Manufacturing: Page
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Brammer Bio doubles manufacturing capacity at Florida site
Completion of the expansion should help the gene therapy CDMO better support early-stage clinical trials.
By Ned Pagliarulo • Sept. 21, 2017 -
Fujifilm opens new mammalian cell facility
The 10,000-square-foot facility expands the Japanese firm's footprint in the U.K.
By Jacob Bell • Sept. 14, 2017 -
FDA calls for industry input on continuous manufacturing guidelines
Biopharmas largely haven't adopted the speedier and more adaptable approach to drug manufacturing, relying instead on tried-and-true batch production methods.
By Ned Pagliarulo • Sept. 14, 2017 -
NYC's research lab construction market is heating up
The city's 1.7 million square feet of lab space is fully occupied, with little new space in the works.
By Mary Tyler March • Sept. 12, 2017 -
Pfizer's EpiPen manufacturer warned by FDA
The agency found glaring issues with how the site handled quality control, complaints and defective auto-injectors.
By Jacob Bell • Sept. 8, 2017 -
FDA
Integration a key focus of FDA's new drug review model
Agency head Scott Gottlieb plans to create more integrated teams to boost information sharing between staff scrutinizing new drugs and those reviewing manufacturing facilities.
By Jacob Bell • Sept. 7, 2017 -
Cell therapy emergence opens up new markets for shippers, logistic companies
Companies like GE Healthcare and Cryoport have expanded their capabilities to help solve the challenges of preserving and shipping patient cells.
By Ned Pagliarulo • Sept. 7, 2017 -
Hospira recalls 5 lots of injectable drugs over sterility concerns
Similar worries were behind a June recall of sodium bicarbonate.
By Suzanne Elvidge • Sept. 7, 2017 -
OpinionThe digitalization productivity bonus in pharma manufacturing
Digitalization and data analytics can help companies in the sector reduce the high levels of downtime typically experienced by pharmaceutical plants.
By Chris Wilkinson • Aug. 31, 2017 -
FDA hits yet another Indian drugmaker with warning letter
Following a December inspection, the agency determined equipment maintenance and quality controls at a Hetero Labs manufacturing facility were inadequate.
By Jacob Bell • Aug. 31, 2017 -
FDA warns Florida stem cell clinic about GMP deviations
The FDA has warned U.S. Stem Cell Clinic about a host of issues, including violations of GMP.
By Suzanne Elvidge • Aug. 31, 2017 -
Landmark approval won, Novartis' next test is scaling CAR-T manufacturing
Treating patients with the pioneering cell therapy will require reliably transporting human cells through a complex logistics chain.
By Ned Pagliarulo • Aug. 31, 2017 -
US, EU advance collaboration efforts on manufacturing
The FDA has agreed to share more complete confidential information per the terms of a freshly inked agreement with other regulatory bodies.
By Jacob Bell • Aug. 24, 2017 -
Micro-Sphere expands facility in Switzerland
Increased demand in dry-powder formulations has pushed the CDMO to expand its manufacturing capabilities.
By Lisa LaMotta • Aug. 24, 2017 -
Novo manufacturing subsidiary completes Budapest expansion
Xellia Pharmaceuticals has a new 32,000-square-foot facility to boost its anti-infective production capabilities.
By Jacob Bell • Aug. 24, 2017 -
Sponsored by Pfizer CentreOne
The value of the embedded-CMO model
Should you consider a CMO’s operating model when choosing a manufacturing partner? Read about the value of the embedded CMO, and why Pfizer chose that model for its contract manufacturing business, Pfizer CentreOne.
Aug. 24, 2017 -
Oxford Genetics tags new funding for US, UK expansion
With a £7.5 million investment in hand, the synthetic biology company plans to build out its cell engineering and vector production capabilities.
By Suzanne Elvidge • Aug. 24, 2017 -
FDA
Valeant says FDA to reclassify troubled Tampa plant
Such action should help eliminate regulatory uncertainties for products manufactured at the site, according to the Canadian drugmaker.
By Ned Pagliarulo • Aug. 17, 2017 -
FDA flags drugmaker's testing of potentially poisonous powders
The agency took a dim view of Homeolab USA's manufacturing processes, including those for its belladonna-containing powder blend.
By Jacob Bell • Aug. 17, 2017 -
GSK opens £44M aluminum salts facility in Scotland
With the expansion, the British drugmaker will be able to supply the key ingredient for 70% of its vaccines portfolio.
By Suzanne Elvidge • Aug. 17, 2017 -
Biocon pulls EU application for Herceptin biosimilar
The European Medicines Agency informed Biocon it would need to re-inspect the Indian manufacturer's drug product facility, triggering the withdrawal.
By Suzanne Elvidge • Aug. 17, 2017 -
PharmaTech liquid drugs possibly contaminated, FDA says
One distributor, Rugby Laboratories, has already announced a recall of two liquid docusate products manufactured by PharmaTech.
By Ned Pagliarulo • Aug. 10, 2017 -
England starts prioritizing patients amid global hep B vaccine shortage
The decision comes as Merck and GSK work to restore vaccine supplies.
By Jacob Bell • Aug. 10, 2017 -
Pfizer to invest $100M in build-out of gene therapy site
Pfizer acquired the Sanford, NC-based facility as part of its $645 million acquisition of Bamboo Therapeutics last year.
By Suzanne Elvidge • Aug. 10, 2017 -
Manufacturing issues threaten delay for Aerie eye drug
But Aerie believes the issues at its third party manufacturer's facility will be resolved before the expected decision date for its glaucoma med Rhopressa.
By Ned Pagliarulo • Aug. 10, 2017
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