KBI Biopharma didn’t set out to be a contract development and manufacturing organization (CDMO) giant — it started with a centrifuge.
Not just any centrifuge, but a vertical, disposable model developed by Kinetic Biosystems Incorporated in Georgia. Unlike standard models, which rely on a horizontal spinning motion that can create uneven sedimentation and require frequent cleaning, a vertical design allows for more uniform separation of biomaterials, improved fluid dynamics, and reduced shear stress — critical for delicate biologics.
The disposable aspect added another advantage, minimizing contamination risks and cutting down on turnaround time between batches. This early innovation set the tone for KBI’s approach: solve complex technical challenges with smarter, science-driven solutions.
By 2003, KBI had fully embraced its CDMO identity, and by 2010, it was expanding its mammalian production capabilities in North Carolina.
Today, KBI has six sites across North Carolina, Colorado, and Geneva, turning its early expertise in analytical problem-solving into a full-scale biomanufacturing operation.
Its specialty? Tackling the toughest molecules.
Science first, always
From the beginning, KBI positioned itself as a science-focused CDMO, taking on molecules others couldn’t manufacture and creating custom solutions for complex proteins.
“We became well known for solving the toughest problems,” says Chief Scientific Officer Sigma Mostafa. “A lot of our pipeline comes from customers who tried elsewhere and hit a wall. We built our reputation on getting those products across the finish line.”
KBI’s early years were defined by its work with first-in-human molecules — high-risk, high-reward projects that required deep technical expertise. That focus paid off. Many of those molecules have since advanced through late-stage development, with several now in commercial production.
Balancing early-stage innovation with commercial-scale execution is the next challenge.
“We had to shift from being just a problem solver to a full-spectrum CDMO,” Mostafa says. “Now, we’re not only accelerating biomolecule development but also seeing them through commercialization, which requires a different mindset and infrastructure.”
Balancing innovation with execution
As its portfolio expanded, KBI invested in building a seamless pipeline from early development to commercial launch, ensuring that molecules progress efficiently through every stage of their lifecycle. This shift required more than just additional capacity — it demanded smarter systems, streamlined operations, and a future-ready infrastructure capable of balancing the complexities of early-phase development with the rigor of commercial-scale manufacturing.
Key to that strategy is KBI’s proprietary digital platform, Program View, a real-time data management and communication hub designed to eliminate inefficiencies across the development spectrum. Unlike traditional CDMO-client interactions, which often involve cumbersome email chains, scattered data reports, and time-consuming manual updates, Program View centralizes all project-related information into a single, accessible interface.
“Everything, from lab data, client communication, regulatory reviews, feeds into one system,” Mostafa explains. “Customers can see real-time updates without the usual back-and-forth. It saves time and keeps projects moving.”
The system provides hands-free data transfer, automatically pulling processing equipment and analytical results through an integrated Electronic Laboratory Notebook (ELN). This reduces transcription errors, ensures data integrity, and allows for seamless integration of analytics into decision-making.
Clients can track progress live, minimizing the need for status update meetings and redundant reporting. The platform also consolidates quality documentation, facilitating regulatory submissions by ensuring that all necessary compliance data is stored, categorized, and readily available. By eliminating the inefficiencies of manual data handling, Program View enables KBI’s scientists to focus on innovation rather than administrative tasks, ultimately accelerating project timelines and reducing costs.
KBI has also been an early adopter of advanced processes and cell engineering technologies that set it apart from conventional CDMOs. KBI has also made significant investments in the antibody-drug conjugate (ADC) space, positioning itself as a leader in an increasingly vital area of biopharmaceutical development. ADCs represent one of the fastest-growing categories in oncology and other therapeutic areas.
“We have the chemistry expertise for ADC conjugation and are actively building capabilities for handling cytotoxic drugs,” says Mostafa. “By 2025, we aim to offer full process development for these complex molecules.”
Currently, KBI has extensive experience in ADC characterization and early-stage process development, including conjugation strategies that enhance drug stability and bioavailability. And on the cell line development front, KBI has pioneered cutting-edge cell line engineering strategies. KBI has developed a premium microbial strain and adopted a unique mammalian expression system inherited from/powered by Selexis.
By combining high-performing proprietary CHO cell line to strong vector design including unique genetic elements, Selexis platform ensures that each molecule produced at KBI is optimized for both efficiency and manufacturability. This translates into increased expression levels, improved protein fidelity, and sustained cell line stability.
The company’s proprietary microbial platform, PureColi, for example, boasts five times the productivity of standard E. coli systems, enabling more cost-effective and scalable biologics production. For mammalian cell lines, KBI has developed advanced screening and selection techniques that enhance monoclonal antibody (mAb), multispecific production and glycoprotein, reduce unwanted mutations, and ensure high-purity protein output.
Through these strategic advancements — a fully integrated digital ecosystem, next-generation purification and cell engineering, and a deepening focus on ADCs — KBI is solidifying its reputation as a CDMO that doesn’t just manufacture molecules but optimizes and refines them from inception to commercialization.
By staying ahead of industry shifts and continuously improving its technological and operational framework, the company is ensuring that its clients’ molecules reach patients faster, safer, and more efficiently than thought possible.
Building the future
Looking ahead, KBI is also betting big on its in-house microbial and mammalian cell lines.
“With PureColi, we can push productivity to new levels while maintaining quality,” Mostafa says. “It’s a game-changer for clients working in peptides and complex proteins.”
With a portfolio that spans first-in-human trials to commercial production, KBI isn’t just another CDMO — it’s a solutions provider for the toughest challenges in biomanufacturing.
“We’ve built a model that works across the full lifecycle,” Mostafa says. “And we’re just getting started.”
