Using an ongoing IT reorganization project at Merck as an example, Tim Rehac of BusinessEdge Solutions discussed changing the structure of an IT organization in his presentation “Implementing a Service-Oriented Organization in IT” at INTERPHEX last week. The session showed how an IT organization could be transformed into a more efficient and innovative unit. Read more »
Archive for the 'INTERPHEX 2008' Category
The pharmaceutical industry, like many business sectors, generates tons of money. Its C-level leaders thrive on competition and profit, constantly striving to get the next big drug or pushing to get into the next major market first. And for US-based pharma companies, there’s an even larger expectation to “win, win, win” in the global marketplace—to drive the “American dream,” so to speak, to its full potential. Read more »
Exhibitors packing up from this year’s Interphex show, 26-28 March, went home happy. Traffic in the aisles was steady, booth personnel were busy and the quality of the visitors was high. It seemed like a higher than usual number of packaging machinery makers were seen engaged in serious discussions with customers. So despite rising oil prices, the mortgage crisis and falling real estate values, there appears to be a fairly high level of active projects for new and upgraded lines. In addition, anticounterfeiting tools/techniques continue to draw a lot of attention along with the use of disposable product contact parts, pedigree solutions, robotics and quality control. Stay tuned for a report about the most interesting new packaging products we found on the show floor.
Posted by Michelle Hoffman for Hallie Forcinio, Packaging Forum Editor, Pharmaceutical Technology
Increased capacity, fewer errors, no more paperwork. These were some of the key points to take away from the presentation by John Helfrich of VelQuest Corporation called “CGMP Informatics: IT Infrastructure Design for 21st Century Pharmaceutical QC Operations” at INTERPHEX. Read more »
We all understand the benefits of quality by design (QbD), don’t we? Maybe not. Justin O. Neway of Aegis Analytical made me reconsider my assumption that this was true. During his presentation about achieving manufacturing-process excellence, Neway cited a survey that asked manufacturers what the biggest obstacle was to progress on their QbD programs. The most common response (given by nearly half of respondents) was that they had too many other things to do.
Come again? Read more »
Optimizing a method for detecting contaminants in a drug product is critical, and Joe Gecsey, business development manager of life sciences for Hach Ultra Analytics, discussed an approach taken for an inhaled drug product at his presentation, “Analysis of Particle Size and Distribution in a CFC-Free Aerosol Based Pharmaceutical Preparation,” at Interphex. Read more »
My conversation with a contract developer on the show floor this morning confirmed what I’d been hearing: drug companies are searching for new routes of administation for their established drugs. Though there’s been an increase in candidates in Phase I and Phase II studies, fewer candidates are making it to Phase III and commercialization than in the past. Read more »
Brian Stephens, a life sciences consultant for ABB INC, addressed the Interphex 2008 attendees this morning in a discussion about process analytical technology (PAT). He threw out the “learn, predict, control” phrase industry has latched onto as an easier way to define PAT, which is essentially a tool or system for implementing QbD that involves identifying critical quality attributes (CQAs) and critical process parameters (CPPs), and then figuring out the best way to measure the CQAs in order to control the CPPs.
Stephens went on to describe how some 60 FDA investigators are undergoing PAT training this year so they can be better prepared for inspections (and ideally avoid a repeat of the validation inspection process of the 1980s and early 1990s when computer validation came into play). (I find it quite strange, by the way, that FDA has been rolling out and pushing PAT initiatives while still learning about it themselves. Seems like the order of things here is somewhat backward.) Read more »
Readers of PharmTech may have noticed that I’ve been concerned about innovation in the pharmaceutical industry and somewhat despairing of the state of early-stage drug discovery work. So you can imagine my thrill–and relief–yesterday when I had a chance to meet the finalists for the “Facility of the Year Awards” (FOYA), sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, and learned of the truly amazing solutions that engineers are implementing to current industry problems. Among those problems, two stood out in particular: the need to get a plant built and online quickly, and the need for flexible designs in plants engineered to manufacture multiple products and–even more impressive–product classes.
In the first category, speedy, design and manufacture, engineers who designed and built Pfizer’s plant in in Illertissen, Germany, and those who managed the project for Roche’s new facility in Basel, Switzerland, completed their projects four to six months ahead of schedule and remained under budget. Pfizer’s plant is almost totally automated, and requires only two human operators per shift, earning the plant’s engineering team the award for process innovation. The Roche project was completed in record time, earning its project manager the award for project execution. Read more »