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Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.
A new law that was widely described as strengthening Food and Drug Administration powers over approved drugs contains a spotlight on packaging that, among other things, will soon require unique numbering of individual packages of prescription drug products. In the FDA Amendments Act of 2007, little-noticed section 913 adds a new section to the law called "Pharmaceutical Security" that calls for federal government officials to "develop standards and validate effective technologies" to secure the drug supply chain against "counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs."
Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005. So says a report from management consultancy A.T. Kearney (www.atkearney.com), "Make Your Move: Taking Clinical Trials to the Best Location." The report cites China as the best bet for outsourcing clinical trials. According to an article posted on DrugResearcher.com http://www.drugresearcher.com/news/ng.asp?id=72702, China was chosen both for cheap labor and facilities, as well as a huge urban patient pool.
In the past 10 years, "skyrocketing costs of R&D have led to a growth explosion in the clinical services industry as pharma companies scramble to cut costs." So said Outsourcing-Pharma.com in its February 28 report, "Clinical trials in India just got cheaper."
Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005. So says a report from management consultancy A.T. Kearney, “Make Your Move: Taking Clinical Trials to the Best Location.” The report cites China as the best bet for outsourcing clinical trials.
Bioabsorbable stents, such as Abbott's Absorb, may soon open a new pathway in the treatment of coronary artery disease, and challenge the packaging process. In late October, Abbott Park, IL-based Abbott Laboratories delivered encouraging news regarding the initial results of a clinical trial involving its Absorb bioabsorbable drug-eluting stent for the treatment of coronary artery disease.
Electronic compliance monitoring packaging has been around for years, yet many pharmaceutical companies are unable to quantify the return on investment of smart packaging. Pundits who predict the future of packaging often talk bout the rise of smart packaging. What exactly is a smart package? One U.K. Web site cites examples such as time-temperature food quality labels, self-heating or self-cooling containers—any package enhanced to deliver additional consumer convenience.
I recently paid a visit to a representative of a supplier of healthcare packaging materials who showed me sophisticated "Smart" packages--this particular application was for clinical trials.
A macrolide azithromycin chronic obstructive pulmonary disease (COPD) Phase III study is using Med-ic RFID smart sensors embedded in blister packs. Sponsored by the National Institute of Health, the multiyear, double-blind study will enroll more than 1,100 patients at 10 clinical centers across the country.
When Specials Clinical Manufacturing opened its facility in Northumberland, United Kingdom, it needed a validated label printing system to manage recordkeeping and print labels for clinical trial packs.
“Initially, there was no suitable system in place for printing labels, especially labels for randomized studies and projects,” says Elaine Mackie, packaging manager at Specials, a custom drug maker and provider of packaging services for clinical trials. In need of a system that would meet GMPs and 21 CFR Part 11 regulations, Specials installed PrisymID Inc.’sMedica software with ClinTrial, an add-on module for clinical trial label printing management.
On August 2 in Boston, a DuPont Medical Packaging seminar updated information on sterilization, testing packages and materials, package printing, ISO 11607, and brand security. The last chance to participate in one of the seminars this year is Oct. 6 in Freemont, CA. Call 1-800-44-TYVEK.
RFID technology can provide some specific benefits for clinical trial packaging, but there's a downside as well. Both were spelled out by Charles Gettis, senior VP, operations, AccuLogix, at a presentation at the recent ISPE conference in October 2004.
Benefits:
• Positive identification for dispensing the right medications to the right patient, reducing dispensing errors
• Works with validated systems
• Scans supplies as they come in
• Reduces quality assurance staff tasks with 100% accuracy
• Identifies errors before a packaging run starts
• Good for injectable units
