Taiwan-headquartered contract development and manufacturing organization Bora Pharmaceuticals announced plans to expand sterile fill-finish capacity at its Baltimore, Maryland facility in response to growing demand for drug product services, particularly for high-value substances and treatments for rare diseases.
Automated Line Installation to Begin
The company will install a new AST GENiSYS C automated vial, syringe, and cartridge line over the next year at its 87,000-square-foot Baltimore facility. The new line will operate under state-of-the-art full isolator conditions and is specifically designed for clinical and small-scale commercial supply of high-value substances.
"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.
Enhanced Capacity and Flexibility
The precision small-scale isolator line will complement Bora's existing large-scale manufacturing capabilities, creating increased flexibility and scalability for the company's operations. The Baltimore facility currently provides drug product manufacturing services for sterile injectables and offers clinical and commercial non-viral aseptic fill-finish services for vials and pre-filled syringes on four fill lines.
"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," Mowery explained.
Comprehensive Manufacturing Services
Beyond fill-finish operations, the Baltimore facility offers lyophilization, terminal sterilization, analytical services, stability testing, packaging and serialization, and additional support services. The expansion positions Bora to better serve rising demand from both domestic and international customers.
Global Manufacturing Network
In addition to its Baltimore operations, Bora maintains manufacturing sites in Taiwan and operates a 170,000-square-meter facility in Mississauga, Ontario, designed for flexible, high-quality, cGMP drug contract manufacturing. The company specializes in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.
