has broken cover and is now racing to
develop a leading player in the market for generic versions of
biologic drugs, even though the regulatory route to approval of
these products is far from established.
Qiagen has announced a new product line for the separation,
purification and handling of nucleic acids, an essential process in
drug discovery, which aims to improve over current applied methods,
which suffer from decreased sensitivity...
The predicted deficit in manufacturing capacity for biologic drugs
that has been tipped to impede the development of the market has
not materialised, with capacity exceeding demand, according to new
market research.
Switzerland-based BioPartners has submitted a second Marketing
Authorisation Application in Europe for a generic copy of a
biologic drug under the recently agreed European Union framework
for so-called 'biosimilar' drugs.
Germany's Christ Water Technology has developed a ready-to-connect
water filtration plant that is specifically designed for use in the
pharmaceutical, chemical and cosmetics industries.
The European Commission has launched an €11.4 million project to
identify ways of improving the production of biologic drugs and
cutting the cost of treatment.
Qiagen has launched an automated viral DNA and RNA purification
solution that provides improved sensitivity in purification and
detection of viral DNA and RNA from serum, plasma, and cell-free
body fluids.
Canada's SemBioSys Genetics has been granted a US patent on a
vaccine production system that uses genetically modified seeds as
biological factories of vaccine antigens.
Invitrogen, which supplies reagents, services and software for the
life science market, has continued its acquisitive streak with the
announcement that it is paying $35 million (€27.5m) for a UK firm -
DNA Research Innovations - specialising...
The contract manufacturing market for biologicals will more than
double over the next six years, but production costs are higher
than necessary because 'downstream' processing is being ignored.
A study performed at Tufts University in the US, commissioned by
the Nordic Council of Ministers, has downplayed the impact of the
controversial REACH legislation on the European chemicals industry.
Filtration separation specialist Pall has introduced a new filter
technology that improves the effectiveness of bioburden reduction
in pharmaceutical production and cuts costs.
Invitrogen, a provider of life science technologies, has entered
into new licensing agreements to supply its Gateway Technology and
clones to worldwide genomic research centres. This will allow
scientists and laboratories to share...
Dutch biotech firm Qiagen has announced the acquisition of key
assets of Molecular Staging (MSI), which includes the Whole Genome
Amplification (WGA) technology, designed to eliminate limitations
created by scarce quantities of DNA...
Representatives of the pharmaceutical and biotechnology industries
presented strong opposition to the concept of biogenerics at a
recent meeting convened by the US Food and Drug Administration. As
expected, their argument centred...
Italy's Marchesini has introduced a new packaging system that can
handle safety syringes, which are underused in Europe compared to
the US despite their proven benefits in reducing needlestick
injuries, reports Phil Taylor. It...
The European Union is sponsoring a new initiative aimed at
producing pharmaceuticals in genetically modified crop plants such
as maize, and hopes to start the first clinical trials of a product
by 2009. But the news has been met with...
Germany's Boehringer Ingelheim has completed the validation process
for its new biopharmaceutical production plant in Biberach with a
positive inspection by the US Food and Drug Administration (FDA).
Germany's Icon Genetics and Israeli firm Protalix are to
collaborate on a way of hiking protein expression in plant cells to
improve their use a production vehicle for recombinant proteins.
In an unusual move, Finnish science park Medipolis has set up a new
Good Manufacturing Practice (GMP) pilot plant to take advantage of
the growing demand for biopharmaceutical production capacity.
The company Evotec OAI, a drug discovery and development solution
provider to the pharmaceutical and biotechnology industries has
announced the successful expansion of their in vitro and in silico
ADMET (Adsorption, Distribution,...
Germany's Icon Genetics has published details of its proprietary
expression technology, designed to improve the production of
biopharmaceuticals and other proteins in genetically-modified
plants.
The impact on the French chemicals industry of implementing the
European Union's REACH (Registration, Evaluation and Authorisation
of Chemicals) proposals could be as high €800 million in testing
alone and lead to the loss of...
Researchers in Finland and the US have identified a gene that
predisposes people to one of the most common causes of coronary
heart disease, raising the hope that it could represent a new
target for drug treatment.
Two France-based companies have pooled their resources to set up a
new venture specialising in the contract development and
manufacturing of biologicals drugs.
Earlier this week, the US Food and Drug Administration suspended
the approval of a generic version of Pfizer's high blood pressure
drug Norvasc (amlodipine besylate) developed by India's Dr Reddy's
Laboratories. The...
Novartis' generic drugs subsidiary Sandoz has opened two new
manufacturing plants in Austria and Slovenia that mark its entry
into the contract manufacture of biopharmaceuticals using mammalian
cell culture.
Tablet-coating specialist BioProgress formalised its agreement with
US chemicals and machinery group FMC in deal that could be worth up
to $160 million (€128m) in revenues in the first six years.
The pharmaceutical industry must cut the time its drugs linger in
development and terminate less promising projects earlier if it is
to improve the efficiency and productivity of its R&D
programmes.