New education program to accelerate industry next-gen processing
Bioprocessing industry challenges drive new training needs
As the bioprocessing industry expands, and more companies transition from traditional fed-batch to continuous upstream processing, they are adopting next-generation technologies such as continuous manufacturing. These advanced techniques in cell line and cell culture media processing can produce unprecedented opportunities for process efficiencies and cost savings. But proactive employee education is key to getting the most out of these new upstream processing technologies.
The need for employee training on next-generation processes spans companies operating in emerging markets, well-established companies that are shifting from traditional fed-batch processes to intensified processes, as well as companies seeking to adopt new upstream processing techniques in anticipation of entering new markets.
Employee training can also translate into improved communications between teams and divisions. This aspect is particularly critical as organizations implement next-generation technologies to create new products and streamline their operations across departments.
"Employee education can be a great tool for accelerating industry implementation of next-generation processing techniques," says Gorazd Hribar, senior scientist and project manager of the NextBioPharmDSP project at Novartis. "Training employees in practical problem-solving so they can proactively solve implementation issues in these new processing technologies can make adoption much easier. With the rapid expansion of the biotechnology industry, manufacturers need trained talent."
These next-generation technologies may eventually enable an entirely different model of biologics manufacturing. While manufacturing is currently centralized, future biologics may be produced at smaller, flexible plants using single-use technology at geographically-dispersed facilities. The efficiencies that process intensification provides could enable more cost-effective manufacturing of orphan drugs, potentially in portable plants, for example.
Whatever the future brings, a cohesive program of employee training can help companies navigate not only these changes but certain knowledge gaps in emerging technologies that can impede production efficiency, according to Delia Lyons, head of perfusion media development, MilliporeSigma. “Traditionally, you had people who would specialize in either upstream or downstream operations,” Lyons says. “Now, continuous manufacturing is linking upstream and downstream processes. I think this linkage increases the need for a better understanding cross-functionally when you talk across departments.”
Lyons points out that training can help experts in downstream technology more effectively communicate with their upstream counterparts and vice versa. For instance, during perfusion – a continuous process in which cells are retained in the bioreactor while spent media, usually containing the protein of interest, is continuously removed from the bioreactor and the bioreactor is being replenished proportionally with fresh media – communication between upstream and downstream teams is essential.
Coordinated communication between workgroups is also necessary to effectively implement process intensification. This related method uses perfusion processes to generate extremely high cell densities to obtain high protein production. Implementing process intensification can significantly reduce processing costs, but only if you have the right media, Lyons emphasizes. Process intensification and the use of smaller bioreactors can provide flexibility while reducing the seed train process.
However, to get the full benefit from intensified processes, upstream industry experts need training. "There is definitely a learning curve there," Lyons says. "If you are an expert in fed-batch, how do you transfer it into intensified perfusion? How do you know when to use what? We are aiming to help the industry."
A three-part model of cell culture education
Mastering new perfusion and process intensification technologies mean acquiring proficiency in both theoretical knowledge and practical skills. Based on deep experience working closely with multiple companies implementing processes involving a variety of intensified and continuous manufacturing capabilities, MilliporeSigma has developed a targeted three-day program that integrates foundational and operational knowledge with the opportunity for practical experimentation and review.
“In the intensified-type work, we are leading the industry, especially in the media side where we were first to market, and at the moment are offering the only commercially available specialized cell culture media,” says Lyons. “Using our experience, we have been facilitating learning for different professionals to reduce their learning curve. Instead of one-on-one “offline” tutorials, MilliporeSigma’s training course offers a more structured opportunity to train people methodically.”
The course, “Continuous and Intensified Processing in Upstream Cell Culture,” combines lecture and laboratory classroom training with hands-on problem solving and simulations in MilliporeSigma’s M Lab™ Collaboration Centers where employees acquire the tools to apply and troubleshoot new bioprocessing technologies, equipment and techniques.
The curriculum spans the entire upstream process. Instructors with real-world industry experience cover critical concepts in upstream animal cell culture technology, including key issues in cell line development, critical concepts in cell culture media development and bioreactor operation and scalability. They also focus on practical applications of continuous processing techniques, including perfusion and process intensification. “We have done a lot of work with intensified processes,” says Lyons. “There are a lot of tricks behind these techniques that you cannot learn by reading. This training is independent of our products and given at a scientific level. The M Lab™ Collaboration Center has all the tools students need to have an intensive, hands-on learning experience.”
The importance of hands-on education: The M Lab™ Collaboration Centers
Participants reinforce their foundational and conceptual learning by practicing scientific problem-solving inside MilliporeSigma’s global network of M Lab™ Collaboration Centers. The M Lab™ Collaboration Centers are non-GMP facilities designed for hands-on training that simulate a real manufacturing environment across the entire process train, from upstream to downstream and through the final fill.
Who can benefit from this training?
As upstream and downstream processes become more integrated, an inclusive program of worker training is essential to overcome any cross-functional gaps in knowledge. While this training program is meant primarily for upstream employees to familiarize themselves with next-generation processing technologies, it can also benefit downstream employees. The conceptual knowledge and hands-on practice this course provides can also assist employees in other areas such as finance, business development and regulatory affairs who may already have an understanding of traditional legacy processes in their work, but are now faced with a new layer of complexity. “Now you have a continuous process, you have regulatory agencies trying to set new standards,” says Lyons. “This course can help everybody speak the same language.”
MilliporeSigma's Customer Education Program
MilliporeSigma’s new foundational training course: Continuous and Intensified Processing in Upstream Cell Culture. This three-day course covers emerging techniques in upstream processing techniques, including:
- Perfusion systems and their applications such as process intensification techniques
- Recombinant cell lines, cell transfection processes and methods involved in screening cell lines.
- Critical aspects of cell culture media and optimization techniques
- Bioreactor operation for intensified processes and its scalability
- Cell retention devices
Course content will include practical training in:
- Cell-Line development, transfection and cell metabolism: Students will learn and practice some of the common methods used to engineer and develop cell lines, along with how to determine critical Go/No-Go decision points, and how to troubleshoot common issues and technical difficulties.
- Cell culture media: Students will learn about the critical components of cell culture media, methods of optimization, principles of hydration, mixing and filter sizing.
- Bioreactors: Basic operation of bioreactor, perfusion devices and assemblies, in which students will take samples from bioreactors, study metabolites, interpret data, recognize warning signs and troubleshoot problems.