Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.
The Research Institute for Chromatography (RIC) and Anacura have joined forces to create anaRIC biologics, an R&D and GMP analytical specialist CRO for biologics.
Danaher Corporation will further extend its presence in the life sciences space through the acquisition of separations and purification firm Phenomenex.
A host of recent small deals, expansions, office openings and other news from CDMOs (contract development and manufacturing organizations) and CROs (contract research organizations) around the world.
CDMO (contract development and manufacturing organization) Aptuit is investing in additional scale and capabilities at its Italian site to augment its 1600L scale API capability and to add a commercial GMP license.
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.
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.
in-PharmaTechnologist presents a roundup of recent ingredient and formulation research, including improved API impurity detection and a simple step to boost stability.
WuXi AppTec is to use ThalesNano’s H-Cube for laboratory-based hydrogenation, which the CRO believes offers advantages in drug discovery over traditional batch processes.
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.
French firm Novasep has significantly boosted its ability to provide customers with enantiomerically pure compounds with the addition of a new chiral chromatography unit.
UK-based Melbourn Scientific is now offering an integrated package of formulation, method development, analysis and short-run clinical manufacture services to industrial clients.
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.
UK-headquartered ESA Biosciences has unveiled a new system for the identification of low levels organic impurities during the production of active pharmaceutical ingredients (API).
Midas Pharma and Capsulution NanoScience have entered into a long-term cooperation agreement, with contract manufacturing capacity and other services being provided in exchange for access to drug delivery technology.
Agilent Technologies has licensed BIA Separations' bio-monolithic
technology and intends to use it in the commercialisation of
analytical high performance liquid chromatography (HPLC)
bio-monolith columns.
ESA Biosciences has struck a deal with Waters Corp to produce a
direct interface for ESA's HPLC detector that allows it to fully
integrate with Waters' chromatography control and data-analysis
platform.
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.
Pfizer Japan is cleaning out its closet, selling a range of its
"surplus" biotech and pharmaceutical lab equipment via an online
auction, a method that is slowly catching on in the country.
Waters posted an 11 per cent yearly sales increase on the back of
increasing demand from the pharmaceutical industry, generic houses
and outsourcing laboratories.
Agilent Technologies has signed an agreement with Groton Biosystems
to co-market measuring solutions for the pharmaceutical industry,
as the Process Analytical Technology (PAT) initiative gains
popularity among drug manufacturers...
Varian makes available its new HPLC columns that are designed for
use in the pharmaceutical industry, particularly in pre-clinical
development, increasing productivity by enabling more products to
be purified in less time.
French purification specialist Novasep has unveiled a new series of
preparative high-performance liquid chromatography (HPLC) columns
that are ideally suited for the purification of any amount of
product.
French separations specialist Novasep has launched two new
chromatography systems, promising new levels of efficency in
preparative high performance liquid chromatography (HPLC).
As the threat of new viruses like avian influenza have heightened
the need for greater speed and safety in vaccine production, single
use technologies are proving far more safe and economic than
traditional cleaning techniques, according...
Analytical technology specialists Waters Corporation and Bruker
BioSciences have entered into a collaboration agreement to provide
greater integration and connectivity between their products,
looking to increase efficiency in pharmaceutical...
Agilent's breakthrough HPLC-Chip technology forms the basis of its
new reusable microfluidic chips, designed to compliment the
company's high performance liquid chromatography (HPLC) chip/mass
spectrometry (MS) modules.
Novasep Process launches its latest Supercritical Fluid
Chromatography unit, which aims to cut time and operating costs by
incorporating an automated CO2 recycling feature making it suitable
for purification process development, laboratory...
Peakdale Molecular and Dynamic Extractions are to collaborate on
the development of a new separation technology with applications in
drug discovery, development and manufacture.
A new way of ensuring that pharmaceutical production lines are free
of cleaning agents has been developed by Smiths Detection and Dober
Group, reports Phil Taylor.
Lonza is planning a major exansion of its peptides manufacturing
capacities at Visp, Switzerland, in response to what it said was
'the increased demand for peptide active pharmaceutical ingredients
worldwide'.
Thermo Electron has introduced a high performance liquid
chromatography (HPLC) system - the Finnigan Surveyor Plus - for
high-throughput sample processing.
Varian has announced the availability of new software that enables
automated high performance liquid chromatography (HPLC) method
development and validation. This increase in sample throughput
makes it suitable for pharma and biotech...
Microfluidics company Nanostream has introduced a new range of
cartridges designed specifically for quantitative applications such
as solubility assessment and dissolution testing using its micro
parallel liquid chromatography (mPLC)...
ESA has introduced what it claims is the first true universal
detector for use with high performance liquid chromatography
(HPLC), a based on a technology called CAD (charged aserosol
detector).
