Bionova Scientific, U.S. biologics CDMO of the Asahi Kasei Group, to establish a facility in Texas and launch plasmid DNA business

Rhea-AI Summary

Bionova Scientific, a U.S. biologics CDMO and subsidiary of Asahi Kasei Medical, has announced plans to establish a new plasmid DNA production facility in The Woodlands, Texas. This move aligns with Asahi Kasei Group's medium-term management plan, 'Be a Trailblazer,' and aims to leverage the expanding biopharmaceutical market. The new facility will focus on process development from early 2025 and GMP manufacturing from 2026. Bionova aims to support the growing demand for cell and gene therapies, mRNA vaccines, and antibody drugs by utilizing its established expertise and network. The global plasmid manufacturing market is expected to grow at double-digit rates, presenting a significant business opportunity.

Positive

• Establishment of a new facility in Texas expands Bionova's production capabilities.
• Focus on plasmid DNA taps into a rapidly growing market.
• New facility supports cell and gene therapies, mRNA vaccines, and antibody drugs.
• Bionova's expertise in process development and GMP manufacturing is a strategic advantage.
• Service provision to begin in 2025 and 2026 aligns with market growth projections.
• Expansion aligns with Asahi Kasei Group's 'Be a Trailblazer' growth strategy.
• Increased market presence in the U.S. biopharmaceutical sector.

Negative

• Significant capital expenditure required for the new facility.
• Service provision timeline delays revenue generation until 2025-2026.
• Potential operational risks associated with establishing a new facility.
• Market competition in plasmid DNA manufacturing is intensifying.

TOKYO & NEW YORK & DÜSSELDORF, Germany--(BUSINESS WIRE)-- Asahi Kasei Medical's U.S. subsidiary Bionova Scientific, a full-service biologics CDMO, has decided to launch a new business line providing services leveraging plasmid DNA, and establish a dedicated facility for this purpose in Texas, the U.S.

Shown is the Research Forest in The Woodlands, Texas, the planned future site of Bionova’s pDNA facility. (Photo: Business Wire)

The bioprocess business of Asahi Kasei Medical is one of the 10 Growth Gears (GG10), businesses to lead the next phase of growth, under the Asahi Kasei Group’s medium-term management plan focused on the theme “Be a Trailblazer.” With the expansion of the biopharmaceuticals market, Asahi Kasei Medical has obtained further growth opportunities by entering the CRO (contract research organization) business and CDMO (contract development and manufacturing organization) business while leveraging its customer base and brand strength in addition to expanding established businesses such as Planova™ virus removal filters.

As a biologics CDMO that provides process development and manufacturing services to pharmaceutical companies, Bionova is well regarded for its capability of process development for complex next-generation antibody-based drugs whose manufacture tends to be difficult. To broaden its services portfolio, Bionova looked for opportunities to enter new therapeutic modalities such as cell and gene therapies, which are expected to grow rapidly.

Plasmids are DNA molecules that exist in the cells of microorganisms such as E. coli. They are increasingly used as important starting material in fields of biotechnology such as cell and gene therapies, mRNA vaccines, and antibody drugs. The global plasmid manufacturing market is expected to grow at double-digit rates over the next several years due to the rapid growth of new modalities such as cell and gene therapies. Bionova has decided to contribute to accelerating the growth of such new modalities by leveraging its expertise of manufacturing process development, GMP manufacturing know-how, flexible customer support, and industry network in the targeted new modalities.

For process development and GMP manufacturing of plasmids, Bionova will establish a new facility in The Woodlands, Texas, the U.S. Service provision is scheduled to begin in the first half of 2025 for process development and in the first half of 2026 for GMP manufacturing.

Asahi Kasei Medical aims to contribute to the development of the healthcare industry while further driving the growth of the Health Care sector of the Asahi Kasei Group by providing innovative and exceptionally reliable products and services that enable improved safety, increased productivity, and the stable supply of biotherapeutics.

Please refer to the press release dated April 19, 2022
“Asahi Kasei Medical to acquire Bionova Scientific, U.S.-based biopharmaceutical CDMO”
https://www.asahi-kasei.com/news/2022/e220419.html

Please refer to the press release dated February 2, 2023
“Bionova Scientific, U.S. biologics CDMO of the Asahi Kasei Group, expands manufacturing capacity”
https://www.asahi-kasei.com/news/2022/e230202.html

View source version on businesswire.com: https://www.businesswire.com/news/home/20240603320522/en/

North America:

Asahi Kasei America Inc.

Christian OKeefe

christian.okeefe@ak-america.com

Europe:

Asahi Kasei Europe GmbH

Sebastian Schmidt

sebastian.schmidt@asahi-kasei.eu

Source: Asahi Kasei Medical Co., Ltd.

FAQ

What is Bionova Scientific planning to establish in Texas?

Bionova Scientific is planning to establish a new plasmid DNA production facility in The Woodlands, Texas.

When will Bionova's new facility in Texas start providing services?

The facility will start process development services in the first half of 2025 and GMP manufacturing in the first half of 2026.

What new business line is Bionova Scientific launching?

Bionova Scientific is launching a new business line focused on plasmid DNA production.

What market is Bionova aiming to support with its new facility?

Bionova aims to support the market for cell and gene therapies, mRNA vaccines, and antibody drugs.

What is the expected growth rate for the global plasmid manufacturing market?

The global plasmid manufacturing market is expected to grow at double-digit rates over the next several years.