Biomanufacturing

Form Bio Applauds The White House’s New Goals and Priorities Promoting Growth of Domestic Cell and Gene Therapy Biomanufacturing

We support the commitment of the Biden-Harris Administration to address global issues through biomanufacturing innovation. Learn more.

Andrew Busey & Kent Wakeford

Andrew Busey & Kent Wakeford

March 27, 2023

Form Bio Applauds The White House’s New Goals and Priorities Promoting Growth of Domestic Cell and Gene Therapy Biomanufacturing

The impact of biotechnology and biomanufacturing on daily life is immense, covering everything from medicine to fuel to plastic alternatives. However, the traditional dependence on foreign materials and biomanufacturing threatens access to materials, biosafety and biosecurity.  In response, President Biden launched an Executive Order in September of 2022, a National Biotechnology and Biomanufacturing Initiative, to promote domestic biomanufacturing1.  Recently, the Biden-Harris Administration announced2 the release of a report by the Office of Science and Technology Policy3 outlining the plan to achieve this goal, including strategic investments in biomanufacturing capacity, expanding market opportunities for bio-based products, prioritizing biotechnology R&D to drive discovery and expanding the use of more sustainable bio-based materials to combat climate change. 

Particular emphasis was placed on laying the supportive groundwork through increased training of a diverse and skilled workforce, clarification of the regulatory processes for bio-based goods, and, importantly, improving access to and security of high-quality biological data sets.

As outlined in the report3, the bold goals for domestic biomanufacturing include:

In 20 years:

  • Bring down production costs for cell-based therapies by tenfold. 
  • Produce at least 30% of the U.S. chemical demand via biomanufacturing pathways.
  • Produce 90% of plastics from bio-based polymers.

In 5 years:

  • Sequence the genomes of one million microbial species and uncover the function of 80% of newly discovered genes. 

Form Bio’s Partnership With the Cell and Gene Therapy Industry to Reach These Bold Goals

Form Bio is leveraging state-of-the-art artificial intelligence and bioinformatics expertise to help drive and reach the ambitious set of goals outlined in this new report3. Together, we and our partners in the cell and gene therapy industry, celebrate this newly forged path toward a more robust bioeconomy. This carefully coordinated effort by a federal agency signals that biotechnology and biomanufacturing are the industries of tomorrow.  However, the full potential of biomanufacturing applications can only be unlocked with continued investments in advancements in science, engineering, and computing. Through this initiative, Form Bio is confident our mission will open up new pathways for innovation at breakneck speed in the ever-changing domain of biomanufacturing technologies.

Furthermore, the initiative affirms our thesis: The world needs to bring together scientists, engineers, and computational power at a scale to unlock the benefits of biotechnology. Closing the gap between biological data and discovery is core to our mission and will rapidly drive the leading edge of cell and gene therapy biomanufacturing forward4

The initiatives and investments outlined in this new report3 set a plan in motion to solve some of the toughest challenges in biomanufacturing, thus lowering the barrier to bring innovative cell and gene therapy technologies to market.  More specifically, the report outlines five themes to further human health and includes the following:

  • accessible health monitoring
  • precision multi-omic medicine
  • biomanufacturing of cell-based therapies 
  • artificial intelligence-driven bioproduction of therapeutics 
  • advanced techniques in gene editing

We are focused on simplifying computational work for biologists in academia, and biotechnology with an emphasis on improving the manufacturability of cell and gene therapies using our state-of-art artificial intelligence and bioinformatic platform. By working together with our private and public partners, we will accelerate time to market and optimize the production of these revolutionary cell and gene therapeutics, thereby making a significant contribution to the domestic biomanufacturing initiative.

Authors Andrew Busey and Kent Wakeford are Co-CEOs of Form Bio. 

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References

  1. Fact Sheet: President Biden to Launch a National Biotechnology and Biomanufacturing Initiative. The White House website. Published September 12, 2022. Accessed March 22, 2023.
  2. Fact Sheet: Biden-Harris Administration Announces New Bold Goals and Priorities to Advance American Biotechnology and Biomanufacturing. Published and Accessed March 22, 2023.
  3. Bold Goals for US Biotechnology and Biomanufacturing. Harnessing Research and Development to Further Societal Goals. Compiled by The White House Office of Science and Technology Policy. Published and Accessed March 22, 2023. 
  4. Nipko, J. Developing Machine Learning Powered Solutions for Cell and Gene Therapy Candidate Validation. Form Bio Resource Center. Published November 2022. Accessed February 8, 2023.

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