Bristol Myers Squibb Receives U.S. FDA Approval of New State-of-the-Art Cell Therapy Manufacturing Facility in Devens, Massachusetts

Rhea-AI Impact

(Low)

Rhea-AI Sentiment

(Neutral)

Tags

fda approval

06/08/2023 - 04:16 PM

The company’s third commercial CAR T manufacturing facility in the U.S. further extends Bristol Myers Squibb’s leadership in cell therapy

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved commercial production at the company’s newest cell therapy manufacturing facility in Devens, Massachusetts. The Devens site is a critical component of BMS’ expanding global cell therapy manufacturing footprint for long-term supply of the company’s cell therapy portfolio.

“The Devens facility integrates the latest state-of-the-art technology in the industry with top talent in the Boston area that will take us into the next phase of our cell therapy journey,” said Karin Shanahan, executive vice president, Global Product Development & Supply, Bristol Myers Squibb. “We are working diligently to increase our product capacity through new sites like Devens and by implementing innovative manufacturing solutions that help patients in need.”

Manufacturing autologous cell therapies is both operationally and technically complex because they are uniquely created using an individual patient’s own T cells as the starting material. Each batch of engineered T cells is manufactured individually and infused back to the original cancer patient. It is important to develop reliable quality supply with rapid turnaround time. The expansion of the company’s global manufacturing footprint is critical to supplying these products to patients with unmet needs around the world.

“Bristol Myers Squibb’s vision of putting more patients on a path to potential cure starts with delivering on the promise of our current product portfolio and future pipeline,” said Lynelle Hoch, senior vice president, Global Cell Therapy Franchise Lead, Bristol Myers Squibb. “Today’s approval underscores our commitment to deliver our transformational CAR T cell therapies to more patients.”

The new 244,000 square foot cell therapy manufacturing facility represents the second significant expansion of BMS’ 89-acre Devens site, which has been developing, producing, and testing clinical and commercial medicines for over a decade. The Devens facility creates over 500 new cell therapy jobs and reflects BMS’ continued leadership and growth in the Boston area’s dynamic life sciences community. BMS also operates two R&D facilities in Cambridge, Massachusetts and will bring these two sites together into a new building at Cambridge Crossing later in 2023.

Devens adds to the company’s robust global network of three state-of-the-art cell therapy manufacturing facilities in Bothell, Washington; Warren, New Jersey; and Summit, New Jersey, with another manufacturing site in development in Leiden, Netherlands. BMS recently announced the addition of a new manufacturing facility and its operations for in-house viral vector production in Libertyville, Illinois, further strengthening the company’s cell therapy capabilities.*

*The new U.S. facility is planned to transition to Bristol Myers Squibb over the course of 2023, subject to the fulfillment of applicable closing conditions.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products and the transaction. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, any delay or inability of Bristol Myers Squibb to realize the expected benefits of the transaction. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Related Content:

corporatefinancial-news