Xpressions Blog

We share our insights and information about biologic drug development, including: innovative technologies that save time and create efficiencies with a goal of getting novel drugs to patients FASTER.

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GENE to GMP: Accelerating the development of life-changing biological medicines in a new European state-of-the art facility

May 30, 2022 7:03:00 AM

Biopharmaceutical companies are increasingly seeking service providers to help them reduce biologics manufacturing risks while increasing the speed to the clinic and ultimately the market. To be first in human and first to market for a novel biologic entity – or being first to market with a biosimilar in an emerging market – creates a transformational competitive advantage for any drug company. The development and manufacturing of biologics is a major, and often unpredictable, component of this timeline and challenges with the cell line or manufacturing process can add months or even years to the overall development time.

JSR Life Sciences acquired Selexis in June 2017 specifically to integrate Selexis with KBI (also a JSR Life Sciences Company) and provide industry partners with an unprecedented development and manufacturing package called “GENE to GMP.” GENE to GMP combines Selexis and KBI’s expertise to offer the industry best-in-class CDMO services, allowing biopharma companies to achieve faster time to clinic and to market while lowering manufacturing costs.

GENE to GMP process starts with cell lines developed with the Selexis SUREtechnology Platform, a suite of technologies that facilitate the rapid, stable, and cost-effective production of virtually any recombinant protein, from monoclonal antibodies (mAbs) to difficult-to-express proteins. Taking advantage of their incredibly robust and stable vector and expression technologies, Selexis is able to generate clonal research cell banks (RCB) for mAbs in as little as eight weeks. Selexis and KBI’s integrated workflow enables concurrent process, analytical and formulation development so as the final clones are selected based on optimal quality and productivity, key operating parameters are confirmed and the final manufacturing process is rapidly enrolled into KBI’s state-of-the-art single-use GMP facilities

In the fall of 2020, to further meet the needs of European clients and support the GENE to GMP process, JSR Life Sciences co-located Selexis and KBI Biopharma to a new state-of-the-art facility in Geneva, Switzerland. This expansion allows Selexis to meet increasing demand for its highly specialized mammalian cell line development technologies and services and for KBI to efficiently serve its European clients through its clinical cGMP biologics bulk drug substance manufacturing. Having both companies located within one facility in Geneva will allow Selexis and KBI to continuously innovate, drawing from the advanced technical resources within the region.

KBI and Selexis have a long history of success together, stretching back to 2012. KBI has performed GMP manufacturing with more than 40 Selexis-generated cell lines that have yielded industry-leading titers: 3 to 9.5 grams/L for mAbs and ~3 to 10 g/L for bispecifics and Fc fusions.

Through GENE to GMP, Selexis and KBI are committed to delivering exceptional quality and value within a highly accelerated timeline. By predictably supplying cGMP drug substance for your clinical study, GENE to GMP allows you to focus on the other critical components of your development program.

Learn more by visiting the GENE to GMP lounge at the JSR Life Sciences, Selexis, and KBI Island #1337.

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