Eden Biologics, Inc.

Bora Biologics, a subsidiary of Tanvex Biopharma born out of a spinoff from Bora Pharmaceuticals, is expanding again. Bora Biologics, a subsidiary of Tanvex Biopharma born out of a spinoff from Bora Pharmaceuticals, is expanding CDMO operations at its San Diego facility.The new project will add 8,075 square feet of production to the site.The additions will include a pair of 2,000-liter bioreactors and design plans that will accommodate future bioreactor expansion of up to 5,000 liters, Bora Biologics said in a May 20 press release.Costs associated with the expansion weren’t disclosed.“With this expansion, we will be able to offer our customers 2000L commercial capacity with the ability to purify modern high-titer cell culture processes,” John Mosack, Bora’s GM and VP of operations in San Diego, said in the release.Tanvex completed its acquisition of Bora’s CDMO business in January. In August last year, Bora Pharma took a 30.5% stake in fellow Taiwanese drugmaker Tanvex, which then rolled Bora’s CDMO business into its operations and rebranded the subsidiary as Bora Biologics.As part of that deal, Bora picked up Tanvex’s production facility in San Diego.Prior to the Tanvex deal, Bora Pharma was already on a tear to expand in the CDMO segment. In June of 2024, Bora spent $30 million to acquire Emergent BioSolutions' fill-finish drug product facility in Baltimore. That deal followed the January 2024 acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories for $210 million, which gave Bora its first presence in the U.S.In 2022, Bora purchased fellow Taiwanese company TWi Pharmaceuticals, picking up two manufacturing facilities, and it also bought Eden Biologics' CDMO business.

Bora Pharmaceuticals continued its global expansion push by buying a stake in Taiwanese drugmaker Tanvex Biopharma. Bora Pharmaceuticals extended its expansion tear by taking a 30.5% stake in fellow Taiwanese drugmaker Tanvex BioPharma, boosting the CDMO’s biomanufacturing capabilities.The deal, which is expected to be completed in the first quarter of 2025, will make Bora the largest shareholder in Tanvex. It also gives Bora access to Tanvex's commercial-scale production facility in San Diego, the CDMO said in an Aug. 27 press release.Tanvex boasts more than 100,000 square feet of biomanufacturing space and operates 1,000- liter bioreactors, which will complement Bora’s 500-liter bioreactors, Bora added. The companies "will combine their biomanufacturing facilities to create a global solution for biologics development and supply," according to Bora's release.Bobby Sheng, Bora Group’s chairman and CEO, will become chair of the merged organization.“This partnership will enable the combined entity to rapidly respond to evolving industry demands and policy developments, such as the BIOSECURE Act in the US, and capitalize on new opportunities in onshoring, friendshoring, and the growing CDMO demands driven by these policy changes,” Sheng said in the release. The investment in Tanvex is the latest move in Bora’s global expansion march.In June, Bora shelled out $30 million to snap up Emergent’s fill-finish drug product facility in Baltimore that offers clinical and commercial nonviral aseptic fill-finish services on four fill lines, including lyophilization, formulation development and support services.That acquisition followed January’s $210 million acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories that gave Bora a foothold in the U.S.In 2022, Bora purchased fellow Taiwanese company TWi Pharmaceuticals, gaining two manufacturing facilities and some niche technologies, and it also bought Eden Biologics' CDMO business.

The sale represents one piece in Emergent’s plan to deprioritize its CDMO business. The asset sale portion of Emergent BioSolutions’ sweeping restructuring plan is taking shape. In a $30 million deal, Emergent has agreed to sell its fill-finish drug product facility in Baltimore to growing Taiwanese CDMO Bora Pharmaceuticals, the two companies said Thursday. The 87,000-square-feet Camden facility offers clinical and commercial non-viral aseptic fill-finish services on four fill lines, including lyophilization, formulation development and support services. About 350 Emergent employees are expected to join Bora as part of the transaction, which is expected to close in the third quarter of 2024, according to Emergent. Bora, through a media aide, confirmed to Fierce Pharma via email that the company plans to keep all existing employees at the plant. “The decision to sell our Camden manufacturing facility is aligned with our multi-year plan to create a customer focused, leaner and more flexible organization, while we improve overall profitability and raise capital to reduce our debt,” newly minted Emergent CEO Joe Papa said in a statement Thursday. The Camden site doesn’t have the most pristine track record. Following an FDA Form 483, the plant was slapped with an FDA warning letter in 2022 that detailed problems related to equipment cleaning, aseptic sterilization techniques and procedures, and quality systems. The problems were deemed adequately addressed and the warning letter closed following another FDA inspection last summer. The sale represents one piece in Emergent’s plan to deprioritize its CDMO business. About two months into his CEO role, Papa in May unveiled a restructuring initiative to reduce the company’s workforce by about 300 employees and to shut down two manufacturing facilities, while exploring strategic alternatives for some other plants. The two facilities being closed are located in Baltimore-Bayview and Rockville, Maryland. The Camden facility belongs to the group of sites for which Emergent has been weighing its options. Besides sites in Winnipeg, Canada, and Lansing, Michigan, which Emergent said it will keep, the company also owns about 122,500 square feet of manufacturing and warehouse space in Canton, Massachusetts, where Emergent has scaled back operations. In contrast to Emergent’s shrinking interest in the CDMO field, Bora has been on an expansion spree. The Taiwanese company just established a U.S. footprint earlier this year with a $210 million acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories. The Upsher-Smith buy followed two acquisitions by Bora in 2022. Through the purchase of fellow Taiwanese company TWi Pharmaceuticals, Bora gained two manufacturing facilities and some niche technologies. The same year, Bora beefed up its biologics capabilities by acquiring Eden Biologic’s CDMO business. Buying the Camden sterile injectable fill-finish plant “not only demonstrates our commitment to our growth strategy and plans for expansion in North America, but also enables us to expand our offering for our biologics customers,” Bora CEO Bobby Sheng said in a statement Thursday. Without offering further details, Bora said it has “ambitious plans to enhance the newly acquired facility.” And the company is “always considering sites that are available,” Bora told Fierce Pharma. “We are planning to expand our operations across the US market to significantly enhance Bora’s position as a global competitor,” the company said. “As part of our growth strategy, we are constantly listening to our customer's needs to spot opportunities to provide the best possible service.”