The adoption of next generation bioprocessing is reaching an inflection point as biopharmaceutical companies rally around new manufacturing methods, which are considered essential to the industry's continued growth and innovation. Next generation bioprocessing strives to increase the efficiency and agility of biopharmaceutical manufacturing, without sacrificing quality, while reducing capital and operational costs, time to market and risk.
In the early stages of this paradigm shift, process intensification can be achieved both in upstream and downstream operations. Upstream processes are becoming more productive as the fed-batch mode is replaced with perfusion, and downstream bottlenecks are being eased, for example, as multi-column Protein A chromatography is employed. Ultimately, though, the greatest efficiencies will come from fully connected and continuous processing.
Within the next five to ten years, about 35% of today's biologics will be manufactured using process intensification methods, according to a MilliporeSigma market analysis. By that time, the facilities will be smaller but capable of processing higher volumes and multiple molecules. The key to this advancement will be single-use technologies that enable reductions in facility size, cycle times and environmental impact. These benefits, in turn, reduce capital investment, operational costs and build time, which will be trimmed from roughly five years to as little as 18 months.
Merrilee Whitney, head of next generation bioprocessing at MilliporeSigma, says that "existing bioprocessing methods have pushed us as far as we can go. New technologies, methodologies and a mind shift will be necessary if we are to move to fully connected and continuous bioprocessing." Accordingly, she defines next generation processing as any technology or system that "delivers higher productivity, increased manufacturing flexibility, increased speed and reduced risk."
This process won’t happen overnight but will undergo "an evolutionary adoption within the industry," adds Whitney.
This evolution will require culture change in the biopharmaceutical world, and everyone from manufacturers and vendors to regulators will need to be involved. If biomanufacturers are to remain competitive, they should collaborate with vendors and regulators to become early adopters and efficient users.
Building Collaborative Resources Across the Industry
Dr. Helge Berg, director of technology management for MilliporeSigma's M Lab™ Collaboration Centers, considers collaboration and education to be crucial as the industry moves to a continuous bioprocessing environment. Recognizing the role of M Lab™ Collaboration Centers in the education, adoption and implementation of next generation processing, he says, "We have a mandate to actively help move academics, the industry and regulatory agencies forward in a very open, collaborative way."
Dr. Berg describes the nine M Lab™ Collaboration Centers around the world as "sandboxes or playgrounds for the industry to come and experience existing technology and explore how connected unit operations and intensification work together." For example, a new hands-on and theoretical course focusing on continuous and intensified processing in upstream cell culture will be launched at the M Lab™ Collaboration Center in France later this year followed by a launch in North America in May 2019.
Industry stakeholders are coming together to share knowledge and expertise, explore new processes, and advance a culture of innovation.
One prime example of this collaborative effort is the landmark Horizon 2020 initiative, which funds a consortium of seven members — including MilliporeSigma, Lek Pharmaceuticals (Sandoz), several academic partners, as well as small and medium-sized enterprises — working on a project called "Next generation biopharmaceutical downstream process."
The consortium strives to reduce the size and number of downstream unit operations, eliminate centrifugation to improve efficiency, and reduce the need for the costly Protein A chromatography step by replacing it with capture via precipitation.
There are also new industry organizations being established to help bring advanced technologies to fruition. One of these is the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Tier 1 members of the group include MilliporeSigma and its parent company Merck KGaA, Darmstadt, Germany. Launched March 1, 2017, with a $70 million collaborative agreement over five years, NIIMBL is bringing the biopharmaceutical industry together with top-flight research universities, key federal agencies, nonprofits and trade groups expressly to “develop high-impact biomanufacturing innovations” in the U.S.
All told, it’s a vibrant time for collaboration and education, according to Whitney, with "multiple conversations across the industry and a very high level of engagement through organizations, associations, regulators and conferences."
What is Horizon 2020?
Backed by the European Commission in 2014, the Horizon 2020 initiative is the most extensive European Union research and innovation program funded to date, with nearly €80 billion allocated over the period from 2014 to 2020, augmented by substantial private investment. With the support of Europe’s leaders and the European Parliament, Horizon 2020 stresses world-class science, elimination of barriers to innovation, and industrial leadership in knowledge, research and innovation.