Microcarriers designed for protein & sera free media

描述(申请人提供)：这项SBIR第二阶段申请的总体目标是开发一系列微载体产品，使合成或重组胶原蛋白多肽结合到珠子表面。这些微载体产品将取代目前将猪胶原(即明胶)作为附着表面一部分的微载体。合成的胶原蛋白多肽涂层微载体将是在无动物产品制造方案中替代现有产品的理想选择。目前，在锚定依赖细胞的工业化生产中，三种胶原涂层微载体(离岸生产的胶原涂层葡聚糖珠[Cytodex 3]和SoloHill的两种明胶涂层微载体)是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走向完全不含动物产品的生产条件，含有胶原或明胶的底物将是不可接受的。具有合成胶原蛋白多肽涂层表面的微载体将提供理想的替代品。这里所述的第二阶段研究是继第一阶段取得的成功之后进行的。第二阶段工作计划分为三个总体具体目标。 具体目的1.开发一种表面带有合成胶原肽的微载体。这种微载体将是一种不含动物产品的等价物(在某些应用中是SoloHill明胶涂层微载体的替代品)。 具体目的II.研制一种表面带有合成胶原肽的葡聚糖微载体。这种微载体将是一种不含动物产品的微载体，相当于(或替代)目前由外国竞争对手制造和销售的胶原蛋白连接的葡聚糖微载体。 具体目标三。目的：探讨添加微载体合成表面涂层替代现有猪明胶表面涂层的应用。例如，对目前合成的胶原蛋白多肽和重组人胶原蛋白和明胶进行修饰。

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.