October 2009

Promoting Discussion in the Biopharmaceutical Community

The Biopharmaceutical Emerging Best Practices Association (BEBPA) hit the scene in September 2008 with its inaugural Bioassay Conference in Berlin, Germany. A not-for-profit association, BEBPA (www.bebpa.org) is managed by the biopharmaceutical scientific community for the benefit of the biopharmaceutical scientific community: companies, regulators, and clinicians. BEBPA provides an open international forum for the presentation and discussion of scientific issues and problems encountered in the biopharmaceutical community. The purpose of this open discussion is to promote development of innovative approaches and…

The Need for a New Process

Surveying BPI readers’ experiences SANJA GJENERO (WWW.SXC.HU) Better, faster, safer: The current drug-development “paradigm” emerging from the FDA is pushing for innovations that reduce process inefficiency and cost. The plethora of new risk-based methodologies include tools being developed as process-analytical-technology (PAT) tools within the encircling parameters of a process design space. All this parallels (and drives) some predictions that the biotechnology industry has seen the last of its blockbuster models, as predictive genomic tools enable personalized approaches to therapeutic development.…

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…

Putting All the Pieces Together

Most people in the industry are struggling with quality by design and how it relates to the acceleration of process development. Many are confused by the new FDA approach to bioprocess development, unsure of the specific implications of QbD on the CMC section of their marketing applications, and unclear how the risk-based approach applies to their particular operations. Some have trouble understanding the precise link between CQA and CPPs under a life-cycle approach and are stuck considering the exact definitions…

Sailing Through Pharmaceutical Risk Management

The New World In 2002, responding to public outrage over a series of corporate accounting scandals, the US Congress enacted a law now generally referred to as “Sarbanes–Oxley” or SOX (2). Under this law, the US Securities and Exchange Commission (SEC) issued regulations defining new requirements. Promulgated for misdeeds arising in the financial sector and driven by the SEC, most analysts now view this legislation as financially unifunctional. The growing complexity of business organizations, however, and the interdependency of their…

50 Years of Sephadex Media

It has been 50 years since the first Sephadex paper was published (1). Readers of BioProcess International work in a field that was fundamentally affected by what happened after that paper appeared in 1959. So this anniversary is certainly worthy of a party and a few speeches. But there are lessons to be learned, too. Here we take a look at threads connecting events before and after the discovery of gel filtration chromatography and introduction of the Sephadex product. Interdisciplinary…

Large-Scale Freezing of Biologics

Production of biologics is an expensive process, and to optimize capacity use, bulk protein solution is often produced in manufacturing campaigns. It is converted into drug product based on market demand and therefore may have to be stored for relatively long periods. To decouple the bulk solution production from that of the final drug product, bulk is often stored frozen. Transport of frozen bulk product between sites offers several practical advantages over its transport in the liquid state (2–8 °C).…