Registration revolves around a seemingly simple question, namely, "What is this thing, and is this thing unique?" In registration of small molecules, this is a fairly simple question because there are generally accepted and well developed standards describing the exact structure of chemical entities and therefore their identity. However, when moving into the biological realm, there is a distinct lack of agreement on what makes two biological entities the same or different. For example, if a protein is expressed in two different cell lines, one scientist may consider them to be the same thing because they share the same amino acid sequence while another scientist may consider them to be different because of different glycosylation patterns. Similarly, in working with cell lines, it is generally accepted that any time a cell line is passaged, it is somewhat different from its parent. However, for practical reasons, many scientists will consider the new batch of cells to be the same as the batch from which they were derived. Of course there are other situations, such as putting a cell line through a limiting dilution, where the individual clonal populations are all considered to be unique.
What these realities of biological entities demonstrate is that, unlike the world of small molecules, rules for identity can be more fluid, and dependent on the needs of specific end-users. As such, a biological registration system must be flexible enough to accommodate different business rules for different needs, yet maintain a reliable backend infrastructure that allows the system to be maintained, supported, and updated. In this talk we will explore this intersection between biological fact and laboratory practice and its influence on how the Accelrys Biological Registration system works, as well as look forward and outline a way to incorporate these hard-learned lessons into future entities or customization of existing entities.