The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
Codexis’ enzymatic biocatalysis technology offers numerous processing and cost advantages for API and chemical intermediate manufacture says Dishman CRAMS unit president Nick Green.
Revenues fell 3 per cent in 2009 at SAFC but pharmaceutical sector demand for vaccine manufacturing products helped firm finish year with six months of growth.
Rusnano, the group set up to promote Russia’s nanotechnology infrastructure, says nanodrug development partnership will improve patient access and cut cancer death rates across the country.
Parexel has formed an alliance with Proteome Sciences to enhance its biomarker capabilities, allowing it to help clients make earlier assessments of new compounds in development.
US CDMO Avrio Biopharmaceuticals’ new aseptic fill-and-finish facility in Irvine, California has been approved for the manufacture of biologics by state drug regulators.
MDRNA’s liposomal drug delivery formulation, DiLA2, lost no potency when stored for 12 months in conditions ranging from -80ºC to 4ºC, helping to validate it for administration of UsiRNA.
ISCO’s stem cell manufacturing facility has passed final building inspection, enabling it to implement the processes and cGMP standards needed to produce clinical-grade products.
TTP LabTech has launched a contract screening service to assist various aspects of clients’ drug development programmes, from target identification through to preclinical toxicology.
Belgium-based Galapagos NV has acquired Argenta Discovery for €16.5m ($23.1m), creating a drug discovery service company with 390 employees and estimated revenues of €70m.
Crospon has spun out its transdermal controlled release patch into a distinct company, two years after it licensed the system from HP, using funding from a pharma firm to further its development.
Detection of Mycoplasma contamination in biologics manufacture can be cut from up to 35 days to four hours using Millipore’s MilliPROBE, according to the company.
SurModics has opened a 90,000 sq ft cGMP manufacturing and development facility in Birmingham, Alabama, US to support its partnerships and shorten time to market.
Access Pharmaceuticals’ insulin diabetes treatment has shown promise in preclinical trials, achieving over 80 per cent oral bioavailability, leading the company to target proof-of-concept studies in humans.
Cambridge Consultants (CC) says experience developing auto-injector technologies was critical to its contract appraisal work during Consort Medical’s £16.8m (€11.5m) takeover of The Medical House (TMH).
Pall says its acquisition of MicroReactor Technologies (MRT) broadens its offering in the $1bn (€689m) a year global biopharmaceutical process development market.
Novavax has completed cGMP scale up of its RSV-F vaccine candidate, with the material being used in preclinical studies, and amended the terms of the H1N1 collaboration with Xcellerex.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Genzyme strengthening its quality team and appointments at ISPE and Biogen Idec.
A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.
Vaccines could be produced in less than 10 weeks from first isolation of the RNA sequence by using insect cell derived influenza VLPs, according to research which has implications for H1N1 and H5N1.
InNexus Biotechnology believes 2010 is the year for biotechs to differentiate and has begun this process by using its Transmab delivery technology in a product for treating psoriasis.
Laureate Pharma and Selexis SA have entered into a joint-marketing relationship, drawing on their respective strengths in contract manufacturing and cell line development to shorten timelines.
