Testimony of Alina Alexeenko-Peroulis, PhD — Co-Founder and President, LyoWave, Inc.; Purdue University

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Written testimony of Alina Alexeenko-Peroulis, PhD, co-founder and president of LyoWave, Inc. and a Purdue University professor, for the U.S. Senate Committee on Small Business & Entrepreneurship hearing on the role of small businesses in America's bioeconomy, dated April 7, 2026. The testimony describes lyophilization, or aseptic freeze-drying, and recounts its use in a blood plasma program begun in spring 1941. It describes the Advanced Lyophilization Technology Consortium (LyoHUB) established in 2015, a 2021 NIIMBL funding award, a series seed round in May 2024 and an SBIR Phase 1 award that supported the LyoWave TurboDry microwave lyophilization system. It closes with three recommendations: strengthen SBIR/STTR, create incentives for adoption of advanced manufacturing technologies, and build regional shared-use facilities.

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                            Testimony of Alina Alexeenko-Peroulis, PhD

        Co-Founder and President, LyoWave, Inc.; Reilly Professor, Aeronautics and
     Astronautics and Chemical Engineering, Purdue University; Founding Co-Director,
                Advanced Lyophilization Technology Consortium (LyoHUB)

          Hearing on “Fueling Innovation: The Role of Small Businesses in America’s
                                       Bioeconomy”
               U.S. Senate Committee on Small Business & Entrepreneurship

                                               April 7, 2026


Senator Young and Distinguished Guests:

Thank you for the opportunity to testify on the role of small businesses in America’s
bioeconomy.

I am honored to share my perspective as a co-founder of LyoWave, Inc., an Indiana-based
startup company launched in 2023 based on inventions at Purdue University. LyoWave’s
mission is to overcome key bottlenecks of producing biotech-based products, focusing
first on lyophilization. Lyophilization, also referred to as aseptic freeze-drying, is a critical
manufacturing operation that allows stabilization of complex biologic molecules so they
can be processed, stored and delivered to patients and users. Lyophilization, although a
decades-old technique, is a workhorse of modern biotechnology. We are not developing a
faster horse but replacing it altogether with a multi-terrain vehicle that can move novel and
legacy biotech products to market safely, at speed and scale.

The past is prologue to the future, and the history of lyophilization underpins the origin of
American leadership in biotechnology in the 20th century and the urgency we now have to
recapture it. Eighty-five years ago, in spring 1941, prior to America’s entry into World War II,
the U.S. Army and Navy deployed a massive industrial program to supply blood plasma to
save wounded soldiers in the battlefields in Europe. The program used the technology we
now call lyophilization in drying blood plasma in sterile conditions. This technology was
invented at an American university, UPenn, in collaboration with Philadelphia-based
Sharpe & Dohme Co., which later merged with the pharmaceutical giant Merck. The Army
Medical Procurement Agency issued purchasing orders on behalf of the Army and Navy and
supplied equipment and manufacturing instructions for 11 firms across the country for
processing blood plasma collected by the Red Cross.1 More than 6 million Americans
donated blood to provide powdered “life for the wounded.” Maj. Gen. Normal Kirk, surgeon
general of the U.S. Army, referred to freeze-dried blood plasma as “the foremost lifesaver”



1
    https://achh.army.mil/history/book-wwii-blood-chapter11


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of injured U.S. soldiers in WWII and one of the critical medical technologies that
contributed to the Allies’ victory.

In less than a year, a whole new industry was established with processing equipment and
standards supplied by the Army and Navy, representing an unprecedented win of a public-
private partnership. Beyond the immediate battlefield treatment of wounded soldiers, the
dry blood plasma program set the stage for the major medical breakthroughs of peacetime,
to stabilize and make possible mass manufacture of the first antibiotic, penicillin2. With the
established national network of manufacturers and after Europe’s capacities were critically
disrupted, the U.S. became the main provider of life-saving medicines for much of the
world. The fermentation plants and human expertise developed for penicillin and other
early antibiotics became the critical enabling capability for manufacturing the
biotechnology-based medical treatments pioneered in America in the 1970s.

Now lyophilization is used to manufacture recombinant protein drugs including those for
treatment of heart attacks and autoimmune diseases, antibody-drug conjugates for newest
targeted cancer therapies, vaccines and viral vector-based genetic medicines, and many
diagnostic reagents. Additionally, most injectable antibiotics on the essential medicines
list3 are manufactured in a lyophilized form. However, lyophilization also is a very long and
costly process requiring space-like vacuum conditions. In 2015, through the NIST
Advanced Manufacturing Technology Consortia (AMTech) program4, Purdue University with
key industry and academic partners established the Advanced Lyophilization Technology
Consortium (LyoHUB) to develop a technology roadmap5 to identify critical challenges and
strategies for innovation. The need for deep disruptive technological changes in
lyophilization became clear, and one identified opportunity was to use modern high-power
radio frequency semiconductor technologies instead of the approaches developed
decades ago for the industrialization of dry blood plasma production.

Through initial internal research at Purdue’s College of Engineering, we developed a
prototype of a high-frequency microwave setup with power sources for satellite
communication to augment the traditional lyophilization equipment, accelerating its
throughput by multiple times. A competitive funding award in 2021 from The National
Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)6 allowed us to
partner with Merck and IMA Life to test the new microwave-assisted lyophilization on real
biologics, otherwise not available for university researchers, and further advance the
prototype’s biomanufacturing readiness. These were the first real molecules and cells as
passengers for the vehicle rather than the horse of lyophilization. Through the NIIMBL-
organized “Dancing with Venture” events, I learned about VC funding routes for taking

2
  E. W. Flosdorf, Freeze-Drying: Drying by Sublimation. Reinhold Pub. Corp., New York, 1949.
https://archive.org/details/freezedryingdryi0000earl/page/n5/mode/2up
3
  https://www.fda.gov/media/143406/download?attachment
4
  https://www.nist.gov/oam/programs/advanced-manufacturing-technology-consortia-amtech-program
5
  https://pharmahub.org/groups/lyo/lyohub_roadmapping
6
  https://www.niimbl.org/projects/tunable-rf-microwave-drying-of-biologics/


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biomanufacturing innovations to market. To me, as a trained applied mathematician and
engineer, that frankly was a totally new and somewhat scary domain.

Biotech manufacturing innovation is talent- and capital-intensive. That’s why sustained
innovation networks such as those enabled by university-industry centers like LyoHUB,
national manufacturing institutes like NIIMBL and other public-private partnerships are
critical to develop teams, demos, data and IP that enable transitioning inventions to market
through company creation. Helped by Purdue’s resources for entrepreneurship training
(e.g., regional I-Corps and Firestarter programs) and the amazing alumni and advisor
network, our co-founder team attracted perfect VC investors for our series seed round in
May 2024. This allowed us to license IP from Purdue, lease space, and have co-founders Dr.
Drew Strongrich and Dr. Ahmad Darwish start their jobs at LyoWave to “make, market and
sell” our race car replacement of the workhorse of biotech. With the SBIR Phase 1 award
last year, we were able to add critical mechanical and software engineering expertise to the
team and deliver the first LyoWave TurboDry microwave lyophilization system, made in
Indiana, with installation at a customer site on the U.S. East Coast. Unlike the university-
developed prototype that would hardly fit into a minivan, the highly integrated system with
custom-built electronics by LyoWave fits into a carry-on bag. It can be installed in less than
an hour on existing R&D-scale lyophilization equipment. We now are in the steep climb to
transition it to CGMP-compliant large-scale aseptic production systems.

Based on the experience I have shared, I oeer these recommendations to bolster
biomanufacturing innovations by early-stage technology innovator companies:
   • Continue and strengthen established programs like SBIR/STTR and further motivate
      small-business participation in programs on reshoring end-to-end manufacturing of
      critical bio/pharma products (e.g., by ASPR).
   • Establish incentives for adoption of advanced technologies by biotech
      manufacturers to oeset regulatory acceptance costs. The Advanced Manufacturing
      Technology Designation Program rolled out by the FDA recently is a good first step.
   • Create a network of regional shared-use facilities for test-driving and de-risking new
      biomanufacturing technologies. Such facilities with GMP-relevant manufacturing
      equipment would become a speedway for innovation in biomanufacturing.

Thank you for the opportunity to provide my perspective. I look forward to answering your
questions.




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