EPM Magazine - Blog

Clampdown on Counterfeit Drugs

2011-02-17T07:53:00.000-08:00

On Wednesday, the European Parliament voted by an overwhelming majority (569 in favour out of a total of 588 votes) on the new Falsified Medicines Directive.

The objective of the directive is to improve the traceability of medicines throughout the whole value chain and increase consumer safety. Click here to read the full news story on the European Parliament website. If you would like to share your opinion on this announcement, please feel free to 'comment'.

The March/April issue of EPM will feature a timely special focus on Anti-Counterfeiting and Security, so if your company is involved in these areas, please contact the editor Elizabeth Valero, on +44 (0)1829 770 037.

Gearing Up for interpack 2011

2011-02-11T07:42:00.000-08:00

The EPM team is gearing up for interpack 2011. In the next (11/2) issue of EPM magazine, there will be an interpack Preview, featuring a lowdown on exhibitors' plans for the event. There will also be 'focus on interpack' online newsletters sent in the weeks leading up to the event.

If you are an interpack exhibitor, EPM 11/2 is an issue not to be missed as will be available at the event, so please email your news (including Hall and Stand numbers, which will be bolded up), with accompanying picture or logo, to the editor Elizabeth Valero: ellie@rapidnews.com. The deadline is Friday 18th March.

If you are interested in advertising in the magazine or online, please contact either Caroline Plant, caroline@rapidnews.com, or Mike Taylor, taylorms@btinternet.com.

The entire EPM team will be attending the event, so if you would like to meet with any one of us, please call +44 (0)1829 770 037.

CPhI/ICSE — So Many Companies, So Little Time...

2010-10-18T03:12:00.000-07:00

I have just returned from a very informative and fruitful (in terms of building relations) trip to CPhI/ICSE. I had a pretty packed timetable and although I managed to get round and see plenty of companies, I still left feeling there were so many more I might have seen had there been more time, which is of course always the way with these shows.

Our main intention was obviously to make these companies (more) aware of our new, pullout section ICMS (Ingredients and Contract Manufacturing Solutions) and, from my point of view, to get some interesting content lined up for future issues. To this end, I have most certainly succeeded, as readers will glean from the next (November/December) magazine.

My first stop was the Avantor Performance Materials (formerly Mallinkrodt Baker) stand, where I met with President Ron Harding and Global Marketing Director Herman Mitchell.

The company announced its new name — following its acquisition by an affiliate of New Mountain Capital in August — just days prior to CPhI, and was highlighting its PanExcea range of performance excipients. Ron explained: “The PanExcea range boasts exceptional flowability characteristics and porosity for bonding directly with APIs, so it’s a real breakthough.

However, Herman was keen to point out that “Avantor doesn’t just supply excipients, but also works with companies on their formulations.”

Ron added: Another key selling point for us is supply chain management; we can guarantee total, end-to-end security of a product.

Ron concluded that there were plenty of announcements in the pipeline for next year and ICMS would be at the top of Avantor’s list for receiving these.

I met Hovione’s Global Sales Director Roger Viney, who incidentally will be the interviewee for our Q&A in the next edition. Hovione — a specialist in process chemistry development, manufacture and custom synthesis of APIs — was in fact responsible for the article in our CPhI issue entitled ‘Bridging the Gap Between HAPI Production and Material Science’, which reveals how the company has adapted and what it considers are the key criteria to ensuring safe and efficient large-scale manufacturing of potent compounds (this can be downloaded from our homepage).

Impressed with how everything had gone with regards to the show thus far, Roger said: “It’s only the first day and we’ve already had a number of enquiries.”

As well as its API capabilities, the company was promoting its TwinCaps dry powder inhaler, which was granted approval for the treatment of influenza in Japan only the week prior to CPhI. “It’s another very valuable string to our bow,” added Roger.

The approval has been granted to Daiichi Sankyo Company Ltd, a licensee of Hovione, for Inavir (TwinCaps) — a 20 mg dry powder inhaler that delivers the drug directly to the infected airways of influenza patients.

According to Roger, the low cost of the device means it can be disposable and is therefore ideally suited for the treatment of lung infection.

I had a very interesting conversation with Patheon’s CEO Wes Wheeler. The company’s stand was very busy, as was the man himself (so much so that I had to return at a later time). Wes stressed that although Patheon does not produce APIs, it has a real stronghold in the development, scale-up and commercial manufacture of pharmaceuticals, with a total of 15 sites — including “cutting edge sterile and lyophilisation facilities” — dedicated to this. “We are the number 2 contract manufacturer in the world,” he said. Add to this the fact that they are “the only publically trading company” and you cannot fail to be impressed. ICMS receives and often publishes quarterly fiscal results from Patheon, which according to Wes sets Patheon apart from its competition, as only publically trading companies are allowed to do this.

Wes went on to talk about a very topical subject for the contract manufacturing industry — the FDA and EMEA’s stepping up inspection and enforcements (formerly known as compliance) in coming years. He said: “Contract manufacturers will be forced to stay ahead of the game; they will have to either start investing or consolidating. I can see a lot of our competitors disappearing over the next few years, but Patheon is more than capable of weathering the storm, as we continually invest in the latest technologies to ensure that we remain at the forefront of the contract manufacturing market."

Wes has kindly agreed to write an Opinion piece on this very controversial topic for our Jan/Feb issue.

I also caught up with CARBOGEN AMCIS’ Commercial Director Rhona McIntyre, who was the Executive Q&A interviewee in our CPhI issue. CARBOGEN AMCIS — a provider of services for all stages of drug development and commercialisation — has had, according to Rhona, an exceptional year.

Rhona referred specifically to CARBOGEN AMCIS’ successful collaborations with Airjen and Next Pharma to provide pre-formulation services, but was also keen to point out that the company had, during the course of the year, introduced some of these services inhouse; one such service being pre-form polymorph solid state analysis, which offers companies an insight into powder flow characteristics etc.

“The collaborations with Airjen and Next Pharma have enabled us to provide companies with a full data package to take straight to production, however we are constantly expanding and are working towards being able to offer more of these services internally,” she said.

My final mention (and so I can finish on a somewhat lighthearted note) goes to SCM Pharma, mainly because of the amount of creativity that had gone into the sterile fill/finish company’s stand (pictured). Two members of staff, dressed as cartoon-style characters Radioactive Ray and Potent Pete, were used to draw the crowds and, according to Commercial Marketing Manager Raman Seghal, they did just that. “We’re very pleased with how the show has gone; we’re returning with a number of leads and hopefully several new projects in the pipeline,” he said. “I think this fun, cartoon super-heroes theme has played a huge part in attracting visitors to our stand.”

The stand also boasted an isolation booth containing sweets and a freezer, with ‘WARNING — Pushing Button May Release Nostalgic Frozen Freebies’ stamped across it, containing ice pops, not unlike a scene out of Charlie and The Chocolate Factory.

It would be impossible to mention all companies/everyone I spoke to and their news, but please visit the EPM website and have a read of the next ICMS for further updates.

Countdown to CPhI Worldwide/ICSE Europe

2010-07-28T02:38:00.000-07:00

CPhI Worldwide/ICSE Europe is fast approaching and we — the editorial and sales teams at EPM — are gearing up for this all-important event. Hopefully, you will by now have seen the new, pullout section ICMS (Ingredients and Contract Manufacturing Solutions). As the name suggests, ICMS contains up-to-date announcements from suppliers of pharmaceutical ingredients and contract services relating to drug development and manufacturing, as well as a wide range of comprehensive case studies and articles.

In the next edition of ICMS (appearing in the September issue of EPM), there will be a CPhI/ICSE Preview, with descriptions of and announcements by companies exhibiting at the event; providing a quick and easy reference guide. You will be able to pick up a copy of the September issue at the show.

Also, in the run-up to CPhI/iCSE, we will be sending out CPhI/iCSE newsletters, so if you are not already registered to receive these, please click here http://www.epmmagazine.com/x/subscriberNew.html.

Both the editorial and sales teams will be attending the event, so if you are an exhibitor and would like us to drop by your stand to discuss the submission of editorial content or advertising opportunities, please get in touch — by tel: +44 (0) 1829 770 037 or email: ellie@rapidnews.com.

We look forward to seeing you there!

Elizabeth, Editor of EPM/ICMS

New Order

2009-06-09T07:41:00.000-07:00

The last few days in this little corner of the world have been filled with sun, and people's moods seem to have improved significantly. There is a noticeable change in attitudes and an almost palpable optimism is taking the place of the recent winter stagnation.

And is it just me, or has this weather got an impact on our views on recession? The beaming sun seems to have altered people's mind-sets and we believe, or try to believe, that soon the financial crisis will be over and we will all be able to carry on living the way we did before the economic meltdown.

But is it ever going to be the same? Perhaps this is the time to re-evaluate the state of the global economy for good and come to terms with the fact that the world is changing around us.

Not long ago, two-thirds of the world's pharmaceutical markets were located in Europe and North America, with a great minority of the world's population responsible for the vast majority of manufacture and use of pharmaceutical products.

In the new reality, the proportions will have to be changed for a few main reasons. Growth in the main pharmaceutical hubs, such as North America, is expected to slow down significantly due to expiring patents and generic drugs gaining popularity.

Furthermore, growing consumer trends in the new and emerging markets have also got a bearing on the sales of medicines. It is Central and Eastern Europe, and not the established Western-European markets, that are expected to help the pharma industry come out of the recession.

Over the next five years, countries such as Russia, Brazil, India, China, Turkey or Mexico are expected to drive 40-50% of global market growth, compared to just 10% in 2003. Middle Eastern countries are also among those gaining strength on the back of the established markets' slowdown.

All this has to be taken into consideration when planning the business strategy for the coming years. Changes are often daunting, but certainly necessary, and with an adequate dose of optimism and willingness to adjust, the pharma industry will be able to find its way out of the current downturn.

Life after ACHEMA

2009-06-09T07:39:00.000-07:00

And so life after ACHEMA begins. This year was my first time at the show and I was very glad to be able to meet so many of you there. The show was everything I expected it to be and more, with queues to get into some of the halls and thousands of visitors admiring the stands of both the industry giants and small family-run companies.

All the exhibitors I spoke to were extremely satisfied with the number of visitors to their booths and the interest shown. In the difficult economic environment of today, ACHEMA seemed almost completely unaffected. Even though the tough market conditions were talked about a lot at the stands, the exhibitors seem to have done the only right thing, and showed themselves from their best side. Our readers can find some post-show news from some of the exhibitors in the ACHEMA Review in EPM 9/3.

Please remember that you can now find all the news, and more, on our regularly-updated website, pharm-europe.com, and our very popular Twitter stream, EPM_Magazine. Have a look at them while resting your sore feet and reminiscing after this year's very successful ACHEMA.

Visit to Pfaudler-Balfour in Scotland

2009-03-03T08:06:00.000-08:00

Just over a week ago I had the pleasure of visiting the manufacturing facility of Pfaudler-Balfour in Leven, Scotland. Pfaudler, a part of the Robbins Myers Process Solutions Group, is best known for providing innovative products made of glassed steel used to optimise fluid processes in the chemical and pharmaceutical industry.

In fact, together with other Process Solutions Group companies, including Chemineer, Edlon, GPS, CRS and Tycon Technoglass, the company now provides a one-stop-shop for the chemical process, pharmaceutical, power, biotech and many other industries.

Within this diversified group, each of the companies has its own precise role, and so: Pfaudler focuses on producing, among others: advanced reactors and storage vessels, innovative instrumentation, mixing systems, heat exchangers and glass-lined pipes; Tycon Technologies specialises in glass-lined vessels and equipment for chemical and pharmaceutical processing; Chemineer mainly deals with research, design and manufacturing of high-quality, high-volume mixing solutions, and Edlon is a leading manufacturer of process solutions based on engineered polymers, including: coatings, linings, glass-lined vessel accessories and column systems. GPS and CRS provide high-quality replacement parts and field service for all the Process Solutions Group Products.

I was truly impressed by the Pfaudler-Balfour facility to which I was invited. It is located in Leven, in the Kingdom of Fife, Scotland, and next year it is going to be celebrating its 200-year anniversary.

A forty-five-minute drive from Edinburgh airport and I was already sitting at the Pfaudler-Balfour conference room, enjoying coffee and biscuits, and the interesting presentation from the Group Products Sales Manager, Neil Davies, and Edlon Product Manager, Douglas Low, with Kerry Clunie, Process Manager, and Chris French from POD PR.

The presentation included a short description of the products and services offered by each of the sister companies, and then I had a chance to see for myself what exactly goes on in the manufacturing facility. I was taken on a little tour by Neil Davies, who explained in detail the technique of lining the huge steel vessels with glass. The reactor vessels would have impressed anybody: the largest I was able to see had about 100 m3 capacity, and yet they can go up to unimaginable 130 m3, which reportedly is the biggest in the world.

I got to see vessels in every stage of production, which is a long process involving heating them up to around 850ºC (until they actually glow), controlled cooling, and being sprayed numerous coats of glass lining. As I was told, every piece of Pfaudler glass-lined equipment features the Glasteel technology, which is the global standard for the industry.

I also managed to see the Edlon part of the business, which produces the so-called ‘plastic steel’, based on fluoropolymers, which is used for applications where there’s a possibility of chemistry between the lined product and glass.

Pfaudler-Balfour is able to offer used equipment, which is completely serviced, re-glassed, with seals replaced. I don’t have to tell you about the obvious advantages this presents, saving clients time and money, still with full warranty from the original manufacturer.

The day up in Scotland was incredibly interesting, and I was very impressed with the size of the facility, its organisation, and the professionalism of the staff. Indeed, it seemed a lot cleaner and more organised than I could ever imagine a facility of that size to be. I got a chance to look into a huge reactor vessel and inside a magnificent furnace, and that certainly isn’t something that happens every day!

Welcome to the EPM Blog!

2009-02-24T02:49:00.001-08:00

In this ninth year of European Pharmaceutical Manufacturer magazine there have already been a lot of changes to the way we do things.

If you have been reading EPM from the beginning, you probably have noticed how the major technological breakthroughs in communication have affected us. Some of the editors who have been with the company for a long time can still remember the times when all press releases were sent to us in print... Not to mention the first dial-up modems with their characteristic buzzing noise...

But things have moved on and nowadays, apart from the obvious, such as the website updated every day with the fresh press releases straight from the pharmaceutical suppliers, EPM is exploring and making use of many other communication channels.

And so, you can now find us on Twitter (look for EPM_Magazine), Facebook and Linked-In, we have our own YouTube page with interesting videos submitted by the major pharma industry suppliers, and of course this blog, which will give a great insight into what currently goes on at the EPM headquarters, which trade shows we're visiting and what news we're reading and getting excited about at the moment.

Each of those channels enables us to communicate news quickly, making sure that it reaches as large a public as possible. They also allow our readers to communicate among each other, the opportunity that many of you have welcomed with open arms.

So whether you're looking for a new supplier, service, want to compare the pharma market, or save energy and, of course, money, don't miss these opportunities to find as much as you can about the current state of industry by following the EPM Blog, Twitter, and joining the EPM community on Facebook and Linked-In.

I will certainly be looking forward to seeing you there!

Aleksandra Wisniewska, Editor