February 2012
Chemoswed re-certified by MPA
We have received a new GMP certificate, issued by the Swedish Medial Product Agency (MPA), based on an on-site inspection performed during December, 2011.
This is part of our regular re-certification cycle, which relies upon several-day audits performed at least every third year. The certification covers all of our production facilities, including the kilo lab, pilot plant, and main plant, as well as QC/QA and related functions.
October 2011
Chemoswed to host the 2012 Nordic Process Chemistry Forum
Chemoswed has been nominated to host the biannual process chemistry conference.
The event will take place at Arild, near Malmö, on May 23-25 2012.
Participating companies will present 30 minute case studies.
Plenary lectures will be presented by the following distinguished scientists:
Prof. Mattias Beller, Leibniz-Institut für Katalyse an der Universitet Rostock, Rostock, Germany,
Assoc. Prof. Hans Jűrgen Federsel, Pharmaceutical Development, AstraZeneca, Södertälje, Sweden,
Prof. Paul Knochel, Ludvig-Maximilians-Universität, München, Germany, and
Dr. Andrew Wells, Charnwood Technical Consulting Ltd, Loughborough, UK.
For information or registration, please inquire by email to: chemoswed@swe.dupont.com.
March 2011
Publication from Chemoswed Process R&D
Stereoselective Synthesis of Monoamine Reuptake Inhibitor NS9544.
Org. Process Res. Dev.
2011, 15, 408-412
December 2010
Chemoswed extends analytical offer
We have recently added staff to our Analytical Development and Quality Control department. The added capacity enables us to broaden our analytical services to also include certain fee–for–service packages, especially those requiring specialised equipment unavailable at many customer laboratories.
Starting 2011, we provide fixed–price packages for studies such as
- regulatory stability monitoring
- forced degradation studies, incl. photostability according to ICHQ1B
- trace metal determination by ICP-OES
- HPLC_MS development for GTI's
as well as a range of other specialised services.
Please contact us for further information.
April 2010
Chemoswed upgrades kilolab facilities with new equipment
As part of our continuous effort to integrate a complete range of process development services for our customers, we have recently installed new equipment. We have enhanced the capabilities of our kilolab by adding, to the existing 50L reactor, a 25L Büchi glass–lined multi purpose reactor. Supplemented by a Huber circulation thermostat, it allows us to operate between -40 and +200oC under full cGMP.
In addition, a new Büchi Midiclave high pressure reactor was installed, giving us the possibility to perform hydrogenations up to 60 bar pressure and 160oC, again under cGMP.
March 2010
Chemoswed extends analytical capabilities
We continue to update and extend our capabilities by adding techniques and instruments which enhance our ability to accomodate customer needs. The growing number of transition metal-assisted transformations applied within API manufacture, and an ever increasing demand to characterise also minor impurities, e. g. associated with potential genotox concerns, have triggered two recent investments.
In March 2010, Chemoswed's analytical capabilities were enhanced by the qualification of two new analytical techniques - Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) and High Pressure Liquid Chromatography -- Mass Spectrometry (HPLC-MS).
ICP-OES is a sensitive analytical technique for the detection of trace metals at ppb levels. Our instrument is a Perkin Elmer Optima 7000 DV.
Our HPLC-MS instrument is an Agilent 6110 single quadrupole carrying an electrospray ionization interphase.
November 2009
Chemoswed receives GMP approval in Japan
On November 20, 2009, Chemoswed received formal notification that our facilities and operations have been found to comply with Japanese cGMP.
The letter, received from the the Pharmaceuticals and Medical Devices Agency of Japan, concluded that "from the result of GMP compliance review against the stipulation of Article 14-6 of the Pharmaceutical Affairs Act by PMDA, there is no issue of concern".
Formal approval by the agency provides important further confirmation of our long term quality and safety work, and is valuable to our Japanese customers.
