Information Technology

Intellectual Property Protection in the Digital Age

    For most biotechnology and biopharmaceutical organizations, “business as usual” means a perpetual race to the finish line: Conceive a new invention, reduce it to practice, attain patent protection, repeat ad infinitum. But sometimes, the very technologies scientists use to expedite that chain of events (e.g., electronic laboratory notebooks and cloud-based laboratory data sharing) create security and authenticity holes. In essence, the more agile and sophisticated our work flow systems become, the more difficult it becomes to guarantee the…

Practical Considerations for DoE Implementation in Quality By Design

    It is generally accepted that quality cannot be tested or inspected into a finished product, but rather that quality, safety, and effectiveness must be “designed” and built into a product and its manufacturing process. To encourage new initiatives and provide guidance to pharmaceutical process developers, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use introduced the quality by design (QbD) concept. ICH-Q8 defines it as “a systematic approach to development that begins…

A Smarter Approach to Biomanufacturing

    Mergers and acquisitions have long been a staple of the life sciences industry — a reality that has resulted in disparate information technology (IT) environments within and across often far-flung enterprises. The situation is particularly prevalent in manufacturing operations because a pharmaceutical or biotechnology organization may run different management systems in nearly every separate facility (especially when contract manufacturers are involved). These “siloed” information environments are hindering efforts to evaluate and improve quality and operational efficiency at a…

Biopharmaceutical Information Infrastructure 2.0

    This two-part article explores related tools and technologies that biopharmaceutical companies can leverage to build an efficient mechanism for capturing and delivering valuable information. In BioProcess International’s December 2009 issue, part 1 of the series focused on infrastructure selection and how hardware, software, and information systems form a kind of ecosystem (1). Simplicity, sustainability, and scalability can be achieved only when that trio is designed holistically. Part 1 further explored structured data capture and analysis tools, whereas this…

Biopharmaceutical Information Infrastructure 2.0

Availability of the right information to the right people at right time is critical for understanding and improving existing processes within an organization. For a data-intensive industry such as biopharmaceuticals development and manufacturing, access to data and information enables companies to understand and streamline their operating and business processes. But most organizations fail to leverage such information for better decisions because they mismanage it. Some try to fill the gap between information and end users by introducing various applications and…

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…

Modeling Flow Distribution in Large-Scale Chromatographic Columns with Computational Fluid Dynamics

Column chromatography remains a key unit operation in downstream processing of biopharmaceuticals. For most commercial processes, two to three chromatography steps are used to remove process-and product-related proteins, DNA and adventitious agents. As the biopharmaceutical industry has increased its product offerings and related demands, downstream processes have fast become a bottleneck (1, 2). Many commercial and clinical processes include a number of cycles on one or more chromatography steps to process the harvest from a single production batch. PRODUCT FOCUS:…

Data Management in the Supply Chain

Adopting an effective strategy for data and knowledge management throughout the drug development and clinical manufacturing lifecycle is key to maintaining a competitive edge. Significant challenges face each organization seeking to improve efficiency in this area, and they can mostly be attributed to the complex nature of pharmaceutical drug development. Managing both data and knowledge is complicated by the different groups, sites, and partner organizations involved with developing and manufacturing a new drug product. To further compound the problem, a…

In the Information Technology Zone

Successfully driving your global business requires vigorous, secure information exchange within your facility, from site-to-site, and with your partners and contract service providers. Tools to capture data in real time support decision making and enable companies to manage volumes of historical data needed for regulatory submissions. Software is available for data mining, managing clinical trial networks, and assessing toxicology data (among many other things). Information technologies in the biotechnology industry facilitate development and delivery of new therapies and diagnostics, improvements…