Dr Kevin Robinson held a virtual roundtable with representatives from a number of top-tier contract (development and) manufacturing organisations (CMOs/CDMOs), including Pfizer CentreOne, Samsung Biologics, MedPharm, Metrics Contract Services, Vibalogics and Sterling Pharma Solutions, to discuss the pressing issues in the pharmaceutical outsourcing sector
In the final part of the discussion, and circling back to the key topic of current issues facing CMOs and CDMOs, I ask the panellists what they think the contract manufacturing industry and its development partners should be doing now.
“The pharma industry is increasingly seeing digital transformation across the board,” says James Choi, Senior VP, Chief Information and Marketing Officer, Head of Investor Relations, Samsung Biologics: “Innovative technologies are becoming more important and adopting cutting-edge technologies that help to expedite the drug development and manufacturing process can really make the difference to customers.”
“At Samsung Biologics, we continue to leverage digitalisation to optimise the client experience. We are always looking for ways to implement new technologies to enhance and improve our processes,” he comments, adding: “Our digitalised enterprise platforms will be implemented in Plant 4 and allow our clients live (24/7) access to quality information related to their respective campaigns."
"Regulatory authorities will also have full remote access to documentation, including quality records during inspections and audits. Throughout the current pandemic, we have already facilitated a number of virtual tours for clients, specifically for due diligence, as well as regulatory authorities doing inspections."
"Most recently, the US FDA did an online inspection of Plant 3 using our Live Virtual Tour solution, and this was instrumental for our client to be able to accelerate the global supply of its COVID-19 antibody therapies.”
“In addition, we have opened our Plant 4 Virtual Showroom to provide key features and real-time construction updates of our newest facility for current and potential clients in need of additional capacity to manufacture their future pipelines."
"As we are facing a time of significant changes to the market dynamics, biopharma companies, including CDMOs, should be ready to embrace this digital transformation to ensure they can withstand any fluctuations or obstacles as the industry continues to grow.”
In the same vein, MedPharm’s Vice President of Business Development, Lynn Allen, observes that “the world continues to throw new challenges at the pharma industry and, as such, CDMOs need to adapt to the changing needs of drug manufacturers."
"COVID has taught pharma to challenge itself and achieve what was previously thought to be impossible … and the CDMOs that continue to innovate at the pace of pharma are the companies that continue to grow in the field.”
“As the pharmaceutical industry continues to entrust development and manufacturing activities to the CDMO industry, service providers become an extension of their sponsors. CDMOs need to continue to adapt processes to balance flexibility and dependability. By closely collaborating with sponsors and understanding both market needs and long-term forecasts, CDMOs can plan for new investments in capacity and systems that can support growth.”
Tom Wilson, Contract Manufacturing Lead at Pfizer CentreOne, notes: “The regulatory landscape is dramatically evolving, with regulators keen to bring essential medicines to market."
"There are new things happening as a result of the COVID-19 pandemic. Hence, sponsor companies, CMOs and CDMOs need to ensure that their Regulatory Affairs teams are talking to each other. They need to share their experiences and discuss regulatory expectations going forward.”
“CDMOs have also started to accommodate a virtual workplace that has generated real innovation. Working together in challenging circumstances will continue to be a game-changer as virtual working allows us to collaborate more readily in real-time. Strong video capabilities are critical to bringing people together faster and also allows partners to save time by eliminating the need to travel to visit sites.”
“CDMOs should be investing in new manufacturing technology,” suggests James Rogers, Head of Manufacturing and Supply at Sterling Pharma Solutions, “together with digitisation and machine learning strategies to ensure they are well prepared to meet future customer and product demands."
"Project timescales are increasingly becoming the most important factor in the drug development process. By harnessing cutting-edge manufacturing technology, CDMOs can ensure that they are well placed to minimise manufacturing costs while also enhancing quality and reducing delivery times.”
“Enhanced collaborations between CDMOs, technology companies and academic institutions will also allow the industry to develop and deliver cost-effective, flexible and efficient services to their customers."
"Production flexibility is something that Sterling has been particularly successful at achieving. Our in-house engineering team can design and build custom plant and develop solutions to ensure that our production capacity offers maximum benefit to customers."
"We have invested approximately £35 million during the last 4 years throughout our facilities, which not only provides additional capacity, but also improves our sustainability credentials.”
Stefan Beyer, President and Managing Director, Vibalogics, recommends that CDMOs should take care of their forward, intermediate and post-production partners throughout their supply chain.
“This includes suppliers of consumables, packaging materials and external testing capacity. They should be working with them to optimise planning procedures to manage long lead times. They should also continue to establish and nurture true service partnerships with their clients rather than adopt a contract giver-contract acceptor mentality, building a more in-depth relationship to add value to their clients.”
“In addition, to ensure CDMOs continue to be able to offer the flexible capacity that biopharma drug developers need, it’s crucial that CDMOs take steps to maximize their capacity now by building and expanding drug substance and drug product lines."
"One option that has been taken up by viral vector CDMOs is to increase their bioreactor capacity. It’s now possible to source single use (SU) bioreactors at volumes of up to 5000 L, which helps to increase the size of individual batches. Implementing high-cell-density perfusion USP processes can also boost efficiency.”
He continues: “Particularly for the viral vector sector, screening for high-producer cell clones, utilising technologies to achieve high cell densities and perfusion cultures, and enhancing virus recovery can all help to increase capacity. And, in terms of process optimisation, implementing SU manufacturing solutions can minimise downtime compared with maintaining and cleaning standard reusable equipment.”
“The development of new technologies to minimise vaccine dose size can also play a key role, by allowing formulations to stretch further, and multidose vial filling helps to reduce packaging needs and streamline administration."
"Finally, taking steps to build a pool of expertise and know-how through recruitment and by nurturing of the next generation of biopharma professionals can help us to identify exciting new solutions that will deliver a greater number of new projects on time and in full.”
Adding the last word, Britton Jimenez, VP Business Development, Metrics Contract Services, concludes: “As our industry continues to evolve, our mindsets and processes must do the same. I believe our mindsets have changed dramatically, but the industry’s processes and the way we develop products have not."
"Many organisations have continued to do the same thing the same way … and we have accepted it. CDMOs need to ask questions about their current process, and if they aren’t adequate anymore, explore which new processes make sense and what investments need to be made. Innovators continue to evolve based on market needs and demands, and their partners need to follow suit.”
“Another key issue is communicating early and often. Sponsors often present their needs much too late in the process for service partners to be able to get creative and plan accordingly. Even if the information is limited and likely to change because of the dynamics of drug development, early communication allows for development partners to start thinking about how they might handle the project to ensure they build the best plans for success.”