Xcellerex, Inc.

Dec 01, 2006
By BioPharm International Editors
Volume 19, Issue 12

Company Description

Xcellerex is a technology integration company offering disposable technologies and contract manufacturing services to the biopharmaceutical industry. Our management team has 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.

Our "Try and Take" business model gives maximum flexibility to our customers and provides them with cost-effective manufacturing capabilities.

We are committed to our customers' success in 'speeding medicines to people' by providing them with excellent service and technologies.

Products and Services

Xcellerex Disposable Bioreactor (XDR) is our scaleable, disposable, stir-tank bioreactor (XDR) which operate as stand-alone skid mounted units or integrated 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. XDRs are available in 200, 500 and 1000L working volume, with a 5:1 turn-down operating volume. Xcellerex is operating up to 1000L scale in our cGMP contract manufacturing services group.

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 and down mixing capability, XDMs are available in 100–1000 L working volume scales. Multiple disposable bag configurations are available for all your processing needs.

FlexFactory is Xcellerex's modular biologics manufacturing platform, designed for rapid deployment, flexibility and minimal capital cost, allowing for the postponement of the 'build' decision for cGMP biologics manufacturing. An automated control system and electronic batch record can be integrated or use of legacy systems is possible. The FlexFactory platform allows Xcellerex greater flexibility in responding to our clients' needs for contract manufacturing and also provides a fully integrated 'take-away' technology to enable manufacturing directly. The Flex Factory has been reviewed by FDA, and is being use in cGMP manufacturing at 1000L scale at Xcellerex.

As part of manufacturing services our capabilities range from cell line construction through cGMP manufacturing of biological products including monoclonal antibodies, vaccines, cytokines and other 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 10's of millions of transfectants to find the highest producing cell lines.

Media Optimization: Optimize key media components early in the development stage, reducing the regulatory risks associated with process changes for scale-up to commercial scale manufacturing.

Purification Development: Using high through-put robotics, we can 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. Currently operating at 1000 L in Pilot Plant and cGMP Manufacturing.

Microbial Capacity: 250 L cGMP capacity for yeast and bacteria in operation and available for contract services. Additional capacity coming on line in 2007 at 500 L working volume scale.

170 Locke Drive
Marlborough, MA 01752





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