As I visited the exhibits and attended the conference sessions at INTERPHEX 2013 last week, I noticed a focus on equipment flexibility and ease-of-cleaning and changeover that enables manufacturing efficiency. Read more »

The challenge of developing orally inhaled nasal drug products (OINDPs) is complicated by the interplay between drug-delivery devices and formulation. An article in the February 2013 issues of Pharmaceutical Technology and Pharmaceutical Technology Europe, “Improving Inhaled Product Testing: Methods for obtaining better in vitro-in vivo relationships,” discussed testing equipment and techniques. PharmTech recently interviewed the author, Mark Copley, sales director at Copley Scientific, to gain further insight into the importance of this topic. Read more »

Pharmaceutical Technology will be moderating a panel discussion, “Lessons Learned: Successes and Challenges in Implementing Quality by Design,” on Wednesday Apr. 24 from 10:15 to 11:15 at INTERPHEX in New York City. You can listen to a podcast about the panel discussion that is posted on PharmTech’s homepage.

Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co., will provide expertise on application of design space and control strategies for API manufacturing. Dr. Chris Moreton, FinnBrit Consulting, will share his expertise in how to incorporate excipients into the design space. Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management will use his experience to discuss challenges in adapting the manufacturing process from a control perspective. Together, the panel will consider the benefits of adapting QbD and the challenges yet to be addressed. I hope to see you there.

Pharmaceutical Technology interviewed some of the speakers for the upcoming INTERPHEX 2013 conference to get a “sneak peek” of their presentations. The first of these, an interview with Par Almhem, president of ModWave and Modular Partners, discusses advances in modularization. Check out the media player on the PharmTech website or click here to listen to the podcast, and look for more to come soon. If you’re at the show, be sure to stop by PharmTech’s booth (Booth #4139).

Representatives from Merck, Pfizer, and Novartis shared their recent efforts in applying quality-by-design (QbD) concepts to analytical methods, and Todd Cecil from USP explained the related new draft USP chapter in a symposium at Pittcon on Monday, March 18, 2013. The session, “Understanding Analytical Method Variance and the Impact for QbD Filing for Pharmaceutical Products,” was sponsored by the American Chemical Society’s Division of Analytical Chemistry (ACS ANYL) and the American Association of Pharmaceutical Scientist’s  Analysis and Pharmaceutical Quality Section (AAPS APQ). Read more »

Are equipment innovations keeping up with manufacturers’ needs? What do industry members think about quality by design and process analytical technology? The editors at Pharmaceutical Technology and Pharmaceutical Technology Europe are currently running a survey of trends in finished drug product manufacturing and innovation in pharmaceutical equipment and manufacturing to gain feedback on these and other questions. Are you involved with machinery and equipment for solid dosage or parenteral products? Click here to take the survey. Read more »

In an article called “Beyond magic bullets: true innovation in health care,” published in the February 2013 issue of Nature Reviews Drug Discovery, scientists from Janssen encouraged the healthcare industry to think outside of the drug product-focused box and look at an integrated approach to care, said a Janssen press release. Read more »

Revisions to the United States Pharmacopeia (USP) General Chapter<231>Heavy Metals have been much discussed over the past decade. USP is in the process of replacing this chapter with General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Methods, which were published in USP 35-NF 30, Second Supplement. The official date for the new chapters—originally Dec. 1, 2012—was briefly postponed due to an appeals process but was recently re-established as Feb. 1, 2013, as described in today’s PharmTech news article.
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Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October. I received one of the last doses the clinic had on hand, and two other places I called were already out. Apparently, others in the US have been experiencing similar situations. FDA Commissioner Margaret Hamburg posted Jan. 14 on the FDA blog that vaccines are available but FDA is monitoring spot shortages. Read more »

How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue. Real-time devices for continuous feeding processes, among many other topics, were discussed at a seminar I attended last week. The seminar, “Advances in Pharmaceutical Processing”, was sponsored by K-Tron, which supplies material handling and feeding systems. Read more »