Just over a week ago, I decided to hop on the early train to Glasgow, Scotland, so that I might catch at least half of the 8th bioProcess UK conference, focusing on advancing next generation therapies. The meeting was held in the very fitting Glasgow Science Center and, given the strikes over public sector pensions that day, there were plenty of youngsters mingling with the crowds—the next generation of bioprocess engineers perhaps? Amazingly, presentations were delivered in the IMAX theatre—I have never seen PowerPoint slides on such a scale before—but given the eminence of some of the keynote speakers involved, it too was quite apt. Read more »
On November 20–21, I had the honour of being Chairman at the Sterile Manufacturing Dialogue in Old Windsor, England. Despite a very foggy Sunday night and concern that European speakers and delegates would be delayed (many were forced to land at Gatwick airport rather than Heathrow), a healthy turn out early on Monday morning proved the worries to be unfounded.
After I kick-started the conference with a few choice words, notably the idea that many of those present would be unlikely to let me into their kitchens, let alone their sterile manufacturing facilities, the main event began. Read more »
Come early next week I will be fully ensconced in deep discussions over cleanroom environments, microbial monitoring and single-use technologies in the beautiful setting of Old Windsor in England. I may also possibly take afternoon tea with the Queen in her castle, if discussions finish early. Read more »
Another very busy day at CPhI Worldwide and co-located events with good meetings in every corner for all exhibitors.
If you missed yesterday’s blog, the winner of the Innovation Awards was Glycotope for its GlycoExpress platform technology, which optimised glycosylation of antibodies and other biotherapeutics. The award was received by a very proud and happy Jens Pohl, managing director on Oct. 25, 2011. Read more »
Walking through the halls of CPhI Worldwide, it was hard to recognise it as the space just a few short hours before; the place had been transformed by teams, presumably working through the night, and the addition of a good many people provided enough hustle and bustle even early on to indicate that it would be a good show for all. Read more »
The day started with a 5 o’clock alarm call and me feeling remarkably fresh to begin my journey to Frankfurt for this year’s CPhI Worldwide event. Unfortunately, the idea of a smooth journey was thwarted fairly quickly with the news at Crewe that the 06:33 train to Manchester airport was canceled. Bad start. Read more »
Partnerships and strategic agreements are common in the pharma industry. Flicking through my inbox of the last few days I see Bristol-Myers Squibb and Ono, Catalent and Toyobo Biologics… both very sensible. But one particular announcement this week gave me cause to raise my eyebrows and smile.
The online sale of pharmaceutical products is a big headache for regulators. The Internet is the counterfeiter’s dream market stall, and virtually begs to be abused. Some surveys suggest that more than 60% of drugs purchased online are fake. But governments and regulators are fighting back. In July, the EMA welcomed a new directive on falsified medicines that had a strong focus on the sale of illegal medicinal products on the Internet—somewhat obscurely referred to as “sale at a distance to the public”—and the European Commission was charged with creating a cryptographic logo to identify legal sites.
Botox is a household name when it comes to vanity and related calls for cosmetic surgery. Produced by bacteria (Clostridium botulinum), botulinum is a powerful neurotoxin—it seems strange to me that people have overcome such dangerous sounding words to repeatedly request that it be injected in their face. But then again, fans of tattoos and piercings are not phased by thick needles, pain (or disfigurement), and (off-topic but interesting) a British student recently had her tongue surgically lengthened to help improve her Korean pronunciation. We’re ok with body modification then. And why not? Read more »
In my first blog post on the 4th PDA Europe Workshop on Monoclonal Antibodies, I touched upon some of the issues discussed around the QbD paradigm, the assessment of critical quality attributes and what this actually means to industry and regulators alike. There was plenty of discussion and debate, with one or two people questioning whether a QbD approach was even practicable. Read more »