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ATMI Life Science
Bioartificial Liver Project Looks to Disposable Bioreactors for Large Scale Cultures
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Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure. Related news |
News in brief
Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
DISPATCHES FROM INTERPHEX
New DFS Unit Built on Technology, R&D and Manufacturing, says Capsugel
Following a busy few months, Capsugel spoke about the formation of its Dosage Form Solutions Unit, its technology and the integration of Encap at this year's Interphex in New York.
Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions after the first Form 483.
Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
Global Industry News
Possible API Contamination at Chinese CMO Leads to Canadian Recalls from Outsourcing-Pharma.com
Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
Aspen & Local CMOs to Benefit from GSK's Aus Packaging Plant Closure from Outsourcing-Pharma.com
GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
Exclusive interview
Quintiles’ Lead Medical Expert: Real World Patient Data Hold Enormous Potential from Outsourcing-Pharma.com
Supplementing prospective randomized, double-blinded clinical trial data with real-world patient data holds “an enormous amount of potential” for CROs and trial sponsors, according to an expert.
ADC Bio Expands Lab Services in Response to Demand from Outsourcing-Pharma.com
ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
Dispatches from Interphex
TFS Sees Increase in Modularization, Shorter Construction Timelines from Outsourcing-Pharma.com
Biopharma companies are looking for more pre-fabrication of their facilities and to be able to expedite construction and meet tighter timelines, an expert told Outsourcing-Pharma.com.
Spotlight
  Dispatches from Excipient Fest in Baltimore - UPDATEConfusion Abounds in Elemental Impurities Testing for Pharma, ExcipientsAs the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and... |
 Dispatches from Excipient Fest in BaltimoreChina Looks to Tighten Excipient Regulations with Limited ResourcesChina’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have... |
 Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for PfenexInjex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax... |
 GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020... |