Asterand gains GLP accreditation at UK laboratory
Asterand has gained GLP accreditation at its UK lab, enabling it to support regulatory submissions and furthering its goal of becoming a fully integrated human tissue service provider.
Covance’s R&D partnership with Lilly expands
Covance will provide US drug major Eli Lilly with bioproduct analytical testing services under an expansion of the firms’ year-old R&D collaboration.
Merck KGaA to buy Millipore for €5bn
German pharmaceutical firm Merck KGaA says proposed Millipore acquisition will transform its chemicals unit and give it a more balanced business profile.
SAFC Pharma is preparing for the shift towards cell culture-based vaccines, while still supplying and growing in the traditional sector, to ensure it can grow in coming years, according to a company director.
Sandoz opens Slovenian biosimilars production plant
Lek has opened a 430m² modified protein manufacturing facility in Slovenia to produce epoetin alfa drug substance for use in the biosimilars marketed by its parent company, Sandoz.
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.
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.
Crospon spins out transdermal patch
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.
Millipore launches Mycoplasma early-detection system
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.
Freezer-farm phase of PCT’s cell-therapy plant complete
Work on “freezer farm” phase of Progenitor Cell Therapy’s (PCTs) new manufacturing facility in Allendale, New Jersey is complete.
SurModics opens 90,000 sq ft site
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’ oral insulin shows preclinical promise
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.
AZ looks at Almac’s Flexyte platform for drug discovery
UK drug major AstraZeneca will evaluate Almac’s antibody and radiolabelling-free Flexyte kinase assay platform for drug discovery operations.
Cambridge Consultants “invaluable” in deal says Consort Medical
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 buys MRT for mini MTPD technology
Pall says its acquisition of MicroReactor Technologies (MRT) broadens its offering in the $1bn (€689m) a year global biopharmaceutical process development market.
Novavax scales up RSV-F vaccine
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.
Jubilant partners to expand GPCR screening services
Jubilant Biosys has entered into a co-marketing agreement with DiscoveRx, expanding the companies’ screening services and geographic reach.
Genzyme strengthening its quality team and appointments at ISPE and Biogen Idec – People on the move
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.
Florida Biologix expands bioreactor and fill capacity
A recently completed manufacturing and filling capacity expansion will help Florida Biologix meet deadlines and win repeat business according to company director Richard Snyder.
Insect cells could cut vaccine production to 10 weeks
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.
MPI and Bioject form needle-free pact
US preclinical CRO MPI Research has formed an alliance with Oregon-based needle-free delivery specialist Bioject Medical Technologies.
InNexus developing topical psoriasis treatment
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 & Selexis partner to speed production of biologics
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.