There has been too little progress toward developing the next generation of biopharma supply chain research and R&D infrastructure for emerging therapies in the United States.

Conversely, there has been rapid innovation in developing next-generation vaccines and biologic therapies in recent years, notably including those for COVID-19. Success in this space has however shed light on the shortcomings of the biopharma supply infrastructure – throughout the pandemic, inadequacies in raw material supply and quality, manufacturing capacity and scaling, logistics and product distribution and workforce expertise and availability created a perfect storm of failures in healthcare delivery.

Addressing the challenge

“Without a robust, established, national R&D and product development infrastructure for biomanufacturing and biologics supply chains, the United States will continue to fall behind in its ability to scale emerging therapies and translate them from the laboratory to clinical and market applications.”

This is one of the core discussions of the whitepaper ‘Research Infrastructure Needs to Support U.S. Leadership in Biomanufacturing’ published by the Georgia Institute of Technology (Georgia Tech). The paper is based on insights gathered at a research engineering conference, “Planning the Infrastructural Needs to Meet National Research Demand and Support the United States’
Leadership in Biomanufacturing”, which was backed with funding by the National Science Foundation (NSF).

For their part, the NSF has recognized the infrastructure challenge highlighted by the pandemic and has made a several investments into research on biomanufacturing and led on initiatives including funding the conference.

Through a series of workshops, the conference gathered input from multidisciplinary stakeholders, including Genezen’s Chief Scientific Officer Pratima Cherukuri. The participants offered insight into the requirements of building mid-size research infrastructure that would create a national hub and tools and technology warehouse for the biologics manufacturing and biopharma supply chain of emerging therapies and vaccines.

Areas of biomanufacturing infrastructure need

The workshop discussions that took place identified 4 essential areas where biomanufacturing process infrastructure is currently lacking, and the transformative infrastructure needed to enable scalable, cost-effective, rapidly deployable, and adaptive biomanufacturing for the future.

Previewing a whitepaper produced by Georgia Tech and NSF following the conference, they provided the four pillars as follows:

Facilities and Equipment

• Pilot-scale manufacturing facilities that allow rapid translation of lab-scale discoveries to Phase 1 and Phase 2 trials
• Shared centers designed for companies to participate in academia-industry or public-private partnerships for product development and manufacturing
• Consistent and secure data infrastructure and data standards
• Dedicated computing infrastructure/access (e.g., via cloud architecture or edge computing) combined with high-performance computing resources and security capabilities
• Analytical/quality control (QC) lab infrastructure located close to production facilities
• Development of improved cell lines for vector production
• Automated technology to support the establishment of highly integrated, distributed production with interoperable equipment

Systems and Tools

• Flexible automation technologies and in-line monitoring tools to support research in new, improved, or disruptive manufacturing technologies for cells, vaccines, and viruses at scale (or within a system allowing for scaling)
• Internet-of-things (IoT) for biomanufacturing
• Regulatory consultants to assist small-to-mid-sized companies and academic developers in FDA and other regulatory filings
• Design of experiments (DOE) software and multiplexed small-scale bioreactors for rapid process development
• GMP compliance support for all systems, tools, and materials
• Intellectual property (IP) guidelines/protocols
• Support for clinical trials with access to clinical trial sites, and infrastructure for study conduct
• Edge computing to accommodate disparate locations
• Development and use of techniques and tools to build biomanufacturing threat models, secure systems, security testing, and share cyber incidents

Education and Workforce

• Convergent knowledge and expertise base for the emerging and existing workforce
• Integrated educational and training modules to support future workforce requirements, including regulatory compliance
• Enabling cross-industry collaborations and emergency response
• Education programs to train tomorrow’s data management experts

Supply Chain and Distribution

• Inventory and stable supply of raw materials, including tracking and certification
• Storage facilities and product stability for biomanufacturing supply chains
• Data infrastructure and logistical support for supply-chain planning

Overarching needs for the biopharma industry

While there is obviously plenty of nuance, there are several threads that run throughout these pillars. At the infrastructure level, data integration, analytics, and security are needed to create robust, reliable material supply chains. At the service level, expertise in managing regulatory requirements, de-risking biologics development and scale-up and creating biomanufacturing efficiencies will be fundamental to success.

To help meet these needs, Genezen is investing in new infrastructure across early-phase process development, viral vector production and analytical testing services, as part of a multiphase master plan for a 75,000+ square foot cGMP-compliant Lentiviral vector production facility.