KBI Biopharma
Simplifying Drug Development Using Technology

It’s no secret that 2020 has thrown a lot of curveballs, with the shortage of supplies nearing the top of that list. An unanticipated consequence of the COVID-19 pandemic is the disruption caused by the virus, exposing inefficiencies in many areas of our daily life. Manufacturers have learned a lot about their capabilities during this pandemic, and one of the biggest obstacles was adapting to scarcity of supplies, evident from the shortage of vaccines during the pandemic. An answer to this is to outsource to Contract Manufacturing Organizations (CMOs) that serve other pharmaceutical companies on a contract basis for drug development and drug manufacturing. Outsourcing allows subject matter experts at the CMO to present a roadmap for a successful R&D strategy. The selection of a CMO with a proven track record for quality and value is a vital component contributing to profitability for manufacturers on the path to commercialization. In addition, growing pressure on pharmaceutical and medical device companies to follow stringent timelines has increased the demand for outsourcing development and manufacturing activities to CMOs. One such leading CMO in the European market is KBI Biopharma, a JSR Life Sciences company, which includes cell line development, process development, clinical and commercial manufacturing under its umbrella.

KBI’s expertise in biophysical and biochemical characterization of proteins, as well as a broad range of product development services, make them an excellent partner. Their contract development and manufacturing services are built on a strategic cornerstone of profound diagnostic capabilities.

Cell line development of KBI Biopharma has industry-leading titers of up to 10g/L with a robust track record of more than 60 ongoing clinical trials and rapid cell line development of 12 weeks. The company’s manufacturing capability is the first CMO to have a 2000 liter single-use bioreactor and ensures end-to-end single-use technology. Moreover, they have more than 16 years of contract analytical service experience and over 3000 independent projects completed.

With potency assays playing a critical part in this process, drug developers must prove that their product candidates are safe and effective (potent). This led to KBI Biopharma completing Eurofins DiscoverX Products Specialized Bioassay Certification Program. “We are pleased to receive this certification from Eurofins DiscoverX and to be part of the important work the company is doing to fully leverage the utility of functional cell-based assays in biologics drug development,” said Dirk Lange, President and CEO at KBI Biopharma and CEO of Selexis SA.

KBI’s extensive track record of successful process development and manufacturing programs results from their unique approach of applying the insights gained from advanced biophysical protein characterization methodologies to develop robust and scalable processes. KBI has served over 300 clients globally, and in every testimonial and survey of their clients, KBI is viewed as the most collaborative and responsive of all the contractors with whom their clients work.

The global healthcare contract development and manufacturing organization market size is anticipated to reach USD 388.3 billion by 2028, expanding at a CAGR of 8.6 percent. Keeping this in mind, KBI Biopharma is on a path of expansion in its future roadmap. A newly expanded, 5,600-square-meter state-of-the-art facility will house biologics manufacturer KBI Biopharma and cell line developer Selexis at Geneva, creating more than 200 technical positions in development, operations, and quality assurance. In addition, a first full-scale current Good Manufacturing Practices (cGMP) batch is projected in the third quarter of 2022, along with a dual 2,000 L Xcellerex™ single-use bioreactor upstream suite with associated downstream processing. “This purpose-built facility is a demonstration of our continued commitment to providing a local presence for European customers. Collocating KBI with Selexis offers an easy, simple transition from Selexis’ innovative cell line technologies and KBI’s world-renowned expertise in biologics manufacturing,” explains Lange.