The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.
The company is increasing manufacturing capacity at its Copenhagen, Denmark facility with the addition of six new bioreactors.
As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.
A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.
Alcami and the University of North Carolina Wilmington received a grant from the National Institute for Innovation in Manufacturing Biopharmaceuticals to prepare students for careers in pharmaceutical sciences.
The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
Girish Malhotra argues in CPhI Annual Report that shorter approval times and financial incentives are needed to promote manufacturing improvements.
Flush solutions for liquid chromatography mass spectrometry (LC-MS) systems and ultrapure solvents for ultra-high-performance LC-MS systems from Thermo Fisher Scientific can minimize interference and maximize lab instrument uptime.
Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).
Shimadzu’s Imagereveal MS mass spectrometry imaging data analysis software can analyze large sets of data or simultaneously analyze multiple sets of data.
The acquisition strengthens Nelson Labs’ outsourced testing capabilities for the pharmaceutical and medical device industries.
PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.
The TSQ Fortis Triple Quadrupole Mass Spectrometer from Thermo Fisher Scientific offers fast, robust liquid chromatography-mass spectrometry (LC-MS/MS) analysis for clinical research laboratories.
The Lumis electron backscatter diffraction (EBSD) detector incorporates a large-format complementary metal oxide semiconductor (CMOS) sensor to enable higher sample throughput, higher resolution measurements, and precise phase identification.
The company’s new electron microscopy and microanalysis solutions offer scientists enhanced research capabilities.
Bristol-Myers Squibb appointed a new executive vice-president and chief commercial officer from within the company, effective immediately.
The company is certified as a manufacturer of pressure vessels and components for use in China.
The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
An expansion of laboratory facilities in Geneva, Switzerland expands SGS services for high-order structure analysis.
Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.
The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.
The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
The acquisition will strengthen Astellas Pharma’s position in ophthalmology.
