Antibody Drug Conjugate Development and Manufacture
Piramal
Possible API Contamination at Chinese CMO Leads to Canadian Recalls
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Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO. Related news |
News in brief
GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
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.
Exclusive interview
Quintiles’ Lead Medical Expert: Real World Patient Data Hold Enormous Potential
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 Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
Global Industry News
Bioartificial Liver Project Looks to Disposable Bioreactors for Large Scale Cultures from in-PharmaTechnologist.com
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.
Impax Hires Specialists to Help Sort Manufacturing Issues from in-PharmaTechnologist.com
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 from in-PharmaTechnologist.com
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.
Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing from in-PharmaTechnologist.com
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.
US House Bill Aims to Expand Release of Clinical Trials Data from in-PharmaTechnologist.com
US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Hot topics
Spotlight
  Executives Raise Questions on Clinical Trial Sponsors’ Oversight of CROsTension between clinical trial sponsors and CROs in terms of CRO oversight may not be relieved any... |