Tapping into collective intelligence: Why collaboration is critical for the adoption and implementation of next-generation bioprocessing
Next-generation bioprocessing is a step-by-step evolution already well underway as the pharma industry undergoes a paradigm shift toward continuous processing. But companies don’t need to work in isolation; they can enhance their capacity to adapt to change and develop the necessary new technologies through fostering a robust extended network of partnerships.
Collaborative networks can enable more effective development of next-generation innovations and high-value bioprocessing technologies to meet industry needs. Each participant contributes valuable domain knowledge, strengthening the quality of information exchange. The ongoing feedback that each of these different collaborators provides can reduce uncertainty and “de-risk” the technology development process. These collaborations also assist in accessing ongoing regulatory guidance for successful implementation and validation.
To this end, MilliporeSigma is sharing its experience in building a collaboration network that incorporates a wide range of perspectives. Partners in this diverse network include biomanufacturers of different sizes, industry associations such as the BioPhorum Operations Group (BPOG) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIBML), academic researchers, and regulatory agencies such as the FDA and the European Medicines Agency (EMA).
Advancing biomanufacturing: the supplier-academia-manufacturer relationship
Biomanufacturers already rely on leading suppliers with proven expertise to support them with new technologies. For example, MilliporeSigma actively partners with biomanufacturers to provide them with ongoing access to internal technical experts who keep them apprised of the changing bioprocessing landscape. The third link in the “triangle of collaboration” is academia.
Gorazd Hribar, senior scientist and project manager of the NextBioPharmDSP project at Novartis, notes that current manufacturing processes for biologics are not fully optimized. Many opportunities remain to introduce new technologies that can lead to higher productivity, significant cost reductions and environmental benefits, and, eventually, better accessibility to drugs for patients.
During ongoing and multifaceted technical discussions, biomanufacturers and suppliers listen to one another and exchange feedback that can help improve processes. Indeed, the primary value of this supplier-academia-manufacturer collaboration is that it provides a coordinated framework for collecting and consolidating knowledge from suppliers, tapping drug development expertise from the biopharmaceutical industry, and drawing on the more long-term perspective and creativity of academia. Hribar sees value in manufacturers drawing on suppliers’ expertise early in the product-development process. “It is really beneficial if biomanufacturers can be involved from the start,” he says.
Michael Phillips, director, Next Generation Processing R&D at MilliporeSigma, says this type of formalized collaboration — led by industry partners with milestone deliverables to achieve — forces structure on the different partners. This coordination becomes increasingly important as industry, vendors and regulators proceed further into the uncharted territory of increasingly novel biologics and as they encounter new issues to be solved.
“They all need to move forward together to develop approaches. As the biomanufacturers develop new concepts, the vendors need to supply new technologies to help them, and the regulatory agency must come up to speed to accept these new approaches,” says Phillips. “If one of these moves forward without the other two, a novel solution will never be implemented.”
Tapping the power of the M Lab™ Collaboration Centers
MilliporeSigma’s M Lab™ Collaboration Centers play an active role in this network because they act as testing grounds for new technologies. Located in North America, Europe, South America and Asia, the nine M Lab™ Collaboration Centers offer a non-GMP (good manufacturing practice) environment where customers can take a deeper dive into next-generation bioprocessing technologies through practical, hands-on troubleshooting and experimentation.
“It is much easier, faster and in the end cheaper to work with the experts at the M Lab™ Collaboration Centers to test solutions and new technologies,” says Hribar. He explains that collaborators can take advantage of the technical experts and bioprocessing equipment that the centers provide. “You can collaborate with the team to find solutions you didn’t think of before and evaluate next-generation processing-enabling technologies,” he adds.
The M Lab™ Collaboration Centers also generate opportunities for mutual experiential learning and high-level exchange of expertise. For example, a drug company developing a new molecule for medicines can gain additional perspective.
“We as vendors have insights because we work with many different molecules,” says Phillips. “We bring strengths that our customers don’t have; they bring strengths that we don’t have. Most of the time, customers don’t have the facilities to extensively test new technologies internally because they are too time-constrained with their existing processes. In the end, what convinces a scientist or engineer is when they experience working with a technology and can arrive at a solution themselves.”
An indispensable alliance: the supplier-manufacturer-regulatory relationship
This triangular relationship between suppliers, regulatory agencies and biomanufacturers lessens risk in the technology development process by planning in advance for potential regulatory requirements while facilitating technology adoption and implementation. Given that regulatory approval can influence the success of a new approach, obtaining regulatory feedback early in the technology development process, as well as on an ongoing basis, is important to reduce risk.
Regulatory agencies also want to stay apprised of new developments in bioprocessing technologies. For example, this could be accomplished by a manufacturer presenting a scientific talk on a process-intensification technology and getting early feedback. According to Hribar, it is helpful to have regulatory discussions early in the development cycle, particularly when changing processes. “If you have a technology that offers better quality for a lower price, it is good to engage with regulatory agencies to gain their acceptance before implementation,” he says.
Working better together for the future
Taking a collaborative approach to next-generation bioprocessing can expedite R&D, reduce the cost of biologics and increase access to essential medicines. It can make a significant impact on the ability to bring therapies to market and deliver them to patients. “From our side, it enables us to tailor solutions to the needs of biomanufacturers,” says Phillips.
The nextBioPharmDSP collaborative project will enable Novartis to significantly shorten the development cycle for the process of manufacturing and launching a biotherapeutic, according to Hribar. “Collaboration between these organizations is really beneficial because it brings better results and overall faster progress,” he says.
External Engagement: membership in industry associations & consortia
MilliporeSigma ’s relationship with the biopharmaceutical industry includes actively participating in consortia such as the Horizon2020 Initiative, as well as industry associations such as NIIMBL or BPOG.
Horizon 2020 is the biggest EU Research and Innovation program ever with nearly €80 billion of funding available over 7 years (2014 to 2020) – in addition to the private investment that this money will attract. It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market.
In the U.S., the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a framework of 79 organizations from 17 states, develops innovative manufacturing technologies and advances collaborations with experts across industry, academia and government.