Biopharma is ramping up the outsourcing of some of the easier tests while tasks such as downstream process development and QbD services are being outsourced less, according to a new survey.
Increased demand for mammalian technologies will boost Lonza further when a new Swiss facility comes online offering “unique” complete development and manufacturing ADC services, the firm says.
SAFC (Sigma-Aldrich Corporation) says it will invest across its life science businesses following a first quarter that saw “weak” contract manufacturing but flourishing viral and cell media sectors.
A ‘spinning membrane’ technology could provide an automated solution to the manual problem of cell washing in both upstream and downstream processes says Fresenius Kabi.
Bristol-Myers Squibb and Samsung Biologics have expanded their existing agreement in which Samsung will manufacture several unnamed biologics at its Incheon, South Korea manufacturing site. Financial terms of the agreement were not disclosed.
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.
Q1 revenues for Thermo Fisher’s Life Sciences Solutions business shot up 384% year-over-year in a quarter that saw the integration of Life Technologies.
As the race to develop mAbs (monocolonal antibodies) heats up and companies vie for the elusive seven years exclusivity that comes with an orphan drug designation, the US FDA is now offering guidance on when two mAbs should be viewed as the same.
The US Food and Drug Administration (FDA) has approved a second “Breakthrough Therapy” biologic but it is still unclear whether the programme speeds drugs to market, says an expert.
Aastrom Biosciences will pay Sanofi $6.5m (EUR4.7m) for its cell therapy business in a deal that gives the cash strapped regenerative medicines developer three commercial products.
Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.
Catalent will provide Hisun Pharmaceuticals with cell lines to help it develop infliximab, adalimumab and alemtuzumab biosimilars for the Chinese market.
Cell therapy developer NeoStem has agreed to acquire California Stem Cell in a deal worth up to $124M, and includes CSC’s manufacturing facility in Irvine, CA.
Development of new anti-choloesterol drugs containing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibiting monoclonal antibodies could double Repligen Bioprocessing’s earning power, according to a Jefferies analyst.
Stem cell company ReNeuron will move its operations and headquarters to Cardiff, UK after leasing an R&D and manufacturing facility from the Welsh government.
The US agency that oversees biologics approved eight vaccines for diseases ranging from influenza to Japanese encephalitis in 2013 according to a new report.
The High Court in London has revoked two patents referring to the dosage and composition of Roche’s monoclonal antibody drug Herceptin, paving the way for Hospira’s biosimilar product.
The US agency that oversees biopharmaceuticals will continue to assess lot release samples for approved productions but BLA review timelines may be impacted by its move to a new HQ in Maryland.
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.
Northwest Biotherapeutics, which is developing personalized immune therapies for brain cancer patients, has raised $32m to fund expansion of its manufacturing operations in Europe.
Despite the director’s resignation, the US NIH Intramural Center for Regenerative Medicine (CRM) has not closed and will hold a workshop to guide the direction of the center’s future, the NIH told us.
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.
Small-sized Australian biopharma developers will be able to use a GMP cell line contract manufacturing facility operated by Patheon Biologics (formerly DSM Biologics) as a result of a AUS$2m (US$1.8m) grant fund.
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.
Revising the regulations that govern gene and cell therapies - known as advanced therapy medicinal products (ATMPs) - will increase the number of marketing authorisation applications for such products and attract more Big Pharma involvement according...
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.
Adaptimmune has selected Biolife’s cryopreservation media for its genetically modified T-cell receptor (TCR) product citing its ability to retain viability and potency.
As Celltrion anticipates applying for US FDA approval for its Remsima biosimilar in the first half of 2014, the company this week filed suit in US District Court in Massachusetts against Janssen seeking to invalidate patents that would stop such a launch.
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.
Novasep has reported a 14 percent growth in its biopharma business driven in part by demand for downstream manufacturing and its continuous chromatography systems.
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.
In direct opposition to a petition raised by GPhA (Generic Pharmaceutical Association) and Novartis, AbbVie, Genentech and Amgen are all looking for the US FDA to call for new non-proprietary names for biosimilars.
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.
Researchers are developing a cellulose filter paper they claim is at least as effective at removing viruses from biopharmaceutical production streams as currently available industrial systems.
GSK’s Eperzan (albiglutide) has become the first approved drug to use the Veltis half-life extension technology and, according to Novozymes, may make it a strong competitor in the GLP-1 agonist market.
In light of the implementation of the Drug Quality and Security Act of 2013 in the US, which calls for the phased implementation of electronic tracking down to the package level, companies are looking at options to catch up and reduce counterfeiting at...
IFPMA will advocate for all biologics to have a qualifier added to their names at the WHO’s INN Consultation on April 8, the biologics giant Amgen has told BioPharma-Reporter.com.
