While many headline-grabbing biologics and advanced therapeutics like cell and gene therapies are approved as injectables, CDMOs Bora Pharmaceuticals and Corealis Pharma understand that oral solid dose drugs like tablets, capsules and pills continue to form the backbone for much of medicine.
In turn, the contract manufacturers are joining forces to create a new end-to-end CDMO offering for oral solid dose (OSD) development and production. The strategic alliance will be designed to simplify the drug development process and offer a more scalable route to market through a single contracting source, Bora and Corealis said in a Dec. 9 press release.
The manufacturers have come together on the project out of a mutual understanding that pharmaceutical production has become “increasingly complex, requiring specialized partners at every stage of development,” according to the announcement.
Under the new alliance, Bora aims to wed its global commercial infrastructure with Corealis’ formulation and clinical-scale manufacturing know-how to create a contract development and production pathway that the partners pledge will form a “simple, more efficient route to bring new medicines to patients faster and more reliably.”
To help streamline work with clients, Bora and Corealis note that they will offer “unified project management and aligned quality.” The goal, to hear the partners tell it, is to help biotechs and pharmas minimize outsourcing risk by using an “integrated CDMO alliance” from drug discovery all the way up to market launch.
“Emerging biotechs often face timeline and flexibility challenges when scaling promising therapies from clinical to commercial lots,” David Leroux-Petersen, Corealis’ CEO, said in a statement. “The alliance with Bora provides our early-stage partners with a clear, fast, seamless, simple path to phase III manufacturing and commercial launch.”
Founded in 2005, Corealis is a privately held CDMO based in Québec, Canada, that specializes in OSD medications. The company offers customized formulation development, analytical and manufacturing services for drugmakers around the globe.
For its part, Bora—which is based in Taiwan and has a substantial North American presence—carries out contracting work on a range of dose forms, including OSD, as well as liquid, semi-solid, biologic and sterile injectable pharmaceuticals.
The CDMO has been gradually growing its reach in recent years, notably taking up a 30.5% stake in fellow Taiwanese drugmaker Tanvex BioPharma last August. The deal made Bora Tanvex’s largest shareholder and also gave the CDMO access to a commercial-scale production facility in San Diego.
Back in May, Bora Biologics—a new Tanvex subsidiary—announced plans to add more than 8,000 square feet of additional production space at the San Diego site, including the installation of a pair of new 2,000-liter bioreactors. As part of the project, Bora Biologics is designing the facility to eventually accommodate a future bioreactor expansion of up to 5,000 liters.