By Wayne Koberstein, Executive Editor
Do you have a good mental picture of the life sciences supply chain? Such a common term, widely repeated without reservation — no wonder few people stop and think before they say it. A universal principle may apply: the more used, the less understood the term.
Liquid formulations pose several problems in terms of stability, handling, ease of use, etc. Solid dosage forms (tablets and capsules) are the most preferred formulations, as they offer the benefits of stability and robustness to the dosage form, as well as ease of administration, production, and packaging.
By Benjamin Frey, Senior Director, Compliance, ProPharma Group
The expectations of manufacturers and sponsors to control activities and materials provided by their suppliers has been magnified due to FDA-regulated products and the rapid expansion of globalization of the supply chain. With increased responsibilities, each organization needs to ensure that their suppliers provide services and materials that are fit for purpose through a Supplier Quality Management Lifecycle Model. The following includes recommended steps for developing and managing a supplier management program.
By James Drinkwater, Bioquell UK Process And Compliance Director
This paper reviews some of the current operational practices that incorporate sterility testing and provides an insight into the role of hydrogen peroxide vapor biodecontamination and continuous particle monitoring.
By John Yacoub, Mettler-Toledo Safeline
Considering TCO helps to better understand the costs over and above the purchase price and also — when suppliers have differing offers — to compare them and ultimately to substantiate the investment decision.
By Dave Cousins, Bosch Packaging Technology
Remaining competitive in pharmaceutical development and production can be a challenge as products become more complex to get through clinical trials and eventually production. To remain competitive, pharmaceutical companies need to develop products faster and more cost-effectively.
By Jason Frye for Flow Sciences, Inc.
We sat down to discuss nanotechnology, nanomaterials, and safety issues within this upstart industry with Donna Heidel, CIH, the prevention through design coordinator for the CDC/NIOSH (Centers for Disease Control/National Institute for Occupational Safety and Health) Education and Information Division; and Charles Geraci, Jr., Ph.D., CIH, the coordinator of the CDC’s Nanotechnology Research Center.
ChemOutsourcing is the largest USA-based API show, attracting annually 700 to 800 chemists from the pharmaceutical, biotech, and chemical industries. The show focuses on API development spanning early drug discovery through chemical development and commercial supply. Attendees are from pharmaceutical companies and suppliers of these services, including more than 100 exhibitors. The show is further distinguished by its accessible buyers and upscale seaside venue. Learn more.