CMO Cytovance Biologics is extending its manufacturing agreement with Precision Biologics to advance clinical trials with its leading monoclonal antibody candidate, which is being developed as a therapeutic candidate for pancreatic and colorectal cancers....
Aspyrian Therapeutics has teamed up with Goodwin Biotech to make antibody-drug conjugates (ADCs) with a technology platform that uses near‐infrared (NIR) light to activate the cytotoxin.
BioReliance has updated its big blue assay for the second time in six months by creating a version of the drug genotoxicity test that can be used in rats.
Industry group BIO has commended Indiana Governor Mike Pence for signing laws that will mean doctors must give pharmacists permission to switch a biologic for a biosimilar.
Aenova says the acquisition of Haupt Pharma and Patheon’s merger with DSM are evidence of consolidation in the CMO industry, as it looks to further increase its global footprint.
Covance has announced that its recently expanded large molecule bioanalytical space at its laboratory facility in Indianapolis will come online in late 2014.
An expression system developed by Cevec Pharmaceuticals has achieved 'very high' titres and bypassed problems that beset other platforms, moving the possibility of a commercial respiratory syncytial virus (RSV) one step closer.
Catalent has increased its stake in Redwood Biosciences telling us it is committed to the development of antibody-drug conjugates (ADCs) and the SMARTag technology platform.
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
Janssen has asked Novozymes Biopharma to help it reduce drug dosage “from daily to every two weeks or monthly” using its half-life extension technology.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
Patheon and DSM’s Pharma Products merger is “highly complementary” with crossover limited to North American oral solid manufacturing growth, says DPx as it targets further growth opportunities.
‘Podular’ manufacturing systems will dominate facility design within five years, say G-CON and GEA who have teamed with Pfizer to create a flexible, repurposable and portable facility.
When Frank Sinatra sang "If you can make it there, you can make it anywhere" in New York, New York he probably wasn't talking about biopharmaceutical production.
After making significant investments in its personalized immunocellullar manufacturing technology, Prima BioMed is looking to scale up the platform as the company’s lead product enters Phase II trials.
The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.
Patheon brings fill/finish capabilities to DSM’s biomanufacturing services, President of Biopharma at the recently merged company DPx told Biopharma-Reporter.com in an exclusive interview.
In what may be an early indication of states looking to get more involved in biologic development, EMD Millipore has won a $400,000 grant from the Massachusetts Life Sciences Center (MLSC) to fund a partnership with Promethera Biosciences.
Bayer is investing over €500m ($700m) in manufacturing recombinant factor VIII (rFVIII) products citing growing demand for long-term prophylactic treatment rather than ‘on-demand’ haemophilia drugs.
Less H5N1 influenza vaccine than expected will be available in Japan this year after downstream processing problems at a plant being set up by Daiichi Sankyo.
An analyst predicts overlap between Thermo Fisher and Life Technologies will present manufacturing, procurement and logistics cost-saving opportunities.
GE Healthcare has launched a new cell culture medium that it claims will let manufacturers skip lengthy validation steps and achieve greater batch to batch consistency.
Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.
CureVac has been awarded a grant by the European Commission (EC), which says the firm's room temperature-stable mRNA-based vaccines could overcome one of the biggest barriers to disease prevention in developing countries.
Catalent Pharma Solutions has agreed with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to advance one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans.
The EMA and US FDA say the chimeric nature of antibody drug conjugates (ADC) does not make them any harder to regulate and that existing guidelines for small and large molecule drugs are sufficient.
Proposals in President Obama’s 2015 budget to reduce the market exclusivity period for biologics could save the US $4bn (€2.9bn) but have been labelled unproductive by industry groups.
Operations will continue and may even be enhanced at DSM’s Australian taxpayer-funded biologics plant following a merger with Patheon, the Queensland Government says.
The high street of tomorrow is likely to be a mix of supermarkets, banks and biopharmaceutical manufacturing plants according to one expert who says urban drug production has significant advantages for Pharma firms and patients.
AB Sciex has launched what it claims is the first commercially available ultra-low flow electrospray ionization instrument that links CE (capillary electrophoresis) technology to mass spectrometry.
Cobra Biologics is looking for more scientists with plasmid production skills after BioCancell became the fifth firm in a year to ask the CMO to manufacture a DNA-based gene therapy candidate.
Proteomics International has agreed to collaborate with inVentiv Health to develop biosimilars and biologics, which will begin with structural and functional characterization.
Big Biopharma has backed passage of Indiana substitution laws that require doctors to grant pharmacists permission to switch a biologic for a biosimilar.
Biopharma desire to speed up the extraction and freezing process necessary for the safe transport of cell-based regenerative medicines is driving demand for cryopreservation reagents, according to biologics CDMOs.
Uptake in single-use is “off the charts” but there is still a growing market for traditional stainless steel technology, says Pall following its acquisition of ATMI.
The biosimilar market is expected to ramp up in Asia and Europe, even as it’s yet to be initiated in the US, with AbbVie, Amgen and Roche’s blockbuster biologics the most threatened, Moody's Investors Service says in a new report.
