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Bionova Opens Fremont Process Development and Pilot Plant

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Bionova Scientific, an Asahi Kasei company (AHKSY), has opened a new 55,000 sq. ft. process development and pilot plant in Fremont, California. The facility aims to enhance the company's capabilities in advancing early-stage biologics to first-in-human trials and expand manufacturing capacity.

The opening ceremony was attended by approximately 150 industry and community leaders, including Fremont Mayor Raj Salwan and representatives from various government offices. Located in the Biotech Bay region, which generates over $142 billion in economic activity and 328,000 jobs, the facility strategically positions Bionova to serve local biotech innovators.

The new facility consolidates all pre-GMP activities under one roof, enabling seamless technology transfer and improved efficiency in process development. This expansion strengthens Bionova's role as a CDMO partner for both early-stage biopharmaceutical innovators and larger biopharma customers.

Bionova Scientific, una società di Asahi Kasei (AHKSY), ha inaugurato un nuovo impianto di sviluppo processi e pilota di 55.000 piedi quadrati a Fremont, California. La struttura mira a potenziare le capacità dell'azienda nel portare biologici in fase iniziale a prove cliniche di prima linea e ad ampliare la capacità produttiva.

Alla cerimonia di apertura hanno partecipato circa 150 leader del settore e della comunità, tra cui il sindaco di Fremont Raj Salwan e rappresentanti di vari uffici governativi. Situata nella regione del Biotech Bay, che genera oltre 142 miliardi di dollari in attività economica e 328.000 posti di lavoro, la struttura posiziona strategicamente Bionova per servire gli innovatori locali nel settore biotech.

Il nuovo impianto consolida tutte le attività pre-GMP sotto lo stesso tetto, consentendo un trasferimento tecnologico senza soluzione di continuità e un miglioramento dell'efficienza nello sviluppo dei processi. Questa espansione rafforza il ruolo di Bionova come partner CDMO sia per gli innovatori biopharmaceutical in fase iniziale che per i clienti biopharma di maggiori dimensioni.

Bionova Scientific, una empresa de Asahi Kasei (AHKSY), ha inaugurado una nueva planta de desarrollo de procesos y piloto de 55,000 pies cuadrados en Fremont, California. La instalación tiene como objetivo mejorar las capacidades de la empresa en el avance de biológicos en etapas tempranas a ensayos clínicos en humanos y expandir la capacidad de fabricación.

A la ceremonia de apertura asistieron aproximadamente 150 líderes de la industria y de la comunidad, incluidos el alcalde de Fremont, Raj Salwan, y representantes de diversas oficinas gubernamentales. Ubicada en la región de Biotech Bay, que genera más de 142 mil millones de dólares en actividad económica y 328,000 empleos, la instalación posiciona estratégicamente a Bionova para servir a los innovadores locales en biotecnología.

La nueva instalación consolida todas las actividades pre-GMP bajo un mismo techo, lo que permite una transferencia de tecnología sin problemas y una mayor eficiencia en el desarrollo de procesos. Esta expansión refuerza el papel de Bionova como socio CDMO tanto para innovadores biofarmacéuticos en etapas tempranas como para clientes biofarmacéuticos más grandes.

Bionova Scientific는 Asahi Kasei의 자회사(AHKSY)로, 프리몬트, 캘리포니아에 55,000 평방피트 규모의 공정 개발 및 파일럿 플랜트를 새로 열었습니다. 이 시설은 회사가 초기 단계의 생물 의약품을 인간 대상 시험으로 발전시키고 제조 용량을 확장하는 능력을 향상시키는 것을 목표로 하고 있습니다.

개관식에는 프리몬트 시장인 Raj Salwan과 다양한 정부 기관의 대표들을 포함하여 약 150명의 산업 및 지역 사회 리더들이 참석했습니다. Biotech Bay 지역에 위치한 이 시설은 1,420억 달러 이상의 경제 활동과 328,000개의 일자리를 창출하며, Bionova가 지역 생명공학 혁신가들에게 서비스를 제공할 수 있는 전략적 위치를 차지하고 있습니다.

새로운 시설은 모든 사전 GMP 활동을 하나의 지붕 아래 통합하여 원활한 기술 이전과 공정 개발의 효율성을 향상시킵니다. 이 확장은 초기 단계의 생물 의약품 혁신가와 대형 생물 제약 고객 모두를 위한 CDMO 파트너로서 Bionova의 역할을 강화합니다.

Bionova Scientific, une entreprise d'Asahi Kasei (AHKSY), a ouvert une nouvelle usine de développement de processus et pilote de 55 000 pieds carrés à Fremont, Californie. L'installation vise à améliorer les capacités de l'entreprise à faire avancer les biologiques en phase précoce vers des essais cliniques chez l'homme et à élargir la capacité de fabrication.

La cérémonie d'ouverture a été marquée par la présence d'environ 150 leaders de l'industrie et de la communauté, y compris le maire de Fremont, Raj Salwan, et des représentants de divers bureaux gouvernementaux. Située dans la région de Biotech Bay, qui génère plus de 142 milliards de dollars d'activité économique et 328 000 emplois, l'installation positionne stratégiquement Bionova pour servir les innovateurs locaux en biotechnologie.

La nouvelle installation regroupe toutes les activités pré-GMP sous un même toit, permettant un transfert de technologie fluide et une amélioration de l'efficacité dans le développement des processus. Cette expansion renforce le rôle de Bionova en tant que partenaire CDMO pour les innovateurs biopharmaceutiques en phase précoce ainsi que pour les clients biopharmaceutiques de plus grande taille.

Bionova Scientific, ein Unternehmen von Asahi Kasei (AHKSY), hat ein neues 55.000 Quadratfuß großes Prozessentwicklungs- und Pilotwerk in Fremont, Kalifornien eröffnet. Die Einrichtung zielt darauf ab, die Fähigkeiten des Unternehmens zu verbessern, frühe biopharmazeutische Produkte in klinische Studien zu bringen, und die Produktionskapazität zu erweitern.

Zur Eröffnungsfeier kamen etwa 150 Führungspersönlichkeiten aus der Industrie und der Gemeinschaft, darunter der Bürgermeister von Fremont, Raj Salwan, und Vertreter verschiedener Regierungsstellen. Die Einrichtung befindet sich in der Region Biotech Bay, die über 142 Milliarden Dollar an wirtschaftlicher Aktivität und 328.000 Arbeitsplätze generiert und positioniert Bionova strategisch, um lokale Biotech-Innovatoren zu bedienen.

Die neue Einrichtung fasst alle vor-GMP-Aktivitäten unter einem Dach zusammen, was einen nahtlosen Technologietransfer und eine verbesserte Effizienz in der Prozessentwicklung ermöglicht. Diese Expansion stärkt die Rolle von Bionova als CDMO-Partner für sowohl frühe biopharmazeutische Innovatoren als auch größere Biopharma-Kunden.

Positive
  • New 55,000 sq. ft. facility expands biologics development capabilities
  • Strategic location in major biotech hub worth $142B in economic activity
  • Enhanced operational efficiency through consolidated pre-GMP activities
  • Increased capacity to serve both early-stage and large biopharma clients
Negative
  • None.

FREMONT, Calif.--(BUSINESS WIRE)-- Bionova Scientific, an Asahi Kasei company and boutique commercial-scale biologics contract development and manufacturing organization (CDMO), has announced the opening of a new facility in Fremont, California. The 55,000 sq. ft. process development and pilot plant will significantly expand the company’s ability to advance early-stage biologics assets to first-in-human trials and facilitate the future expansion of its manufacturing capacity.

Bionova leadership team celebrates ribbon cutting at new Fremont, CA Process Development & Pilot Plant facility with community leaders. (Photo: Business Wire)

Bionova leadership team celebrates ribbon cutting at new Fremont, CA Process Development & Pilot Plant facility with community leaders. (Photo: Business Wire)

Bionova hosted a ribbon-cutting ceremony attended by approximately 150 industry and community leaders to mark the occasion. Darren Head, Chairman & President; Jesse McCool, Ph.D., Chief Scientific Officer; and James Glover II, Chief Operating Officer, were joined by The Honorable Raj Salwan, Mayor of the City of Fremont. Representatives were also in attendance from the Office of Congressman Ro Khanna and Congressman Eric Swallwell; the Office of State Senator Dr. Aisha Wahab; the Office of the Alameda County Assessor Phong La; and Cindy Bonior, CEO of the Fremont Chamber of Commerce.

“Many of our customers are early-stage biopharmaceutical innovators who need agile partners who can quickly provide process development and reliable manufacturing operations that are scaleable, without the need to tech transfer to another CDMO as their programs mature,” commented Darren Head, Chairman & President of Bionova. “This new facility enhances our capacity to serve early-stage clients while also providing overflow capacity for our larger biopharma customers.”

At the event, Fremont Mayor Raj Salwan commented, “Fremont has long been a leader in biopharmaceutical and medical device manufacturing. Being home to over 100 biomedical companies, Fremont has adopted the industry slogan of being the City where BioMed goes to scale. Having operated its entire existence in Fremont, Bionova is unique in being a 100% homegrown success story, and their growth has been remarkable. Fremont wholeheartedly congratulates Bionova on their new facility and expansion in our community and looks forward to our continued partnership for many years to come.”

Widely known as "Biotech Bay," the biopharma industry in the San Francisco Bay Area is considered one of the largest in the United States, generating more than $142 billion in economic activity and over 328,000 direct and indirect jobs. The region represents a substantial portion of U.S. biotech venture capital investment, positioning Bionova to help local innovators advance their assets to the clinic efficiently and cost-effectively.

“Bionova’s team of bioprocess experts has proven itself as a valuable partner for clients seeking to overcome challenging CMC issues, especially with complex modalities,” said Michelle Chen, Senior Vice President for Process Development and Manufacturing at Bionova. “With this new facility, all of our pre-GMP activities are co-located and integrated under one roof. We already see meaningful technical and efficiency gains as our PD teams can facilitate seamless technology transfer by scaling and training simultaneously.”

Congressman Ro Khanna (D-CA) commented, “Congratulations to Bionova Scientific on the opening of its new process development facility. Bionova is a native son of my hometown of Fremont and is now positioned to help biopharma drug makers move their innovations from early-stage compounds to commercial, life-saving drugs, including potential new cancer treatments.”

To learn more about Bionova, visit https://bionovascientific.com/

About Bionova Scientific

Bionova Scientific partners with innovators in the biologic industry to bring life-changing therapies to market. Founded in 2014 and acquired by Asahi Kasei Group in 2022, Bionova Scientific offers customers access to superior tools and technologies and an unwavering commitment to quality delivered with scientific excellence across the entire lifecycle. Bionova offers integrated CDMO services that span cell line development, process development to the cGMP manufacturing of complex proteins and antibodies. Our experienced Bay Area scientists bring proven expertise to overcoming discovery to first-in-human development challenges and scale-up. Bionova is a flexible and collaborative partner that has worked with leading biotechnology innovators from its new state-of-the-art facility in the San Francisco Bay Area.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit asahi-kasei.com and ak-bio.com.

Bionova Scientific:

Chris Halling (Orientation Marketing)

+44 (0)7580 041073

Chris.Halling@orientation.agency



Asahi Kasei North America:

Asahi Kasei America Inc.

Christian Okeefe

Christian.okeefe@ak-america.com



Asahi Kasei Europe:

Asahi Kasei Europe GmbH

Sebastian Schmidt

sebastian.schmidt@asahi-kasei.eu

Source: Asahi Kasei

FAQ

What is the size and purpose of Bionova's new Fremont facility?

The new 55,000 sq. ft. facility serves as a process development and pilot plant, designed to advance early-stage biologics to first-in-human trials and expand manufacturing capacity.

How does the new facility benefit AHKSY's Bionova operations?

The facility consolidates all pre-GMP activities under one roof, enabling seamless technology transfer, improved efficiency, and enhanced capacity to serve both early-stage and large biopharma clients.

What is the economic impact of the Biotech Bay region where AHKSY's new facility is located?

The San Francisco Bay Area's biopharma industry generates over $142 billion in economic activity and provides more than 328,000 direct and indirect jobs.

How many industry and community leaders attended AHKSY's Bionova facility opening?

Approximately 150 industry and community leaders attended the ribbon-cutting ceremony, including local government officials and business representatives.
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