More than four years after Genzyme was issued a consent decree by the FDA at its biomanufacturing facility in Allston, Massachusetts, and the company is still completing its remediation efforts and will be for the years to come.
Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline.
Contract manufacturing organisation (CMO) Cobra Biologics is to produce biologics with an increased half-life using a PEGylation platform from biotech QuiaPEG.
Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.
Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.
Oncology development company Celsion will acquire Egen, a biotech company that is developing nucleic acid-based therapeutics, for $14m upfront, with the chance for more than $30m in milestone payments.
Shark antibodies survive in urea concentrations that would denature other proteins thanks to a newly discovered structure that scientists say could be used to make therapeutic mAbs more robust.
Malvern Instruments will buy GE Healthcare’s MicroCal business in a deal that adds protein analysis and formulation development tech to its expanding drug industry offering.
German CMO Rentschler Biotechnologie GmbH is adding a 2,000 L single-use bioreactor to its facility in Laupheim, Germany, which it expects to be fully operational by the end of the first quarter of 2015.
Thermo Fisher Scientific has licensed rights to gene editing technology for bioproduction applications that it claims targets DNA more precisely and reliably than current approaches.
CDMO (contract development and manufacturing organization) PacificGMP has doubled its GMP (good manufacturing practice) production capacity with the addition of a second System 1000 bioreactor platform from GE Healthcare.
Janssen has licensed the LADD immunotherapy platform and GVAX cell-line technology from Aduro BioTech in order to develop combination therapies for a number of prostate cancer candidates.
US states continue to form disparate views of how to deal with biosimilars as Delaware Governor Jack Markell (D) signed into law last week a bill that would require pharmacists to notify prescribers if a biosimilar is substituted for a biologic.
GSK will develop and commercialise Adaptimmune’s T-cell receptor (TCR) cancer therapies in a deal that could yield more than $350m (€257m) for the Oxford, UK biopharma firm.
The biotechnology and pharmaceutical bodies AusBiotech and Medicines Australia have asked the Australian Minister for Industry to invest in biopharma R&D and secure patents.
BioAtla has received a broad patent covering conditionally active biologics (CABs) and says this antibody platform could shake up the development of this new class of therapeutics.
A collaboration involving academia and industry is to develop new ways of delivering antibodies to the brain using molecular envelop technology developed by Nanomerics, a UCL spin-out company.
Ambrx says it will use its antibody platform in its collaboration with Zhejiang Hisun Pharmaceutical Company to develop and commercialise bispecifics for the treatment of cancer.
Hemispherx Biopharma announced a preliminary stage agreement with GP Pharm to manufacture Ampligen in Argentina in order to serve Latin American markets pending approval.
Roslin Cells has signed a contract with Neusentis, a research unit of Pfizer based in Cambridge, UK, to support the manufacture of retinal pigment epithelium (RPE) cells to be used in a cell therapy clinical trial.
As part of an effort to meet a rising demand for biopharmaceuticals, Germany-based Merck has agreed to invest about $68m (€50m) in its Italian production site in Bari.
The UK manufacturing sector covers all of its bases in terms of the current cell therapy manufacturing requirements and includes “a strong manufacturing base” to bring early phase academic research into the clinic, according to a survey conducted by Cell...
Novasep has made a $5.5m (€4m) investment to expand its highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France.
Novartis says stem cell-based therapies will form an important part of its pipeline after reports in the Israeli media the firm pulled out of a deal to buy Gamida Cell.
Armed with a $285m investment from the US Department of Health and Human Services – the largest of three investments -- the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM) is now using advanced manufacturing techniques...
EMD Millipore’s Massachusetts facilities will now offer upstream capabilities including media and feed screening, small-scale material production, and optimization of conditions for scale-up and technology transfer.
Teva will not form another joint venture with Lonza, but will look to purchases, partnerships and in-house developments to grow its biosimilars pipeline, say its executives.
Bayer has inked a deal with preclinical CRO Cenix BioScience to use its genome-scale RNA interference (RNAi) platform to target an undisclosed disease.
GE Healthcare Life Sciences has signed a licensing agreement for Promosome’s suite of mammalian cell line development technologies, which aim to increase protein expression in mammalian cell culture.
The latest generation of “biobetters” which are engineered to be more effective than branded biologics are hitting the market before biosimilars and could make development of the latter pointless, an expert has said.
Recent investments in antibody-drug conjugate (ADC) technology will translate into more products on the market, but it will take time says Polytherics who has extended its licensing deal with MacroGenics.
Takeda has licensed a biodegradable polymer and customisable linker platform from Mersana Therapeutics who says the tech offers advantages over other antibody-drug conjugate (ADC) approaches.
Recent outbreaks of a strain of meningitis, known as “serogroup B” or “MenB”, on US college campuses have caused both Pfizer and Novartis to develop new vaccines.
Enzyme experts trying to make the anticancer APIs vincristine and vinblastine with engineered cell lines say the technology could be used to produce a wide range of plant-derived drug actives including alkaloids like morphine.
Cell transportation technology firm Austrianova has licensed a low-cost, disposable microfluidics platform from SIMTech to improve how it dispenses cells used in biomanufacturing and therapeutic applications.
Baxter has announced plans to buy gene therapy developer Chatham Therapeutics for $70m in a deal focused on the latter’s pipeline of haemophilia candidates and gene therapy delivery platform.
Scientists at the University of Nottingham have created a new combination of hydrogels that allows dense tissue structures to be produced from human pluripotent stem cells (HPSC) in a single step process never achieved before.
French mAb developers that hire Cobra Biologics stand to benefit from tax breaks after the French Ministry of Higher Education and Research (MESR) named the CMO as a preferred provider.
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.
