The US FDA has issued a warning letter to Czech API manufacturer VUAB Pharma for failing to properly respond to microbiological contamination and data integrity issues.
The world’s top pharma and biologics manufacturing and processing companies have come together in New York this week to showcase the latest in equipment and services.
Following a May 2014 inspection, US FDA officials have issued a warning letter with multiple cGMP (current good manufacturing practice) deficiencies for Hospira’s manufacturing facility in Liscate, Italy.
The tightening federal budget is increasing competition between research institutes and academia when it comes to preclinical toxicology testing, according to MRIGlobal.
Amid ongoing efforts by the US FDA to crack down on foreign suppliers not meeting cGMP (current good manufacturing) requirements, India-based Sun Pharma is the latest company to be hit with a warning letter.
Biopharma firms, particularly those producing insulin and five of its analogues, have another option in the market of sub-2 micron solid-core chromatography columns with a recent offering from Waters.
In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company downplayed the impact of the letter and said it won’t create...
Dr. Reddy’s may not have as big a hill to climb as some observers suggest to regain customers lost as a result of the closure of its Mexican API plant, according to Barclays.
SAFC has coupled its chiral screening and small-scale purification services to meet what it says is a boom in demand for more complete chemical analysis from drugmakers.
CMO Richter-Helm BioLogics has achieved a 60 per cent increase in yield using technology from Upfront Chromatography, which demonstrated its system at BIO 2009.
CiVentiChem president Bhaskar Venepalli says that the CiVentiAnalytical unit, the firm’s new state of the art GLP/cGMP accredited laboratory in Cary, North Carolina, will help customers find novel method development solutions for API production.
Active pharmaceutical ingredient specialist Calyx Chemicals and Pharmaceuticals is planning an acquisition within the next two years, probably in the US or Europe, according to chief executive Smitesh Shah.
UK-based polymer technology specialist Chromatide and Akzo Nobel's Separation Products (SP) unit are teaming to develop a HPLC media for purification applications in the drug manufacturing industry.
Two products aimed at enhancing the efficiency of process
development in biopharmaceutical manufacturing are the latest
offerings from GE Healthcare, the UK-based medical technology and
services company.
Waters Corp unveiled a new concept in Process Analytical Technology
(PAT) at Pittcon 2008 when it released the new Patrol UPLC (ultra
performance liquid chromatography) process analyser, which can be
incorporated directly into a process.
ProMetic's purification technology has been implemented in a
large-scale biomanufacturing process with an undisclosed client for
a product that will be used in clinical trials.
PerkinElmer has expanded its multi-vendor service offering to help
firms reduce the cost of regulatory compliance in pharmaceutical
drug development and manufacturing quality control laboratories.
LabTechnologist.com brings you an exclusive interview with Chris
van Ingen - the president of Agilent's Life Science and Chemical
Analysis (LSCA) division.
A new range of preparative scale supercritical fluid chromatography
(SFC) and extraction (SFE) products promises cheaper and faster
separations and extractions.
PerkinElmer has released its line of gas chromatography products,
which claims to deliver the fastest injection-to-injection time in
conventional gas chromatography, reducing cycle time and increasing
sample throughput.
Looking to expand its laboratory testing and consulting services,
PharmEng has acquired Rootlink Tecknic, a laboratory
instrumentation automated solution sales and service company based
in Toronto.
Agilent has launched a new line of HPLC columns, which is set to
deliver industry-leading separation performance for analytical,
high-resolution and fast LC applications, including pharmaceutical,
QA/QC, environmental and food-safety...
Agilent Technologies have upped the stakes in the Liquid
Chromatography (LC) market by releasing its new 1200 series,
replacing the best selling 1100 series with what is claimed to be
the world's fastest and most comprehensive...
A new class of chiral stationary phases (CSPs) for analytical and
preparative-scale high performance liquid chromatography (HPLC),
has been launched by ZirChrom Separations, which further enhances
HPLC as a method of choice for chiral...
According to a recent report, analytic separation technology will
continue to evolve as limitations are addressed and standards grow
even more rigorous, as market drivers such as quality control,
instrument design, and software in...
Varian has announced it is to acquire Polymer Laboratories for $42
million (€35.7 million)in a transaction that adds consumables and
instrumentation for Gel Permeation Chromatography (GPC) analysis to
its product portfolio.
Chemical analysis specialists, Metrohm, have introduced its latest
ion chromatography system, which enables Gentamicin determination
without the complex set up that is characteristic of the current
HPLC method.
Researchers have developed a unique approach that predicts protein
separation behaviour. The approach may reduce the time it takes to
bring pharmaceuticals to market and may have significant
implications for drug discovery.
Researchers at Rensselaer Polytechnic Institute in the US have
developed a method to predict protein separation behaviour -
directly from protein structure - that could reduce the time it
takes to bring pharmaceuticals to market.
