By John Briggs, ASQ, CQA, Quality Assurance Manager - ASI
During the past six years, single-use systems and devices have emerged as key agents in the biopharmaceutical landscape. Single-use solutions have revolutionized the pharmaceutical and biopharmaceutical industry due to their effectiveness in reducing the risks of contamination and allowing faster changeovers. These advantages, coupled with the significantly reduced time and costs required to establish a new manufacturing facility, have made single-use systems the products of the future.
By Emilie Gautriaud, Keith T. Stafford, Jennifer Adamchuk, Mark W. Simon, and Duan Li Ou, Saint-Gobain, Northboro R&D Center
Silicone rubber is widely used in the pharmaceutical industry where sterilizability is an essential requirement for all fluid transfer equipment. Pharmaceutical products must be sterilized frequently and repeatedly by high-level energy and/or chemical vapor in order to eliminate bacterial surface contamination.
By Michelle Amaral, Ph.D., Science Writer, Soluble Therapeutics
Proteins perform an array of functions in living organisms: from structural scaffolds and signaling molecules to catalysts and cell-surface receptors. Structural perturbations and aberrant protein production are associated with many disease states, making these macromolecules potential candidates for pharmaceuticals. This strategy became a reality following the advent of recombinant DNA technologies, which allowed proteins to be produced on a large scale. Issues related to protein solubility can limit this approach, however, and drastically reduce the number of possible therapeutics that can be delivered to patients. “Solutions” to this problem are highly desirable.
By Ruth Olmer, Ph.D.; Sebastian Selzer; and Robert Zweigerdt, Ph.D.
Human pluripotent stem cells (hPSCs) and their derivatives have gained increased importance for industrial applications in recent years. They have a great potential for therapeutic applications as well. In vitro assays and novel regenerative therapies will require large cell quantities produced under defined conditions.
By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
Multivariate statistical process monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment.
By Dave Bode, VP, Health Care Solutions – DSC Logistics
Innovation defines a wide range of initiatives that supply chain leaders in life sciences companies are pursuing to best help their organizations meet the fundamental changes occurring in the industry: heightened regulatory enforcement, outcomes-based reimbursement, consumer vs. provider centric care, increased access to care, and new taxes. The magnitude of these changes was made perfectly clear at a healthcare conference hosted by Gartner in November, 2012.