On-Demand GMP CMO Capacity through Sequential Cascade BioManufacturing

Introduction

Production capacity for conventional contract biomanufacturing platforms is typically booked months or years in advance. Once booked, the addition of capacity to an existing facility is a significant undertaking. The Xcellerex FlexFactory CMO configuration changes this by using novel disposables technology in a series of modular, individually isolated process steps, which in effect, multiplies the effective capacity of the Xcellerex contract manufacturing plant. (See Figures 1 and 2). Separate modules exist for inoculation, production, harvest, concentration and filtration, purification, and bulk filling. Incremental capacity can be added when required.

Figure 1 & 2

The only practical time constraint for FlexFactory CMO customers is the completion of necessary tech transfer or process development steps before commencement of manufacturing, if required. For companies requiring several batches of the same drug protein, or single batches of different drugs, the Xcellerex platform provides rapid access to manufacturing capacity.

Capabilities

The Xcellerex FlexFactory contract manufacturing operation offers cGMP pre-clinical and clinical manufacturing up to 1,000 liters of working volume. A wide range of cell lines including CHO, hybridoma, human, and insect cells have been grown in the Xcellerex Disposable Reactor (XDR), and processed in the FlexFactory. Batch, batch-fed, and large-scale perfusion operations are all supported.

The Xcellerex operation is located in a 60,000 sq. ft. facility in Massachusetts, managed and operated by a seasoned team of biopharm industry professionals, each of whom brings more than 20 years of bioprocessing operating management or bioprocessing equipment design experience.

For organizations that need to optimize cell productivity before moving to production, Xcellerex offers PDMax, a high throughput screening platform that offers a unique process development capability. Hundreds of millions of cells can be transfected and the best producers identified. By using factorial 'design of experiments,' cloning, amplification, and high throughput media improvement techniques developed by Xcellerex, protein production increases of 400% or more are achievable in just a few months.

Disposables Based Manufacturing

Disposable manufacturing equipment is used within the FlexFactory manufacturing modules to eliminate the need for expensive and time-consuming cleaning and sterilization, while also dramatically reducing the risk of cross-contamination.

Quality and Compliance

Through the application of innovative technologies and equipment, built on a culture of continuous improvement, Xcellerex designs quality and robustness into every process. Rigorous quality principles are applied to every operation and product, whether a product is in initial clinical trials or nearing commercial product launch. The Xcellerex "Quality by Design" matrix provides the level of compliance specified by the client.

Company info

Xcellerex, Inc.,

170 Locke Drive

Marlbourough, MA 01752

Tel: 508.480.9235

Fax: 508.480.9238

Website: www.xcellerex.com