The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.
The possible sell-off of Enzon Pharmaceuticals’ biotechnology drugs business has come under fire by one of the firm’s shareholders, DellaCamera Capital Management, which says it is opposed to the move.
The PER.C6 cell culture-based antibody production platform has
achieved a new record yield of 27 grams of IgG antibody per litre,
bettering the 15 gram per litre mark that was reported earlier in
Sartorius Stedim Biotech has teamed up with Wuxi AppTec to help
companies remove some of the strain of carrying out viral clearance
testing, which for large biopharmaceutical companies can carry a
price tag of up to $1m a year.
Europe is tipped to witness the most significant worldwide gains in
biopharmaceutical manufacturing production capacity in the coming
years, despite an overall global decline in capacity utilisation by
Agilent Technologies is expanding its nucleic acid active
pharmaceutical ingredient (API) manufacturing facility in Boulder,
Colorado, US, as the industry gravitates towards the
development of oligonucleotide-based drugs.
The opening of ORF Genetics' $1m production site for recombinant
proteins in Grindavik, Iceland, is yet another groundbreaking move
by this year's winner of the Icelandic Centre for Research's
Two products aimed at enhancing the efficiency of process
development in biopharmaceutical manufacturing are the latest
offerings from GE Healthcare, the UK-based medical technology and
The use of disposable manufacturing equipment in pharmaceutical
production and greater need for containment equipment were
recurring themes at the Interphex show in Philadelphia last week,
and both were addressed by new equipment...
Syft Technologies of New Zealand released the latest generation of
Selected Ion Flow Tube-Mass Spectrometry (SIFT) instrumentation at
Pittcon 2008 for the analysis of very low levels of organic
compounds in air (detection limits as...
Bioprocessing consultancy specialist BioKinetics has unveiled a
series of online training modules designed to address skill
shortages that it says are a major issue facing
biopharmaceutical manufacturing operations.
Pharmaceutical manufacturers, distributors and retailers alike have
welcomed a unanimous vote by the California State Board of Pharmacy
to delay for another two years the implementation of electronic
pedigree requirements for tracking...
Varian, Invitrogen, BMG Labtech and Hosokawa Micron have all
recently announced new product launches, detailing a selection of
tools and equipment to aid the scientist working in the laboratory
The International Society for Pharmaceutical Engineering (ISPE) is
offering a "unique training experience" for pharmaceutical
professionals through a partnership with North Carolina State
University in the US.
The US Food and Drug Administration (FDA) has alerted the media to
the preliminary findings of its inspection of the Chinese facility
that supplied the active pharmaceutical ingredient (API) for
Baxter's heparin - now recalled...
Bayer Healthcare is to deploy a new technique, developed by
Millipore, for genetically engineering cells to produce
pharmaceutically useful proteins that could both increase the yield
and accelerate drug production.
Novartis has lent impetus to the growing trend towards
philanthropic R&D in the pharmaceutical industry by opening a
new research institute in Siena, Italy "with a non-profit
mission to exclusively focus on the development...
Genmab, the Danish antibody specialist with three product
candidates in Phase III clinical trials, is taking control of its
manufacturing requirements with the agreed acquisition of an
antibody facility in Minnesota, US for $240m...
Cellexus Biosystems, the UK company that designs, manufactures and
sells disposable cell growth technology for the biopharmaceutical
industry, is extending the rental plan offered on its CellMaker
Lite2 single-use bioreactor in response...