Amgen has completed construction of its first $200m next-gen biomanufacturing facility in Singapore, which is outfitted with single-use technology to allow for greater flexibility.
Single-use continues to be adopted by the bioprocessing industry, but drugmakers are still hesitant to use disposable chromatography systems, says EMD Millipore.
Turkey’s efforts to increase local biopharmaceutical production have prompted GE Healthcare Life Sciences to set up a biopharmaceutical technology training centre in Istanbul.
The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.
Extractables & leachables are the number one problem holding back the adoption and scale-up of single-use technology, according to a WuXi Apptech Director.
Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.
Personalized immunotherapy developer Argos Therapeutics has broken ground on a new 100,000 square-foot biomanufacturing facility in Durham, North Carolina.
Close relationships between vendors and biomanufacturers are critical according to Sartorius, which was been awarded an accolade for the design of WuXi AppTec’s biologics production facility in China.
As single-use technology replaces traditional stainless steel technology in biomanufacturing, suppliers will own a larger portion of the supply chain, which is creating anxiety for end users such as Pfizer and Merck, experts say.
Increased efficiency, local manufacturing and specialty products are driving demand for smaller more flexible facilities, according to bioprocessing consultant Howard Levine.
Biomanufacturing costs and the risk of extractables and leachables can be reduced by developing more compatible plastics, Sabic told Biopharma-Reporter.com at CPhI in Paris.
Making active pharmaceutical ingredients (API) is a dirty business and you’d have to be pretty green to believe claims drug industry 'demand' will create a $100bn market for environmentally-friendly production methods by 2020.
Life science sector consolidation is a concern for some biomanufacturers, who say mega mergers like Merck KGaA’s $17bn acquisition of Sigma-Aldrich will limit their ability to negotiate on prices.
Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.
Common environmentally practices for single-use systems must be adapted before industry “becomes too set in its ways,” says Greenpeace, despite biocontamination currently impeding recycling efforts.
The environmental impact of single-use biosystems remains lower than stainless steel despite difficulties in the disposal of bioreactor bags, says Sartorius.
Merck Millipore has set out to win more biomanufacturing business in Japan by consolidating testing and technical operations in the country into a newly expanded Tokyo training hub.
Oncology-focused Progenics Pharmaceuticals has selected CMO Gallus BioPharmaceuticals to manufacture the anti-prostate specific membrane antigen (PSMA) monoclonal antibody used in Progenics’ PSMA ADC product candidate.
Miltenyi Biotec has acquired the lentiviral vector manufacturing business and related assets from Lentigen, a lentiviral technology provider for cell and gene therapy applications.
Carbogen Amcis has expanded its operations in light of unrelenting demand for antibody-drug conjugate (ADC) services by signing a long-term lease for a facility in Switzerland.
Redbiotec has selected GE Healthcare’s single-use processing offering to aid development of its Herpesvirus vaccines which use viral antigen complexes and virus-like particles.
Sartorius Stedim Biotech has attributed strong sales and order growth in the second quarter 2014 to recent acquisitions and demand for single-use products.
Biologic manufacturer PlantForm and PharmaPraxis have established a joint venture to develop, manufacture and commercialize biosimilar versions of six key biopharma treatments.
Interest in creating alternatives to Protein A has waned in light of more viable cost-saving opportunities in bioprocessing, such as single-use adoption, says Repligen.
A new UK “biologics facility of the future” (FoF) testing centre will let biopharma tech firms develop smaller-scale manufacturing systems for personalised medicine production according to the Centre for Process Innovation (CPI).
Protein A will keep its key role in therapeutic mAb production but next generation biotherapeutics will see Protein L become increasingly import says GE Healthcare.
Lonza has invested in single-use technology at its Swiss clinical manufacturing facility citing a rise in demand as customer’s grow their antibody-drug conjugate (ADC) pipelines.
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.
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.
Repligen has added the “gold standard” of fermentation cell retention technology to its portfolio, and says it will develop it further to support the rise in single-use.
Janssen has mirrored Pfizer’s concerns about the scale, price and robustness of using single-use technology for high-volume production but says industry collaboration could help bring standards in place.
Single-use technology for high volume biomanufacturing is riddled with problems and will only be fully implemented by industry once the cost drops, according to Pfizer.
Dispatches from the Biological Production Forum, Dublin
Though industry has fully embraced single-use, manufacturers of such systems need to remove the risk of extractables and leachables and control the supply process according to Sartorius.
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...
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