Outsourcing for IVD Manufacturers
Contract manufacturing: In this section
      1. Bioprocessing services prepare and purify the biochemicals and chemical reagents used in IVDs, many of which are particularly hard to culture and grow in laboratory settings. Suppliers use advanced chemical, physical, and biological processes to recover and purify products from dilute process streams. 2. Converters supply industry with die-cut parts, adhesion of liners to pressure-sensitive products, and multilaminated packaging materials in sheet or roll form. 3...
Introduction to contract manufacturing
      The trained associates at NERL Diagnostics Corp. (East Providence, RI) carefully inspect each bottle to maintain high quality control standards. In today's IVD market, as in other segments of the medical product manufacturing industry, change is a constant. A significant large-scale change is the pace at which both large diagnostic companies and numerous smaller start-ups and biotechnology companies are enthusiastically embracing the benefits of contract...
Using specialty labs to develop IVDs
    Developing an IVD assay with broad utility as a routine clinical diagnostic requires numerous resources and skill sets. Since IVD manufacturers may lack direct access to all of the resources and expertise required, such as knowledge of regulatory requirements for FDA submissions and conducting clinical trials, they may opt to outsource such development services to specialized third-party firms. This article highlights two components of IVD development that can be outsourced to...
A systematic approach to successful transfer of IVD manufacturing technology
In the past, the transfer of IVD manufacturing processes from research and development (R&D) to engineering and production was more art than science. The technology transfer process was, in effect, a passing of the baton, with little or no planning or structure, and few requirements.   The journey from test tube to marketplace has always been a challenge. A carefully devised technology transfer plan can help ease this transition. The actual transfer may have been based solely...
Introduction to Contract Manufacturing
    Automatic fill lines at NERL Diagnostics (East Providence, RI) speed bottles and other products through to completion. In today's IVD market, as in other segments of the medical product manufacturing industry, change is a constant. A significant large-scale change is the pace at which both large diagnostic companies and numerous smaller start-ups and biotechnology companies are enthusiastically embracing the benefits of contract manufacturing, outsourcing production and...
Contract Manufacturing: In this section
    1. Bioprocessing services prepare and purify the biochemicals and chemical reagents used in IVDs, many of which are particularly hard to culture and grow in laboratory settings. Suppliers use advanced chemical, physical, and biological processes to recover and purify products from dilute process streams. 2. Converters supply industry with die-cut parts, adhesion of liners to pressure-sensitive products, and multilaminated packaging materials in sheet or roll form. 3. Dispensing...
Manufacturing equipment and supplies: In this section
    1. Adhesives, coatings, and solvents companies offer a wide range of such materials for use in product assembly. New adhesives and coatings are constantly being developed to improve product performance. Recent advances in cyanoacrylates and UV or visible-light curing adhesives make them worth consideration. 2. Automation/custom systems suppliers can design and fabricate equipment for converting, assembly, inspection, and packaging of diagnostic products. Such systems are built in...
Immunoassay development partnerships
    The medical diagnostics industry today faces numerous economic and technical challenges. From regulatory requirements to price pressures, these challenges are changing the way IVD companies bring new products, such as laboratory tests, to market. Now, more than ever, IVD companies must find faster, high-quality, cost-effective ways to provide a broad menu of diagnostic tests. One common way to add menu quickly is through codevelopment agreements with other companies....
Introduction to contract manufacturing
Trained associates at NERL Diagnostics (East Providence, RI) carefully inspect each bottle to maintain high quality control standards. In today’s competitive environment, outsourcing is becoming an attractive option for IVD manufacturers. As the pace and complexity of new product development, manufacturing, and supply continue to accelerate, manufacturers are finding it difficult to stay ahead and conduct global launches without support from other organizations. IVD companies may...
Contract manufacturing: In this section
    1. Bioprocessing services prepare and purify the biochemicals and chemical reagents used in IVDs, many of which are particularly hard to culture and grow in laboratory settings. Suppliers use advanced chemical, physical, and biological processes to recover and purify products from dilute process streams. 2. Converters supply industry with die-cut parts, adhesion of liners to pressure-sensitive products, and multilaminated packaging materials in sheet or roll form. 3. Dispensing...