Tag: <span>tissue engineering</span>

A considerable clinical need exists for alternatives to the autologous vein and artery tissues used for vascular reconstructive surgeries such as coronary artery bypass graft (CABG), lower limb bypass, arteriovenous shunts, and repair of congenital defects to coronary circulation. So far, devices made from synthetic materials have not matched the ¬≠efficacy of native grafts, particularly in small diameter applications. Recent advances in cell biology and tissue engineering have introduced the possibility of a living, biological graft that might mimic the functional properties of native ¬≠vessels…

Biologics Production Regulatory

Electrosprays and electrospinning are two interrelated physical phenomena which have been investigated for well over a century. Their similarity is based upon the primary driving mechanism; namely, the applied electric field. However, they have a fundamental difference that distinguishes one from the other: the former generates droplets while the latter forms continuous fibres. These two processing routes have been extensively researched in many areas. Within the realm of life sciences, these routes have ranged from novel bioanalytical approaches (DNA and biomolecules) to tissue engineering by the formation of scaffolds, which mimic extracellular matrices. Only lately have these methods been explored for the direct process handling of living cells…

Biologics Production

Controlled cell deposition by way of micrometer-sized jets are increasingly becoming a fiercely pursued area of research. We recently uncovered the ability to jet living cells using one such jetting methodology, now referred to as bio-electrosprays. This technique has never been explored for processing living cells until now. Electrosprays charge media within a needle, subsequently imposing an external electric field to assist in drawing the media into a micro-jet. The resulting instabilities assist in jet break-up, forming cell-bearing droplets. These droplets containing viable cells could be deposited onto a wide variety of biological and non-biological substrates. In this article, we report our developmental studies into this jet approach with a view to the successful handling and deposition of primary neonatal cardiac myocytes…

Biologics Production

The United States Pharmacopeia (USP) is a 184-year-old organization that has been in the forefront of technology since its inception. From publishing a manual about how to prepare therapeutic potions, USP has evolved into a compendium of standards and information on manufactured pharmaceutical products, with more than 4,000 monographs covering drug substances and biologics, and their dosage forms, excipients, and nutritional supplements. It is not surprising that the USP initiative in cell and gene therapy and tissue engineering has closely followed the emergence of these technologies…

Cell & Gene Therapy Regulatory Risk Analysis and Management

Conventional medical technologies to address tissue and organ dysfunction have resulted in a host of approaches, largely device-based. Examples include maintenance dialysis for renal dysfunction, use of pacemakers, stents, oxygenators, and valves to neutralize the effects of cardiovascular dysfunction, and replacement of large joints with mechanical substitutes. Advances in transplantation science have led to increasing success in replacing diseased kidneys, livers, hearts, pancreata, and lungs. There are, however, significant and severe limitations to these conventional therapies, most notably the demand by a growing and aging population. There is a well-recognized limitation in the supply of tissues and organs. In the year 2000, for example, 77,000 people were awaiting organ transplants, while only 23,000 were performed. High tech medicine is costly; U.S. healthcare expenditures as a percent of gross domestic product are expected to reach 16.7% by 2007…

Cell & Gene Therapy

Tissue engineering is an emerging area of biotechnology that will provide replacement tissues for patients, as well as complex, functional biological systems for research and testing in the pharmaceutical industry. A new research area of tissue engineering is the investigation of how living cells interact with and respond to synthetic biomaterial surfaces. The clinical developments that underlie that research include a number of novel tissue-engineered medical products (TEMPs)…

Biologics Production Research