October 2009

Shrinking the Costs of Bioprocess Development

Process development for large-scale bioproduction is generally more labor-intensive, time-consuming, and expensive than for comparable nonbiological processes because of the large number of individual processes and potential variables involved. To ensure the future commercial viability of biological manufacturing processes and prevent bottlenecks, it is essential to accelerate development of both upstream and downstream processing, as well as to improve process analytics. This not only reduces time and cost factors involved in design of robust bioprocessing protocols, but also reduces the…

DoE Helps Optimize a Cell Culture Bioproduction System

    Typical serum-free culture media used in bioprocessing can have 60–90 components at differing concentrations to feed a single cell line. Media used to grow different cell lines for bioprocessing applications may each require unique optimal chemical formulations. Adding complexity, optimal process conditions such as pH and stirring rate may also differ from cell line to cell line depending on the unique characteristics of process performance. To tackle all those variables, we at Invitrogen Corporation of Carlsbad, CA (www.invitrogen.com/pddirect)…

Creation of a Well Characterized Small Scale Model for High-Throughput Process Development

    Streamlining process development has been the focus of the biotechnology industry over the past several years. To be financially viable in the current market, a company has to be competitive in all three of the following areas: quality, speed, and price (1). Attaining any two of the three attributes at a time is no longer sufficient. With new tools and technologies along with improved understanding of the cell-culture process, doing high-quality process development while reducing both cycle time…

Software Simplifies Accounting for Batch Genealogy

    As an updated US FDA guidance document emphasizes, the life sciences industry needs to use data to better understand manufacturing processes and sources of variation to minimize product risk and achieve better process control in future batches (1). Lessons learned through such efforts also can be applied to future process design, extending the value of data analysis. Bioprocess manufacturers typically rely on lot traceability to determine the composition of their final manufactured products. Lot traceability is only one…