Process Monitoring and Controls

A Future-Proof Solution for Bioprocess Applications: The New Eppendorf Flexible Bioreactor Control System Evolves with the Changing Needs of Modern Biotechnology

In the biopharmaceutical industry’s quality-by-design (QbD) era, optimizing tools for process monitoring and control has become a major focus of development and manufacturing. This increased attention brings challenges into upstream and production processes, cell-line development, process optimization, and scale-up. Suppliers of equipment and technologies also focus on helping their customers improve development timelines. With that increased attention to speed, they are offering tools such as the Eppendorf SciVario twin bioreactor control system to streamline development and maximize flexibility. BPI spoke…

Trends in Data Analytics As Organizations Undergo a Digital Transformation

The biopharmaceutical industry is in the midst of an exciting transformation as biologics experience massive growth — even outpacing the small-molecule segment (1). Biologics are predicted to comprise over a quarter of the pharmaceutical market in 2020 (2). At the same time, a plethora of new biologically derived therapy concepts — e.g., cell and gene therapies — are in development. Some biologics classes have become mainstream — e.g., monoclonal antibodies — with biosimilars entering the market and contract manufacturing organizations…

eBook: Automation — The Value of Plug-and-Play Automation in Single-Use Technology

The biopharmaceutical industry’s movement away from large-scale, fixed-tank facilities to flexible facilities featuring single-use technologies (SUTs) has demonstrated the value of modular equipment and agile process design. SUTs have proven to be clear advantages to end users because those technologies enable quick facility build and changeover times. But linking SUT equipment with equally flexible automative technology has been difficult. Herein a group of automation experts from the BioPhorum Operations Group (BPOG) elaborate “plug-and-play” principles and introduce a supervisory control system…

Determining Control Chart Limits for Continued Process Verification with Autocorrelated Data

Control charts are used to assist in process monitoring activities. They use an estimate of central tendency (the overall mean) and variation (the standard deviation). Sample standard deviations (S) tend to underestimate process standard deviations (σ) when they are calculated using limited sample sizes of independent results (1). For this reason, the unbiasing constant c4 is used as a divisor when calculating Shewhart control-chart limits. If data used for control charting are positively autocorrelated, that tends to underestimate σ further…

Building a Bridge Across the “Valley of Death”: Strategies to Help Support Technology Development

On Thursday 6 September 2018 at the annual BioProcess International Conference in Boston, the first “Technology Round Robin Featuring Six Innovative Bioprocess Technologies” was presented in an interactive session with attendees as active participants, asking questions and engaging in conversation with the six featured entrepreneurs. Detailed below, this session was a culmination of several steps in an overall strategy for some of the companies participating. To fully appreciate the launch of new technologies into the bioprocess arena, you first must…

Development and Application of a Simple and One-Point Multiparameter Technique: Monitoring Commercial-Scale Chromatography Process Performance

In commercial-scale biopharmaceutical manufacturing, downstream chromatography steps are still a bottleneck and contribute to significant operational costs (1, 2). Some of those costs are inherent (e.g., resins, large buffer quantities, and cleaning) whereas others are avoidable (e.g., product loss due to rejected lots or deviations that result in production downtime). Maintaining efficient and robust chromatography process performance is therefore critical for minimizing operating costs. To do so, we introduce a simple and one-point multiparameter technique (SOP-MPT) for monitoring chromatographic process…

Improving Bioreactor Performance Measuring Dissolved Oxygen to Determine kLa

In recent years the biopharmaceutical industry has significantly increased the demands it makes on bioreactor systems. Efficient and reproducible production of active pharmaceuticals of high quality and in large quantities is of highest priority. However, bioprocessing is a complex topic. Numerous factors affect growth of cells in culture but are difficult to determine and interpret reliably. One of the most relevant performance parameters is the volumetric mass transfer coefficient (kLa). It describes the efficiency of gas transfer (e.g., oxygen) from…

Single-Use Sensors and Control and Data Acquisition Tools to Streamline Bioprocess Development

Process development and biomanufacturing in the biopharmaceutical industry have evolved extensively over the past 10 years. More tools are available to study process variables to enable more efficient and productive processes, speed development, and reduce costs. High powered microcontrollers are embedded in laboratory devices to carry out complex tasks. Recently, users have started working with microcontrollers such as Raspberry Pi for personal projects. As personal computer power has accelerated multiplefold,leading to high processing power and compact, high-capacity memory readily available…

Big Biotech Data: Implementing Large-Scale Data Processing and Analysis for Bioprocessing

Managing large amounts of data presents biopharmaceutical companies of all sizes with the need to adopt more efficient ways to handle the ongoing influx of information. At KNect365’s September 2017 Cell and Gene Therapy conference in Boston, Lisa Graham (founder and chief executive officer of Alkemy Innovation, Inc. in Bend, OR) spoke about the need for data management, data analysis, and process monitoring systems to evolve. Although she was speaking at a cell therapy event, her points are applicable to…

In-Line Turbidity Sensors for Monitoring Process Streams in Continuous Countercurrent Tangential Chromatography (CCTC)

A strong connection between turbidity and total suspended solids (TSS) has been linked in the past to measuring well defined particles in processes. Optical density probes have seen wide adoption in the biotechnology industry for monitoring cell growth within a bioreactor, whereas in-line turbidity sensors have been used to monitor filter performance. Turbidity measurements offer a rapid quantification of suspended solids but have not been used in the biotechnology industry for chromatographic resins. In this study, turbidity measured with equipment developed by PendoTECH was used with novel continuous chromatography technology developed by Chromatan…