Over the years, bioprocessing companies have leveraged a host of information technology (IT) to help them bring innovative new therapies to market. As the needs of a research and development (R&D) enterprise evolve, however, are such systems and applications a help or a hindrance? On one hand, the increasing sophistication of IT solutions — such as those designed to help users create advanced molecular models or track thousands of compounds through the discovery process — have enabled new…
Information Technology
Approaches to Debottlenecking and Process Optimization
Two major challenges associated with optimizing biomanufacturing operations remain unresolved. The first is variability: how to understand and improve manufacturing with significant variation in process times throughout all unit operations. The second is complexity: modern biomanufacturing facilities are complex and interconnected, with piping segments, transfer panels, and valve arrays, as well as water for injection (WFI) and other shared resource constraints. That complexity is becoming even greater with the need for process standardization and processing of higher (and…
Manufacturing Process Automation
When you think of futuristic manufacturing facilities and processes, robots might come to mind in a science fiction setting where humans are absent and production lines are directed by computerized drones that perform tasks we can’t even imagine today. As the pace of technology shuttles us swiftly into the real future, however, life-science manufacturers need to pause to examine the purpose of automation and how we can best steer its course. In bioprocess manufacturing and other industries, technology is growing…
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:…