Latest news from Syntagon

January 2012
Syntagon enters a collaborative agreement with world class QA expert George Köllner

 

We are very happy to announce a great addition to our QA and regulatory team: Syntagon has entered a collaborative agreement with George Köllner – a world class Quality Assurance expert. George brings more than 20 years of experience from pharma industry. George has held a position of Director of Quality Assurance at AstraZeneca where his major focus has been leading the development and implementation of modern Quality Assurance systems in API Process Development.

”I am very excited having George on our team, it will allow us to better serve our customers by strategically setting the quality levels best suited for the project and thus avoiding costly delays”, says Ulrika Burén, Syntagon QA Officer.

In addition to serving the GMP projects George’s expertise will also be available as a stand-alone service – from quality consulting to setting up internal quality systems and performing external audits.
We are confident that this addition will strengthen our strategic direction of an improved service quality at Syntagon
 

Syntagon offers higher quality service

Syntagon is very excited about being able to increase the level of quality it provides.

We see that the regulatory requirements for clinical materials are becoming more demanding, and we see more and more later stage - Phase II and III projects, which are more quality demanding. Our approach is simple – we at Syntagon will do what we have always done – we will put our customer’s needs first, and we will restructure our company to increase the levels of quality of services we provide.

Our Swedish site will focus on regulatory support and quality assurance as well as customer relations and project management. The plant where the products are manufactured and the manufacturing support team will also remain in Sweden. In Latvia we will focus on clinical development of production methods for drug substances, quality control and preclinical supply.
The result of these changes will be a significant increase in the quality of services and we will be able to provide this quality at the same price as today.
 

October 2011
Syntagon announces changes in leadership

Syntagon has unveiled key changes to its management team. With immediate effect Dr. Andis Slaitas will replace Dr. Michael Lofthagen as CEO of Syntagon. Andis has been with Syntagon since 2005 and was instrumental in developing the Syntagon Baltic site, based in Latvia. Prior to this promotion Andis was VP of operations at Syntagon. In additon Ulrika Burén has been promoted from QA associate to QA officer.

September 2011
Syntagon to exhibit at CPhI (ICSE) on October 25th-27th

Syntagon will be exhibiting and presenting at CPhI (ICSE) in Frankfurt, Germany on October 25-27th.  Join Syntagon's Technical Director, Dr. Anders Högdin, and discover why Syntagon is the only company that can offer CMC(s) Approval Guaranteed.  Dr. Anders Högdin will be presenting at 1pm on Tuesday, October 25th at the ICSE Speakers corner in Hall 4.1.  Make sure to stop by Syntagon's booth stand at 41G66 in Hall 4.1 anytime during the show.  Click Here for More Information.

August 2011
Syntagon to attend the 2011 Biotech Outsourcing Strategies (BOS) show on September 20th

 

Syntagon will be attending the 2011 Biotech Outsourcing Strategies (BOS) show at the Royal College of Physicians in London on September 20th. 
 
BOS 2011 is the leading outsourcing-focused partnering event for the biotech, pharmaceutical, and the contract services industry.  The show is also important to R&D professionals with an outsourcing role in discovery, CMC and clinical operations.
 
 
 

July 2011
Syntagon to exhibit at the 2011 Chem Outsourcing Show in New Jersey, USA

 

Syntagon will exhibit at the 2011 Chem Outsourcing Show on September 12th, 2011.  With over 100 speakers, the ChemOutsourcing show includes speakers, exhibitors, and attendees from the pharmaceutical and biotech industry, including a number of small molecule biotechnology company chemists. 
 
Make sure to stop by Booth #102, drop off your business card in our fish bowl for a chance to win a free iPad and chat with Syntagon to see what we have to offer.
 
 
 

June 2011
Metal impurities in drug substances

 

Currently, the International Conference on Harmonisation (ICH) Q3A guidelines classifies impurities into three main areas: organic, inorganic and residual solvents.  With a new guideline, USP outlines procedures and detection techniques for improved sensitivity and selectivity of element impurities as well as new advice on sample preparation and validation of analytical methods. 

Syntagon Case Studies
Syntagon has gained a huge amount of experience in measuring, monitoring and, if needed, reducing a wide variety of metal impurities during the course of many GMP syntheses.  By continually monitoring changes in the regulations, Syntagon ensures specifications are met and regulatory compliance is guaranteed. 

Syntagon welcomes the introduction of the new ICH Q3A guidelines, which will cover the acceptable limits of elemental impurities and the procedures by which they will be measured. 
Download Full Metal Impurities Article with Case Studies
 
 

June 2011
Syntagon to attend and sponsor BOS CMC in Copenhagen on June 16th

 

Syntagon will attend and sponsor BOS (Biotech Outsourcing Strategies) CMC in Copenhagen, Denmark on June 16th.
 
BOS CMC is the leading outsourcing partnering event for the chemistry, manufacturing and controls (CMC) industry.
 
 
 

June 2011
Syntagon to attend EPIC Biotech in London on June 15th

 

Syntagon will attend EPIC Biotech in London on June 15th. 
 
EPIC (European Partnering and Investment Conference) Biotech will host over 60 European and UK biotech presenters who are looking for partners, investments, and services.
 
 
 

June 2011
Syntagon CEO to present at Lyckad L akemedelsutveckling (Successful drug development) on June 9th

 

Michael Lofthagen, CEO of Syntagon, will present at Lyckad Lakemedelsutveckling seminar on June 9th, 2011 in Stockholm.  The conference addresses how to choose the right CRO during drug development.