A Faster, Flexible Alternative to Conventional Outsourcing for Biologics

For many developers of new biologics, outsourcing clinical or commercial manufacturing with a contract manufacturing organization (CMO) makes good sense. Dozens of capable CMOs offer ready capacity to companies who can’t afford the time, capital or risk involved in building their own biomanufacturing capacity.

Of course, the convenience of instant access to a CMO’s infrastructure comes at a steep price: Many CMOs use proprietary cell lines, media, and other technology that will limit a drug developer’s options in the future. Process development work done by a CMO may create barriers to future technology transfer, effectively marrying drug developers to that CMO indefinitely. This creates a structural disadvantage, resulting in economics that may limit the future value of a drug to its developer.

How to Add Long-Term Control to the Speed and Economics of Outsourcing: The FlexFactory® biomanufacturing platform from Xcellerex provides a new level of flexibility to biomanufacturing structure and deployment. When coupled with world class biomanufacturing operations, this platform becomes a complete biomanufacturing solution that features the speed and capital restraint of traditional outsourcing with the long-term control associated with your own captive biomanufacturing operations. In other words, you can use Xcellerex as your outsourced manufacturing partner on a “bridge” basis (short or long-term) while also maintaining the freedom to TransPlant™ manufacturing operations to your facility anywhere in the world when the time is right for you.

Unique Options Enabled By a Unique Business Model: Xcellerex is a technology and equipment company, but our roots are in designing and running biomanufacturing operations. As a result, we structured the company to include expertise and services that we know are essential to smoothing our clients’ pathway to new biomanufacturing capacity.

Xcellerex Equipment Platform

Xcellerex offers FlexFactory controlled environmental modules, as well as a line of single-use bioreactors and mixers that have become the standard in the bioprocess industry. Our XDR single-use bioreactors are fully integrated, stirred-tank systems that deliver the performance and scalability of stainless steel systems with the convenience and quality of single-use technology. XDR reactors are fully characterized and feature a process modeling database that enables instantly optimized process scale-up or tech transfer. XDRsystems are available with working volumes ranging from 10 Lto 2,000 L. Xcellerex also offers XDM Quad Mixers and a full complement of related single-use assemblies.

FlexFactory Services Platform

Xcellerex supports its equipment and platform with a unique portfolio of services. From process design and optimization to facility design to process equipment integration, Xcellerex can help ease the transition to single-use technologies. Through its TransPlant™ services, Xcellerex can “bridge” manufacture a partner’s biomolecule at our GMP facility while the partner’s FlexFactory is constructed, validated, and TransPlanted to the partner’s site. This unique model both accelerates time to clinical and commercial manufacturing and allows partners to manage the development and market risk of adding manufacturing capacity.

Xcellerex is uniquely able to help biotech companies produce drugs for clinical or commercial use with the same speed and convenience as a conventional CMO— while also helping the client establish the knowledge and infrastructure required to control its long-term destiny. In addition, Xcellerex now can offer clients access to commercial biomanufacturing partners who use flexible FlexFactory-based suites in their innovative CMO operations.

Integration and Process Know-How

Xcellerex is unique among equipment manufacturers in that we offer years of biomanufacturing operations experience, and we use our equipment every day. Our team’s experience in designing processes, integrating hardware and software, and designing optimized single-use facilities enables us to help our customers streamline their road to new capacity, while avoiding many of the first-time mistakes that lurk around every corner. More than our innovative equipment design and services offerings, it is this hands-on knowledge that our current customers value most in our partnerships.

About the Author

Author Details
Kenneth Clapp is senior director of marketing and product management at Xcellerex, Inc., 170 Locke Drive, Marlborough, MA 01752; [email protected]; www.xcellerex.com.