News from Syntagon - 2009
Anavex Life Sciences Sees Phase I Alzheimer's Success
Switzerland-based Anavex Life Sciences Corp recently publicized information on the successful manufacture of lead compound ANAVEX 2-73 for Phase I clinical trials by Syntagon.
"ANAVEX 2-73 shows the potential to alter the course of Alzheimer's disease by using sigma receptors to correct dysfunction in the mitochondria and ultimately protect cells from oxidative success, which is believed to be an underlying cause of the disease," says Dr. Herve de Kergrohen, Anavex CEO. "We are delighted with the quality, speed and responsiveness of Syntagon in manufacturing ANAVEX 2-73 for our clinical trials," adds Kergrohen.
OxyPharma Completes Rheumatoid Arthritis Phase II Study
Swedish drug development company, OxyPharma, recently completed a Phase II study on their candidate drug Rabeximod for treatment of Rheumatoid Arthritis. Syntagon, who manufactured the clinical API and provided the entire CMC package for the Phase I and Phase II trial, would like to extend its congratulations to all at OxyPharma.
"We are very excited to conclude these trials and are very much looking forward to reviewing the results of this study," says Ulf Björklund, OxyPharma CEO. "Rabeximod is a new compound with a different mode of action with the potential to further improve the outcome for people with Rheumatoid Arthritis. We look forward to continuing our successful collaboration with Syntagon in the future," Björklund adds.
Solid-state Development: Recommendations for Phase I
In the latest of our series of White Papers, we look at how solid-form screening and development impact pharmaceutical properties such as bioavailability, stability and processability as well as physicochemical properties including physical and chemical stability, solubility, dissolution rate, hygroscopicity, crystal form and mechanical property. Syntagon shares five reflections for improving solid-state programs when moving from pre-clinical to clinical development:
- Changing your salt will change your drug.
- Development of a new solid-state form will have a strong impact on intellectual property rights.
- Divide your polymorph study into two parts: A preliminary screen for Phase I, and a detailed study for Phase II/III.
- Understanding the unique features of a specific API requires a high level of expertise.
- If your API doesn't crystallize and/or no proper salt is found, alternative solid-state techniques are available.
See full article
From building compounds to building client relationships
Project Manager, Annette Nygren, tells us why she exchanged her laboratory for the office.
Hailing from Kristinestad in Finland, and having completed an MSc at the University of Åbo Akademi, Annette joined Syntagon as an organic chemist in 2001 and is currently on our project management team.
"I'm responsible for ensuring that our projects are delivered to our clients on time and on budget," explains Annette. "Much of my work involves liaising with Syntagon's organic and analytical chemists, and providing regular progress updates and status reports to customers. When I joined the project management team, I had worked as an organic chemist for three years. The experience I gained in this role provides me with insight and understanding I find valuable in my current position. I like the open communication we have with our customers. At Syntagon we focus on getting to know our customers well, and this helps develop good relationships, which in turn makes communication easier."
How do you most effectively ensure a project remains on time and on budget?
"I think the best way of reaching project milestones is by giving clear responsibility to each team member. Three years ago we started our work with an internal visual planning system based on lean manufacturing. This, in combination with weekly internal meetings, allows us to get a good snapshot of how a project is progressing and to rapidly highlight areas that require attention, like critical decisions or resources."
What made you leave the lab and become a project manager?
"After three years in the lab I was ready for a new challenge. An opportunity arose to join the project management team an I jumped at it. I haven't looked back since."
Do you have any hidden talents?
"Well, I enjoy making clothes when I have time."
What sort of clothes do you make? Glitzy evening wear, or is it perhaps refinements to practical lab clothing?
"Ha ha! Not lab clothing anyway. Mainly for children and myself."
Do you have a golden chemistry moment that you could tell us about?
"It would have to be in 2001 when I was performing my first crystallization on 50L scale. Coming from an academic background, I was amazed to see how the crystals formed in the reactor, and fascinated to see kilogram amounts of crystals on the filter paper instead of mg amounts I'd seen previously."
And in other news from Sweden...
On Wednesday, The Royal Swedish Academy of Sciences awarded the Nobel Prize in Chemistry for 2009 jointly to Venkatraman Ramakrishnan (MRC Laboratory of Molecular Biology, Cambridge, U.K.), Thomas A. Steitz (Yale University, New Haven, CT, USA) and Ada E. Yonath (Weizmann Institute of Science, Rehovot, Israel).
The Nobel Prize in Chemistry for 2009 awards studies of one of life's core processes: the ribosome's involvement in the translation of DNA into proteins. Ribosomes produce proteins, which in turn control the chemistry in all living organisms. As ribosomes are crucial to life, they are also a major target for new antibiotics. This year's Laureates showed what the ribosome looks like and how it functions at the atomic level. All three used X-ray crystallography to map the position for every atom that makes up the ribosome. These 3D models show how different atibiotics bind to the ribosome. These models are now used by scientists to develop new antibiotics, directly assisting in saving lives and reducing human suffering.
Syntagon celebrates 10th anniversary
Just ten years ago, Syntagon started out in a converted warehouse with three employees, some modest HPLC and GC equipment and a 20-liter reactor. Initially, we focused on medicinal chemistry customers across the Stockholm region. As our customer base grew, so did our team, service offerings and investment in new equipment, instrumentation and facilities.
Today, Syntagon employs over 40 specialists in Sweden and Latvia, and has recently expanded its raw material sourcing operations with new premises in Shanghai. We routinely help more than 150 biotechnology and pharmaceutical customers to develop their compounds from lead optimization to Phase II clinical trials. We're proud to have evolved into a leading drug development partner in both Europe and the United States.
We would like to take this opportunity to thank each of our partners and customers for their support during the past decade, and we look forward to serving and growing with you over the coming years.
Syntagon launches Shanghai sourcing operations
In the coming months, Syntagon will expand its global presence by opening new premises in Shanghai. The expansion is set to further improve our raw material sourcing capabilities - often a considerable cost element in clinical API production.
"Our Shanghai office will allow us to source high quality raw materials at competitive rates. Savings we will then be able to pass on to our clients," says CEO Michael Lofthagen.
The acquisition of raw materials tends to represent a significant part of the overall costs of conducting clinical trials. Our Shanghai offices will have access to a broader choice of suppliers, and an immediate contact that will allow Syntagon to deliver materials more rapidly at more attractive prices.
"By having a presence on the ground in Shanghai, we have direct access to many raw material suppliers, thereby avoiding agents and middlemen, and reduce delivery time," explains Lofthagen.
The Shanghai offices will complement our existing operations in Södertälje, Sweden, and Riga, Latvia.
A pragmatic approach to controlling potential genotoxic impurities for Phase I
Qualifying and controlling impurities is a key activity during the development of new drugs. ICH Q3A and Q3B provide the appropriate guidance for the drug developers as to what needs to be met at the finish line, when the product is ready for the market. One very important consideration given in these guidance documents is that impurities at levels below 0.05% "fly below the radar cover" and are not considered unless they are of special concern.
Syntagon to supply clinical material for Nobel Prize Laureate
Syntagon and A. Carlsson Research AB have entered into an agreement in which Syntagon will develop the lead compound, OSU 6162, for Phase I clinical trials. Arvid Carlsson, CEO of A. Carlsson Research, won the Nobel Prize in Physiology or Medicine in 2000 for his discovery of dopamine's function as a neurotransmitter. His research has led to the realization that Parkinson's disease is cause by a lack of dopamine in certain parts of the brain.
In the first set of clinical trials, A. Carlsson Research will explore the effects of OSU 6162 on Parkinson's disease, Huntington's disease and Brain Fatigue. When asked how the partnership came about, Arvid Carlsson explains: "We had heard good reports about Syntagon within the Swedish community. They are technically excellent, fast-responding and an ideal partner for a company of our size."
Historically low exchange rates cut costs for customers abroad
In recent months, the weakening of the Swedish krona (SEK) has substantially reduced the cost of Swedish exports. The euro has reached record highs against the krona in March alone, while exchange rates for currencies such as the US dollar and Swiss franc have strengthened by 46% and 32%, respectively, in the course of just one year.
For Syntagon's customers abroad this means that the cost of developing or analyzing your compound has been significantly lowered. To take full advantage of these favorable exchange rates, contact Syntagon for a quotation today.
CHART: USD to SEK exchange rate trends, March 2008 to March 2009 (value: 1,000 USD)
Tips and tools from Syntagon
How to eliminate risks on the road to Phase I clinical trials
When it comes to developing a new API, why take unnecessary risks? Syntagon has identified five critical issues that are often overlooked when developing material for Phase I clinical trials:
Improve solubility, stability and bioavailability: establish solid-state form for your compound at an early stage
Take control and track changes: plan ahead for purity profile, safety and toxicological studies
Maintain a consistent analytical method for purity and assay
Carefully consider an appropriate level of quality and scale: define specifications to avoid backtracking
Allow ample time for critical activities
See full article
Syntagon launches new website
On the 27th of February, Syntagon’s new website was launched to reflect its continued customer focus and its growing reputation as the best drug development partner to the biotechnology and pharmaceutical industries. With the help of new corporate branding, the website provides a fresh look combined with easy-to-find company and service information as well as a wealth of current industry information. As Syntagon’s Director of Sales & Marketing, John Cameron, explains: “We wanted the web site to be more closely aligned to our strategic strengths – providing the right ingredients for a successful start to clinical trials – as well as being easily informative to our customers.”
Meet us at Biotrinity 2009
Oxford, UK: April 2-3
Are you thinking about attending the UK’s premier Biotechnology and Investment Conference? Then why not arrange a meeting with us to find out how Syntagon can help you get your compound into clinical trials? Request a meeting directly with Syntagon at firstname.lastname@example.org or register with Biotrinity at www.biotrinity.com
Syntagon is a proud sponsor of UNICEF
Syntagon is proud to announce that it has entered into a sponsorship agreement with UNICEF’s child health programme. The donation made by Syntagon will provide polio vaccinations for over 1,300 African children.