Bio Usawa and Pacific Environmental Technologies Announce Landmark Partnership to Develop and Deploy Modular cGMP Biomanufacturing Units for Africa

A pioneering monoclonal antibody facility for Rwanda marks a pivotal step toward scalable, locally driven production of life-saving biologics across the African continent

/EIN News/ -- SAN FRANCISCO and KIGALI, Rwanda, May 22, 2025 (GLOBE NEWSWIRE) -- Bio Usawa, Inc., a biopharmaceutical company based in San Francisco, Kigali, and Nairobi, committed to expanding access to life-saving biologics in Africa and underserved regions, today announced an agreement with Pacific Environmental Technologies, Inc., a global leader in cleanroom facility design and construction, to design, build, and deploy state-of-the-art, self-contained modular biomanufacturing units.

The units will comply fully with regulatory requirements of the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization. Construction will commence in May 2025, with the first module scheduled for operational readiness in Kigali by the end of Q4 2025.

The modules are engineered for rapid deployment and tailored for resource-limited environments. They will enable local production of monoclonal antibody-based therapies, focused on those for diabetic macular edema, with plans for HER2-positive breast and other cancers, non-Hodgkin’s lymphoma, rheumatoid arthritis, and other serious unmet medical needs.

“In a world where state-of-the-art, life-saving drugs for cancer and infectious diseases are not available to or affordable for a large majority of the world’s population, this manufacturing module will allow us to rapidly meet the needs of these patients. Pacific Environmental Technologies is an experienced, well-regarded manufacturer of sophisticated manufacturing facilities, and we are delighted to partner with them,” said Dr. Menghis Bairu, Co-founder, President and CEO of Bio Usawa, Inc. “This is only the beginning,” added Dr. Bairu. “We are building for scale, for resilience, and for the future of global health access, starting here in Africa.”

“As a leading manufacturer of custom turnkey cleanroom and laboratory facilities worldwide, our containerized, mobile biopharmaceutical manufacturing facilities are ideal for deployment in Rwanda, Africa,” said Jon Gow, President of Pacific Environmental Technologies, Inc. “This agreement will help Bio Usawa realize its vision of bringing life-saving biologics to underserved areas.”

The burden of noncommunicable diseases such as cancer and diabetes is rising rapidly across Africa. Breast cancer is now the most commonly diagnosed cancer among women, with HER2-positive subtypes accounting for approximately 23 percent of cases, according to a 2021 study published in JCO Global Oncology. Non-Hodgkin’s lymphoma also represents a major share of hematologic cancers, comprising around 66% of lymphoma cases on the continent, as reported in a 2024 systematic review in Scientific Reports. While mAb therapies have proven highly effective for these diseases, access remains limited due to high international prices and limited local biomanufacturing capacity, leaving millions untreated.

Diabetes presents an equally urgent challenge. The International Diabetes Federation estimates that 24.6 million people in Africa were living with diabetes in 2024, with that number projected to more than double to 59.5 million by 2050. A 2024 study in Scientific Reports found that diabetic retinopathy affects roughly one in three individuals with diabetes, with one in three progressing to DME—a leading cause of preventable vision loss. Despite urgent demand, patients across the continent continue to face significant barriers to accessing affordable, life-saving biologics.

Bio Usawa is led by a seasoned team of biopharmaceutical industry professionals and pioneers with decades of diverse experience in biologics R&D, clinical development, regulatory strategy, manufacturing, and commercialization, bringing deep global expertise to a bold regional vision. The company’s leadership has helped bring multiple blockbuster biologics to market, and is now leveraging that experience to drive down costs and build sustainable, locally anchored production models.

This initiative builds on alignment regarding facility design with the Rwandan FDA, and a series of agreements signed or under review with key government stakeholders in Rwanda, Kenya and Senegal, which coincide with the Continent’s growing leadership in health innovation and next-generation biomanufacturing. With operations set to launch in both Rwanda and Kenya, Bio Usawa is strategically positioned to bridge infrastructure and supply chain gaps that have long limited biopharmaceutical self-sufficiency and broad access to advanced therapies across the Continent.

About Bio Usawa
Bio Usawa has a singular mission: to manufacture high-quality, effective, and affordable biosimilars for patients in Africa. It is applying 100+ years of combined experience in the industry in partnership with governments, agencies, educators and health professionals to make transformative biomedicines in Africa, by Africans, for Africans and beyond.

About Pacific Environmental Technologies Inc.
Pacific Environmental Technologies, Inc. is a leading full-service cleanroom and laboratory construction company that is highly recognized for its technical expertise and service-minded professionals. With more than three decades of engineering excellence, PETI leverages its comprehensive in-house capabilities to serve clients worldwide across the biopharmaceutical, biomedical, semiconductor, aerospace, and related industries.

Contact:
Daniel Levine
Levine Media Group
510-280-5405
danny@levinemediagroup.com