The installation of the new vial, syringe, and cartridge line is expected to take place throughout the coming year.
Due to a rise in demand, Bora Pharmaceuticals Co., Ltd., a contract development and manufacturing organization (CDMO), will reportedly be expanding its 87,000 square-foot sterile fill-finish capacity at its Baltimore plant.1
The CDMO will be installing its branded AST GENiSYS C automated vial, syringe, and cartridge line, which will be done over the course of 2026. With capabilities to produce for clinical and small-scale, high-value substance commercial supply, it is expected to follow state-of-the-art full isolator conditions.
“Bora is more frequently seeing demand for drug product fill and finish of potent drug candidates and approved treatments, as well as for rare and orphan diseases,” commented J.D. Mowery, president of Bora’s CDMO division. “The addition of a precision small-scale isolator line adds to our overall capacity, and working in concert with our existing large-scale lines, increases our flexibility and scalability. I look forward to adding to our capabilities in the US so that we remain ready to meet rising demand from clients, both domestic and international.”
Not only does the facility offer drug product manufacturing services for sterile injectables, it also provides clinical and commercial non-viral aseptic fill/finish services for vials and pre-filled syringes on a total of four fill lines, along with terminal sterilization, lyophilization, serialization, packaging and other support services.
Bora has been quite involved with game-changing moves as of late. This past January, the company was acquired2 by Tanvex BioPharma, Inc., a CDMO that specializies in biologics and biosimilars. As a result, Tanvex’s CDMO services will now operate under the Bora Biologics name.
“The completion of this acquisition marks a pivotal moment for Tanvex and Bora Biologics,” commented Stephen Lam, Tanvex’s CEO who will also be leading the newly formed company. “We are adopting the name Bora Biologics to honor the legacy, reputation, and partnership power of a Bora brand, while seamlessly integrating its strengths with our commercialization success in the US and our innovative vision and commitment to advancing biologics development. We believe that Bora Biologics will play a pivotal role in the future of biologics development.”
The deal primarily combines Tanvex’s biosimilar development know-how with Bora’s early-stage biologics CDMO services in Taiwan.
And just last week, Bora revealed that it was expanding its San Diego commercial manufacturing facility by adding both upstream and downstream good manufacturing practice (GMP) processing services.
Among the new additions, the features will include an additional 8,075 square feet of manufacturing space consisting of:
“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,” said John R. Mosack, general manager & vice president, operations of Bora’s San Diego site. “In addition to the two 2000L Cytiva bioreactors we are installing now, we will have the space to grow with our customers and meet their evolving needs.”
References
1. Bora Adds Automated Fill/Finish Line in Baltimore. Bora Pharmaceuticals. May 29, 2025. Accessed June 2, 2025. https://bora-corp.com/bora-adds-automated-fill-finish-line-in-baltimore/#:~:text=(%E2%80%9CBora%E2%80%9D%20or%20%E2%80%9Cthe,its%20facility%20in%20Baltimore%2C%20Maryland.
2. Tanvex BioPharma Completes Acquisition of Bora Biologics, Launching New Era in Biologics Development. Bora Pharmaceuticals. January 20, 2025. Accessed June 2, 2025. https://bora-corp.com/tanvex-acquisition-bora-biologics/
3. Bora Biologics Expands San Diego Facility for 2000L+ Scale Biologics Manufacturing, Boosting CDMO Capacity. Bora Pharmaceuticals. May 27, 2025. Accessed June 2, 2025. https://www.borabiologics.com/press-releases/bora-biologics-expands-san-diego-facility-for-2000l-scale-biologics-manufacturing-boosting-cdmo-capacity
An Exploration of Compounding Practices
May 22nd 2025In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.
