Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the sixth in a six-part series on how single-use systems (SUS) are changing the modern biotechnology facility design and construction paradigm.
Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.
In 1931, Swiss doctor Paul Niehans injected a preparation of live cells from a parathyroid gland into a dying patient. The patient subsequently recovered, and Dr. Niehans had a eureka moment — that injections of living cells can have tremendous therapeutic value.
Frost & Sullivan recently invited academic and industry leaders in neuroscience research to participate in a unique thought leadership forum, our Virtual Think Tank series, titled Biomarkers for the Brain. This forum brought together leading minds involved in the study of biomarkers of central nervous system (CNS) diseases and disorders. The Virtual Think Tank stirred discussion about technological advancements in the field, current progress, future implications of the research and development occurring today, plus unmet needs in tools, key challenges that still remain, and expectations for future usage of biomarkers in CNS diseases.
Industry experts joined a panel at Frost & Sullivan's Virtual Think Tank recently to discuss the current state of immunotherapies, implications of research and development occurring today, key challenges, and future approaches to the targeted use of the immune system in cancer treatment. Read their thoughts on immunotherapies and the critical role for the immune system to play, especially in the advanced stages of cancer, since traditional standard-of-care therapies do often work fairly well.
Read these tips to help maximize cell separation and isolation and set you up for downstream processes, including cell sorting.
Helpful tips such as carefully choosing the most suitable fixative and permeabilization reagents as well as other factors that should be considered when designing intracellular flow experiments.
Pharmaceutical plants cannot be treated like real estate. Instead, they require a detailed assessment of where they are in “operational compliance and production readiness.”
In part 1 of our article on biocontainment, we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.
Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the third in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.
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