Xcellerex, Inc. was founded in September 2003 and has established a position of leadership for alternative modular manufacturing facilities and integrated disposable technologies for biomanufacturing.
Through contract services and technology offerings, Xcellerex has been distinguished with the 2005 Biomanufacturing Technology of the Year Award from Frost & Sullivan.Company Description:
Xcellerex is a technology integration company offering disposable technologies and top quality contract manufacturing services to the biopharmaceutical industry. The company's management team has unique and significant experience in drug development, taking biologics from the pre-clinical development to FDA approval.
Xcellerex has created a new paradigm for building manufacturing systems in which process automation (including electronic batch records), fully disposable manufacturing components (XDR and XDM) and portable modules (FlexFactory), have been integrated to create an alternative to traditional stainless steel manufacturing facilities.
Xcellerex's "Try and Take" business model gives maximum flexibility to our customers and provides them with cost effective manufacturing capabilities.
The company is committed to the customer's success in 'speeding medicines to people' by providing them with excellent service and technologies.
Xcellerex Disposable Bioreactors (XDR) are scaleable, disposable stir tank bioreactors, which operate as stand-alone skid-mounted units or integrate into a full manufacturing train. Functionality can be customized from a list of options to allow each user maximum flexibility and integration to existing legacy manufacturing operations. XDR's are available in 200, 500 and 1,000 L working volume. Smaller scale models will be available in the future.
Xcellerex Disposable Mixer (XDM) is an efficient, disposable mixing system capable of mixing high viscosity solutions, buffers, process streams, and products. With variable speed and up/down mixing capability, XDMs are available in 100 to 1,000 L working volume scales.
FlexFactory is Xcellerex's modular biologics manufacturing platform designed to keep the operator outside of the controlled space and accommodate new processes or process step changes, making it the ideal technology to handle a wide range of biological manufacturing processes. An automated control system and electronic batch record can be integrated, or integration of legacy systems is possible. The FlexFactory platform allows Xcellerex greater flexibility in responding to its clients' needs for contract manufacturing and also provides a fully integrated 'take-away' technology to enable manufacturing directly by our clients. The Flex Factory has been reviewed by FDA.
As part of manufacturing services Xcellerex's capabilities range from cell line construction through cGMP manufacturing of biological products including monoclonal antibodies, vaccines, cytokines, and other therapeutic biological products.
Process Development Using PDMax Platform
Cell Line Development and Clone Selection: High throughput screening to accelerate the development of stable cell lines and robust manufacturing processes. Increase the ability to evaluate thousands of transfectants to find the highest producing cell lines.
Media Optimization: Optimize key media components early in the development stage, reducing regulatory risks associated with process changes for scale-up to commercial scale manufacturing. You own the formulation!
Formulation Development: Test different excipients at various concentration, pH, ionic strength, and product concentration in factorial experimental design.
Purification Development: Screen multiple resins, binding, wash, and elution conditions as well as the sequence of binding chemistries for optimal recovery and product quality.
cGMP Manufacturing Services
Mammalian Capacity: 100 L to 1,000 L scale using disposable reactors (XDR) and Flex Factory Modular Manufacturing Facility.
Microbial Capacity: 250 L cGMP capacity for yeast and bacteria in operation and available for contract services.