The next generation of biologics present many challenges for both drug developers and their CDMO partners. Advancing molecules into clinical development and scaling up manufacturing of these increasingly complex biologics, requires advanced process development and analytical testing and highly specialized manufacturing technologies. For CDMOs it requires working faster, safer, and more efficiently, leveraging the right technologies, to drive growth in the industry.

With recently expanded European operations and a newly updated facility in Geneva, Switzerland, JSR Life Sciences aims to increase engagement with a broader European client base. JSR will co-locate two of its affiliates - KBI Biopharma and Selexis SA – in 8,700 square meters of the “Stellar 32” facility.

Creating new capabilities by linking the core strengths of its affiliates, KBI Biopharma’s expanded facility will enable the company to offer clinical cGMP biologics bulk drug substance manufacturing for European clients and Selexis’ new workspaces will allow the company to meet the increasing demand for its highly specialized mammalian cell line development technologies and services.

Tim Lowery, President of JSR Life Sciences discusses the companies recently expanded European operations, some of the main challenges biopharma companies face developing and manufacturing today’s biologics, and the capabilities and technologies needed to overcome them. –KB

Contract Pharma: What new capabilities and services will be available as a result of the company’s recently expanded European operations?

Tim Lowery: JSR Life Sciences has best-in-class companies focused on translating our customers' ideas into actual products that are improving patients’ lives, which enables us to offer large molecule expertise to clients from target selection all the way to commercial manufacturing.

With this particular expansion in Geneva, Switzerland, there are certain technical updates we made to KBI and Selexis’ facilities in line with JSR initiatives to innovate, modernize and digitize across all of our affiliates. For example, KBI’s expansion includes two 2,000L single-use cGMP manufacturing trains with highly advanced process development and analytical testing labs on site. The Selexis space includes, in addition to new standard cell line development suites, the two separate cell culture suites to accommodate quarantined client-specific cell lines or client-dedicated cell line spaces. The co-location of the services for these two companies provides additional benefits for our global client base and the strategic location in Switzerland provides easy access for our European clients.

In addition, this co-location provides new capabilities for our partners by linking the core strengths of these companies. For example, the two companies have joined forces to provide industry partners working with both KBI and Selexis the “Gene to GMP™ in 9 Months” service, which can help biopharma companies achieve faster time-to-market and lower their development costs. Gene to GMP™ brings together the collective expertise of both KBI and Selexis to deliver a seamless process for rapid process development and cGMP manufacturing of protein therapeutics without sacrificing productivity or quality. For conventional mAbs and other readily expressible proteins that are amenable to a platform purification process, partners provide Gene to GMP™ with their gene sequence. Our companies can advance the development process all the way to clinical manufacturing in an accelerated fashion. This technology can also be applied to other complex and challenging constructs with similar benefits.

CP: What are some of the main challenges Biopharma companies face developing and manufacturing today’s biologics?

TL: Keeping up with the technology and the science in addressing patient needs is an innate challenge for the CDMO industry. Thanks to some of the best minds in the world working to help patients, treatments and drug candidates are more advanced, more complex, and those leaps forward are accelerating with the advent of new technologies. We need to keep pace with these innovations and make sure our expertise can not only accommodate, but enhance, these leaps forward. JSR Life Sciences has dealt with this by going out and recruiting some of the best in the business to make sure we are on the cutting edge of technology and life science innovations. With our affiliates Crown Bio, Selexis, KBI Biopharma, and MBL, JSR Life Sciences has positioned ourselves to access data, expertise, and resources necessary to de-risk the investments necessary for the next generation of biologics.

CP: What capabilities and technologies are needed to overcome challenges in cell line development and manufacture?

TL: The CHO cell line development field has evolved immensely over the last ten years, with JSR Lifesciences leading the way through the Selexis expression technology and KBI’s advanced process development and analytical capabilities. The unique genetic engineering technology platform of Selexis has led to unpreceded CHO expression productivities that have helped their partners advance more than 135 molecules into clinical development. Selexis continues to push the envelope of cell expression by continually investing in new technology development and by leading the field in new equipment adoption. KBI Biopharma is known for its strong focus on science in process and analytical development, which enables high success rates in the development of complex molecules. Their CMC expertise and cGMP manufacturing infrastructure allows for a seamless transition from clinical supply to commercial launch and beyond.

CP: In what area(s) of JSR Life Sciences’ business do you see the most growth?

TL: Right now, our large molecule capabilities are our foundation and I believe will continue to grow as therapeutic needs continue to be better understood, our affiliates grow, and as we are able to leverage synergies among them. In addition, I believe treatment intelligence is a burgeoning opportunity for our industry, namely biomarker and companion diagnostics. The ability to discover and advance biomarkers, which can in turn facilitate companion diagnostics, and by itself would make a treatment more likely to be successful, is a highly attractive concept for patients, providers, and payors. Building our expertise in being able to identify the right patients for the right drug is one of the major growth opportunities we’re working through.

CP: What do you anticipate for future needs in the outsourcing space?

TL: Working faster, safer, and more efficiently will continue to be the prevailing needs for CDMOs. Being able to identify and leverage the right technologies will be key to sustaining growth and leadership in the industry. JSR Life Science’s ‘single chain’ approach is meant to increase speed to market, driving value to our clients by providing the option to leverage world-class expertise from identifying molecules to delivering commercial batches of drug product. This also allows the technology experts – in cell lines, cGMP manufacturing like with our European facility expansion – to stay at the forefront of scientific advances and the needs of advanced therapy discovery and development. And, in turn, we can deliver these capabilities to our clients.