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A cloud of uncertainty hangs over the pharmaceutical industry in Puerto Rico following the expiration of tax incentives from Section 936 of the U.S. Internal Revenue Code. Could emerging combinations of biopharmaceuticals and medical devices provide a silver lining? A report from Interphex Puerto Rico.
Synchronized lines, rather than individual pieces of equipment, will be a focus of pharmaceutical manufacturers, predicts PMMI’s Ben Miyares. In this exclusive Q&A interview with Healthcare Packaging, Miyares addresses multiple healthcare packaging-related issues, including mechatronics and robotics, which, he says, "have the potential to transform the development of packaging equipment." He also looks at sustainability, packaging equipment purchase considerations, E-machinery, and counterfeiting topics.
Are restricted access barrier systems (RABS) and isolators replacing traditional cleanrooms? All have the same aseptic requirements, but some argue that isolators and RABS increase asepsis. Many companies, especially large pharmaceuticals, are making the switch from cleanrooms to RABS or isolators. But others remain leery of these relatively new technologies. The first isolators of the early 90s fell short of expectations, leading to the development of RABS as an alternative.
Arguably, one of the most promising areas in the healthcare sector is biologics. Biologics-based products and combination products appeal to some pharmaceutical firms not just for their treatment potential, but for their financial prospects, and for their ability to extend patent protection. “There is a lot more patent protection around these [biologics] molecules,” says Robert Smith, a director at Genzyme in the U.K. “Proteins and biologics are larger molecules than typical drugs."
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.
"With the rapid growth in the biopharmaceutical industry over the past two decades, the number of newly approved biological products has dramatically increased," says the Intl. Society for Pharmaceutical Engineering (ISPE). "In 2005, a record 21 biological products received U.S. Food and Drug Administration approvals, including therapies for the treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders."
“With the rapid growth in the biopharmaceutical industry over the past two decades, the number of newly approved biological products has dramatically increased. In 2005, a record 21 biological products received U.S. Food and Drug Administration approvals, including therapies for the treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders,” says the Intl. Society for Pharmaceutical Engineering (ISPE). With that in mind, the organization has released the ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products .
