cialization cost?” and “Will faster decisions on the production floor reduce waste?”
Development of advanced analytics is making it possible to monitor and release products in real time.
Rapid adoption of single-use disposable technologies has reduced the number of routine manual interventions for cleaning, sterilization, and similar operations.
Autologous cell therapies and gene therapies for rare diseases require smaller volumes, and bench-scale equipment is typically used.
A Workforce Transformed
Given these trends, it’s advantageous for companies to build organizations in which production personnel understand underlying scientific and engineering principles that support bioprocesses and can react quickly to manufacturing deviations. In bioprocessing operations that use large, highly automated stainless steel equipment (e.g., for production of monoclonal antibodies), technicians with a background in science will be able to troubleshoot problems and make corrective actions in real time without help from support staff. The growth of advanced analytics and process analytical technology (PAT) is producing more process data, but until every deviation can be predicted and every corrective action can be programmed, the bioprocess technicians’ jobs will become more challenging (1).
Autologous cell therapies and gene therapies for rare diseases require smaller volumes than for production of monoclonal antibodies and often can often use single-use technologies that are facilitate operations. With these products, research scientists can be given a greater role in shepherding a therapy through its life cycle — all the way to the production line. With this goal in mind, a scientist can focus development activities on establishing a commercial manufacturing process capable of consistently producing the specified drug substance according to ICH Q8 (2). Outputs include critical quality attributes, design space, and control strategy. PAT strategy can be developed here, as well. At this point, it would be natural for a scientist to move on to learn about process performance qualification and then production. Such a workflow reduces the time required to commercialize a product and shortens the cycle time to produce each batch, especially when process failures occur.
Bioprocesses of the future will demand more from production personnel. By necessity, autologous therapies require a greater number of production batches. On a given work shift, a great number of critical operations can affect a batch. Because single-use technologies require fewer manual operations than does traditional equipment (e.g., cleaning and sterilization), the proportion of critical operations per shift also will increase. In either case, additional process knowledge will be needed during production.
So How Do We Get There?
Education, recruitment, and training are the interconnected routes to building product and process knowledge.
Education: Students interested in entering the biomanufacturing industry need to learn and understand biology, microbiology, molecular biology, chemistry, and biochemistry. Those who want multiple job offers will supplement their studies with courses on fermentation, cell culture, downstream operations, automation, aseptic processing, and quality principles. Regulatory science, automation and professional skills also are helpful.
Universities are well suited to offer both introductory and advanced courses in scientific principles. Where such programs exist, most include hands-on laboratory activities to support the curricula. Students majoring in the life sciences can be introduced to bioprocessing careers — especially manufacturing positions — during their first year of study. Upperclassmen then can choose electives relevant to drug substance manufacturing and, if available, obtain a major, minor, or certificate in bioprocessing. Graduate courses in bioprocessing can supplement other programs or lead to a master’s degree.
Community college programs also need to deliver introductory courses, hands-on laboratory activities, and career educa