Lilly’s Puerto Rico API plant issued with FDA warning letter
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.
Dishman teams with Codexis’ for cost saving enzymatic API tech
Codexis’ enzymatic biocatalysis technology offers numerous processing and cost advantages for API and chemical intermediate manufacture says Dishman CRAMS unit president Nick Green.
RecipharmCobra Biologics launches today
RecipharmCobra Biologics (RCB) launched today as a specialist biologics contract development and manufacturing organization (CDMO).
H1N1 adjuvants help SAFC in Q4; Sigma sales down in 2009
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.
Russia invests in cancer nanodrug capacity and safety
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 allies with Proteome to boost biomarker offering
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.
Cali OK for Avrio manufacturing plant
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 formulation stable after 12 months
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 stem cell production site passes building inspection
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.
Onyx invests in solid-state chemistry offering
UK CRO Onyx Scientific says that new solid state chemistry service will meet growing demand of drug industry “squeezed” by escalating R&D costs.
TTP launches contract screening service
TTP LabTech has launched a contract screening service to assist various aspects of clients’ drug development programmes, from target identification through to preclinical toxicology.
Galapagos buys Argenta to strengthen discovery services
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.
Suzhou Eyre cleared for penicillin production by SFDA
Suzhou Erye Pharmaceutical has received SFDA approval to make penicillin at its new manufacturing facility in Eastern China.
Watson buys Eden Biodesign
US generics group Watson Pharmaceuticals has bought UK contract biomanufacturing specialist Eden Biodesign.
Therapure rolls-out commercial scale lyophilisation service
Therapure Biopharma has added commercial-scale lyophilisation capacity at its facility Mississauga, Ontario in response to growing demand.