Government/Industry/Academia Collaborative Efforts to De-Risk and Accelerate Manufacturing Innovation Draw Strength from Pandemic Learnings

The US government is continuing to strengthen its collaborative efforts with industry and academia to de-risk and accelerate manufacturing innovation, as the learnings from the pandemic are further digested.

The pandemic experience has thrown an intense spotlight on where the barriers and the opportunities lie – and the high stakes involved – in bringing advanced technology more fully to bear in pharmaceutical manufacturing.

In turn, it has become increasingly clear that stakeholder communication and collaboration at both the domestic and international level is critical to the advancement of the knowledge sharing, platforms, standards, workforce training, and regulatory processes needed to propel innovation forward.

Among the US organizations at the forefront of these collaborative efforts are the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and its companion institutes in the Manufacturing USA network – established in the wake of the Revitalize American Manufacturing and Innovation (RAMI) Act passed by the US Congress in late 2014.

In response to the advanced manufacturing offshoring from the US since around 2000, the act provided funding to support more collaboration between industry, government, and academia in helping the US’s strong technology R&D cross the commercial product manufacturing threshold.

Further significant boosts to the pharma manufacturing innovation efforts have come from the American Pandemic Preparedness Plan, released by the White House’s Office of Science and Technology Policy (OSTP) in September 2021, and the CHIPS and Science Act, signed by President Biden in August 2022.

The five-part IPQ story provides a wealth of insights from key leaders and policy makers on the issues at play and how government, industry, and academia are collaborating through NIIMBL and other organizations to address them in the US and internationally.

PART I: NIIMBL and Its “Going First Together” Mantra

The first part of the story provides an update on NIIMBL’s efforts to accelerate biomanufacturing innovation and develop the needed supporting standards and workforce skills. In focus is a keynote presentation by NIIMBL Director Kelvin Lee at the 2022 PDA Annual Meeting in which he explored how NIIMBL brings together government, industry, and academia to collaborate on de-risking biomanufacturing innovation on a pre-competitive basis. He reviewed the strategic program/workstream approach the institute is taking to tackle overarching issues – focusing attention on the process intensification program, in particular. Also highlighted was NIIMBL’s  200-page case study “N-mAb,” supporting the development and adoption of continuous bioprocesses for monoclonal antibodies.

PART II: US Manufacturing Innovation Leaders Weigh In

The second part moves to the opening plenary session of the 2022 NIIMBL annual meeting, during which a panel of US leaders from organizations involved in supporting biomanufacturing innovation provided their insights on the issues involved and the role that NIIMBL and their respective organizations are playing. Presenting were: ● US Senator Chris Coons ● NIST Director Laurie Locascio ● NIIMBL’s Lee ● White House OSTP Senior Advisor Matthew Hepburn ● CBER Director Peter Marks ● BIO CEO Michelle McMurry-Heath, and ● FDA Principal Deputy Commissioner Janet Woodcock. They reflected on how the pandemic had heightened the importance of the pharma manufacturing innovation dialogue and stakeholder collaboration.

PART III: The Importance of Process and Facility Innovation in Global Health

Part III of the story moves forward to the February 2023 ISPE Facilities of the Future (FOF) Conference where OSTP’s Hepburn provided more insights on the current US government efforts to work with industry on pharmaceutical manufacturing innovation and preparing for future pandemics and other outbreaks. Under discussion by Hepburn were: ● why manufacturing innovation matters and the current OSTP support approach ● the role of public-private partnerships ● pivoting ability and global vaccine delivery ● specific programs, including Manufacturing USA and BARDA Ventures, and ● the need for flexibility/scalability and international harmonization.

Also reviewed is the discussion at an FOF dinner panel of organization thought leaders on whether the global convergence of regulatory processes that took place during the pandemic could continue and the top wishes for improving the pharmaceutical industry by 2030.

A third component of this part of the story is a review of the initiative launched by ISPE in mid-February on “Enabling Global Pharma Innovation.” Included is ISPE’s description of: ● the program goals ● the problem motivating the initiative ● regulatory activities to promote pharmaceutical manufacturing innovation ● learnings from the COVID pandemic ● industry’s innovation efforts, and ● how the program is being organized.

PART IV: Charting the Advanced Therapy CMC Pathways

Following the substantial contribution made by A-mAb and A-Vax in bringing a better understanding of how to implement QbD-based principals and CMC best practices into the development of complex biologicals, NIIMBL has been strongly backing similarly informative case studies for continuous manufacturing of mAbs (“N-mAb”) and for cell and gene therapies (“A-Cell” and “A-Gene”). The latter projects, also resulting in 200-plus page documents, were carried out under the direction of the Alliance for Regenerative Medicine (ARM) with NIIMBL support. IPQ also explains the role for NIST-mAb and NIST-CHO  as reference materials supporting and advancing the biotherapeutic development process.

Covered in this part of the story are recent webinars NIIMBL has run addressing its initiatives on big data, process intensification, viral vector manufacturing and analytics, and biomanufacturing readiness levels.

PART V: CBER’s Marks On Taking CGT Development to the Next Level

As the guest speaker at a “Maryland BioNetworking Summit” cosponsored by NIST and the University of Maryland held in February 2023, CBER’s Marks began by reviewing the current state of cell and gene therapy R&D and product approvals. He then discussed some of the barriers to further CGT development and how they can be overcome – focusing on the role that increased global regulatory collaboration needs to play in particular. He concluded his talk by highlighting some of CBER’s current CGT innovation support initiatives. During the Q&A that followed, Marks addressed: ● approving and paying for rare disease therapies ● nonviral vectors ● Phase 0 trials in gene therapy ● standardizing lab processes ● long-term follow-up for gene therapies, and ● price control.

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