In a recent discussion with Jay Robleski, associate director of quality control at Mustang Bio, he talked about various aspects of the current revolution in the bioprocessing industry. The firm is a clinical stage biopharmaceutical company focused on evaluating cell and gene therapies for hematologic cancers, solid tumors, and rare genetic diseases.
“Mustang Bio approaches each process starting from a paper-based system and works it forward into the Bioprocessing 4.0 model,” he said. “Manufacturing and testing processes are created and once they are fully optimized, they are converted into electronic systems. As more patients are treated by Mustang Bio, critical integrated systems will be the key to maintaining our business model.”
As the development train progresses, release testing is performed by the QC lab. The data form the basis of the Certificate of Analysis, executed manually through a paper-based system. Mustang Bio has a contractual agreement in place with Thermo Fisher Scientific to build and bring onsite a fully validated GMP LIMS known as Thermo Scientific Sample Manager LIMSTM software. This system will be set up to track all release testing, environmental monitoring tasks, and stability studies.
Its purpose is to ensure that all reagents and equipment are used within their expiration or calibration dates, that all calculations are executed in an accurate and repeatable fashion, and finally that the process follows any trends that may surface in real time for release testing. SampleManager LIMS software will also ensure all environmental monitoring sites are sampled within a given time period and immediately flagged for action or alert limits, noted Robleski.
Although Mustang is at clinical stages now and manufacturing throughput is low, this configuration will help reduce potential sources of human error, he continued, adding that this will in turn help reduce the reviewing hours required from employees and allow Mustang to function at a high throughput when the time is needed.
There is grave concern over the ability of the industry to meet production challenges posed by the Coronavirus COVID-19 threat and the need to ramp of production rapidly. In reply to the question if he feels the industry is poised to meet this formidable challenge, Robleski responded that “I believe the industry can accommodate the recommendations made by the WHO and CDC, and still meet our primary mission of manufacturing for patients’ needs.”
Bioprocessing 4.0 is neither a buzz word nor a quantum leap, but rather another tool in the data collection process, he explained. “However, no matter how automated or how thoroughly based upon artificial intelligence, our industry will rely on people and processes founded upon key indicators,” Robleski said. “The methodologies our industries have used in the past—‘Bioprocessing 1.0’—have grown and evolved into Bioprocessing 4.0. In the future, novel science and technology will be exploited to drive Biomanufacturing 5.0 and higher.”