i3 is a global business providing integrated scientific strategies and solutions throughout the biopharmaceutical product lifecycle. Its combination of products, services, and knowledge helps companies gain sharper insights that lead to better patient care. i3 Research i3 Research is a full-service clinical research organization (CRO) focused in cardiology, central nervous system, endocrinology and metabolic disease, oncology, and respiratory and infectious disease. Therapeutic specialization drives all aspects of this group’s business — from project staffing and talent management to quality initiatives,…
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Integration of Disposable Technology
The use of single-use components in the biopharmaceutical industry is not new. For more than a decade, a range of disposables have been available and commonly used — plastic film bioprocessing containers, microbial sampling bags, encapsulated filters, sterile connection devices, tubing, flasks, roller bottles and hollow-fiber membrane systems, to name a few. What began as a handful of individual components is now evolving into a category of preassembled, sterilized, and validated integrated disposable systems. The latest innovations to hit the…
In the Clinical Trials Zone
A new product takes a long and winding road from a laboratory to the patients it is designed to help. Many factors and organizations affect just how many months and dollars it will take to shepherd a new product from preclinical studies to market. Carefully documented, regulatory-compliant clinical trials are key to marketing approval. Clinical trials involve a choreographed network of regulatory agencies, sponsor companies, and clinical investigators. Myriad specialists in that network include those who produce and deliver an…
Taking the Next Step
Long-term hopes for stem cells to cure various diseases are nourished by the latest developments in stem cell research. First clinical studies have begun (Thera Vitae, Israel: congestive heart insufficiency), and patents have been filed (Stem Cell Therapeutics, Canada: combined regulation for the production of neural cells). Clinical use depends on technological requirements for a reproducible cultivation and controlled differentiation of cells in sufficient numbers, so more and more researchers are focusing on the scale-up of stem cell production. For…