Today’s biotechnology industry faces intense pressure to improve manufacturing performance. Process industry manufacturers have always been challenged to find ways to improve product quality, prevent product loss and improve yields, and today’s escalating health care costs only exacerbate those challenges for biotech firms. The loss of product throughput or work in progress can be extremely costly, exceeding millions of dollars.
Early detection and identification of the root cause of process upsets using advanced multivariate analysis (MVA) techniques provides significant economic benefits and cost savings by helping to improve product quality and consistency and avoiding product losses or rework.
Biogen Idec, a global biotechnology company, has been using MVA for commercial and clinical campaigns for several years. The rollout of SIMCA Batch On-Line (SBOL) from Swedish software maker Umetrics (www.umetrics.com) allowed the company to monitor and better control its manufacturing processes in real time and near real time. The company’s successful rollout of this technology is due, in large part, to its culture, talented employees, support from management, and partnerships with its MVA supplier.
Early fault detection
Prior to multivariate statistical process control (MSPC), Biogen Idec required different methods and tools to improve process understanding, detect process upsets, and allow for corrective actions. The rollout of this technology to manufacturing allowed the company to monitor and control its manufacturing processes in real time. MSPC enables operators, engineers and other manufacturing personnel to increase their process knowledge and take proactive steps to prevent potential problems. Using MSPC, the company can compare current product batches against the “golden batch” created from historical data to make decisions to ensure quality and prevent loss of batches.
Biogen Idec uses MVA to create models and increase efficiencies. This improves batch-to-batch consistency and reduces batch cycle times to save energy and increase throughput. The software analyzes the real-time data that is collected across processes and batches, and uses the results of the analysis to adjust and optimize the system in real-time.
The models provide the company with equipment, process and hierarchical views of the process. With the software in place, operators can see excursions, troubleshoot, understand problems, and make better and timelier decisions. The company has expanded the monitoring capability throughout the biologics production process and found that the software has improved its processing performance.
Biogen Idec uses chromatography to separate and purify its products. Chromatography is an important and essential part of the biotech manufacturing process that has a significant impact on the bottom line. Since it’s very difficult (at best) to automate chromatography production operations, the company uses Umetrics advanced control software to improve its ability to monitor the operation in real time, including monitoring batch-to-batch consistency. By analyzing the relationship between variables in each batch and from batch to batch, the MVA software can determine the simultaneous and combined effects of each variable and detect perturbations.
These multivariate analysis implementations have been highly successful and Biogen Idec plans to continue to expand the use and applications throughout its manufacturing operations. It stresses the importance of training to train employees and operators on MVA. It is also extremely important to have top management buy-in for an MVA solution. Provided with appropriate empowerment, operators can use these tools to recognize and prevent problems and can be proactive in solving issues before they become problems. MVA has the power to provide insight into what is going in the process and prevent potential problems to help improve profitability.
Janice Abel, firstname.lastname@example.org, is principal consultant at ARC Advisory Group in Dedham, Mass.