Drug manufacturers that change hard gelatin capsule suppliers do not need to seek approval beforehand under a policy introduced by the US FDA this week.
There will be no major changes in the short term after the “surprise” decision by the EC to drop the directive about some excipients having to comply with GMP, according to a freelance consultant.
French diagnostics and microbiology firm bioMerieux claims its new range of indicator medias will help drugmakers cut testing times and reduce errors during GMP mandated sterility analysis.
Denmark's Novozymes has set up a dedicated business unit in the UK
to make and sell ingredients that support companies wanting to
produce biopharmaceuticals without using animal-derived
constituents.
Specialty chemicals firm Cognis has received good manufacturing
practice (GMP) certification for its production of pharmaceutical
excipients in Germany, the first chemical company in the world to
do so but certainly not the last.
Invitrogen has opened a bioproduction facility in Australia to make
bovine sera products and reagents used in basic research and the
production of vaccines and biotherapeutic drugs.
Celliance has introduced a new bovine albumin product, manufactured
exclusively from animals originating in Australia, that is aimed at
applications such as pharmaceuticals where there is a need to
ensure the absence of transmissible...
Recently-formed cell culture specialist Celliance has introduced a
new supplement designed to boost the growth of cells used in
research and bioprocessing, that does not contain fetal bovine
serum.
The emergence of cases of mad cow disease in North America has not
raised any public health concern from animal-derived medicinal
materials such as bovine blood derivatives and gelatin.
US company STERIS has achieved a significant breakthrough in
aseptic processing with the development of a method for
inactivating prions, the tiny, protein particles that cause
diseases such as CJD disease in humans.
Researchers have taken a step forward in the development of a
system for making unlimited quantities of antibody-based drugs for
human applications in cattle.