Microcarriers designed for protein & sera free media

描述（由申请人提供）：该SBIR II期申请的总体目标是开发一系列微载体产品，这些产品具有合成或重组胶原肽结合到珠表面。这些微载体产品将取代目前以猪胶原蛋白（即明胶）作为附着表面的微载体。合成的胶原蛋白肽包被微载体将成为无动物产品生产方案中现有产品的理想替代品。目前，三种胶原包被微载体（离岸公司生产的胶原包被葡聚糖珠[Cytodex 3]和SoloHill公司的两种明胶包被微载体）是在锚定依赖细胞的工业规模生产中使用最广泛的微载体底物。随着病毒疫苗和其他生物制品的制造商逐渐转向完全不含动物产品的生产条件，含有胶原蛋白或明胶的底物将不可接受。微载体与合成胶原肽包被表面将提供理想的替代品。这里所述的第二阶段研究直接继承了第一阶段所取得的成功。第二阶段工作计划分为三个总体具体目标。

DESCRIPTION (provided by applicant): The overall goal of this SBIR Phase II application is to develop a family of microcarrier products that have a synthetic or recombinant collagen peptide bound to the bead surface. These microcarrier products would replace current microcarriers that have porcine collagen (i.e., gelatin) as part of the attachment surface. The synthetic collagen peptide-coated microcarriers would be an ideal replacement for existing products in animal product-free manufacturing protocols. Currently, three collagen-coated microcarriers, (a collagen-coated dextran bead [Cytodex 3] manufactured offshore and SoloHill's two gelatin-coated microcarriers) are the most extensively used microcarrier substrates in the industrial scale production of anchorage-dependent cells. As manufacturers of viral vaccines and other biologicals move toward complete animal product-free manufacturing conditions, a substrate containing collagen or gelatin will not be acceptable. Microcarriers with a synthetic collagen peptide - coated surface would provide an ideal replacement. The Phase II studies described here follow directly from the successes achieved in Phase I. The Phase II work plan is divided into three overall specific aims. Specific Aim I. To develop a microcarrier that has a synthetic collagen peptide on its surface. This microcarrier would be an animal product-free equivalent of (and in some applications a replacement for) the SoloHill gelatin-coated microcarriers. Specific Aim II. To develop a dextran microcarrier that has a synthetic collagen peptide on its surface. This microcarrier would be an animal product-free equivalent of (and a replacement for) the collagen-linked dextran microcarriers now manufactured and sold by a foreign competitor. Specific Aim IIl. To investigate the utility of additional microcarrier synthetic surface coatings as replacements of current products with porcine gelatin on the surface. Examples are modifications to the current synthetic collagen peptide and recombinant human collagen and gelatins.