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Repligen Launches Single-Use XCell™ ATF System for Bioprocess Intensification

RGEN

  • Complements Stainless Steel ATF Technology with Innovative Single-Use Format
  • Improves Ease of Use for Biopharmaceutical Manufacturing Customers
  • Offers Equivalent High Performance to Stainless Steel XCell™ ATF With Faster Implementation

WALTHAM, Mass., Oct. 05, 2016 (GLOBE NEWSWIRE) -- Repligen Corporation (NASDAQ:RGEN), a life sciences company focused on bioprocessing technology leadership, today announced the commercial launch of its single-use version of XCell™ ATF, a proprietary cell retention system used by biologic drug manufacturers to intensify cell culture and improve the efficiency and productivity of upstream processes. This innovative new single-use format, which will be offered alongside the existing stainless steel line, significantly reduces implementation time and improves overall ease of use for Repligen’s biopharmaceutical manufacturing customers. The new XCell ATF format aligns with single-use and continuous processing workflows that biomanufacturers are increasingly adopting for their flexibility, convenience and cost-saving advantages.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/a2bd701b-d6a4-4df1-8875-d03e770bd107

The single-use XCell ATF will be formally introduced at Biotech Week Boston, taking place October 4-7 at the Boston Convention and Exhibition Center. Repligen will initially offer the single-use version of XCell ATF in sizes suitable for lab-scale and production-scale biopharmaceutical manufacturing. Additional information and features of this technology can be found on Repligen's website.

Christine Gebski, Vice President Product Management and Field Applications said, “We expect the availability of XCell ATF technology in a convenient, gamma-sterilized, single-use format to drive increased evaluation and penetration of this perfusion tool in the marketplace. In beta site evaluations, the single-use format reduced implementation time by over 80% while delivering consistent high performance, equivalent to the stainless steel format.”

Tony J. Hunt, President and Chief Executive Officer said, “Since we acquired the ATF technology in 2014, the ATF product group has been a strong driver of growth for the Company. With this launch, Repligen is enabling increased implementation of perfusion-based systems in upstream continuous processing. As we extend the XCell ATF line to align with single-use workflows, we continue to deliver products that improve process economics and efficiencies for our customers.”

About the XCell™ ATF System
The XCell™ ATF System is a filtration device that attaches to a bioreactor and is used by many of the world's largest biopharmaceutical companies and contract manufacturing organizations to improve productivity during the cell culture step of biomanufacturing. The XCell ATF System routinely increases cell densities to 2- or 3-times the levels achieved by standard batch processes. As a result, product yield is increased which improves facility utilization and can reduce the size of bioreactor required to manufacture a given volume of biologic drug product.

The XCell ATF System is available in a range of sizes from lab-scale through to commercial manufacturing in both stainless steel and single-use formats. Repligen is initially offering the single-use format device in two sizes: the XCell ATF 2 (lab-scale) and the XCell ATF 6 (production-scale).

About Repligen Corporation
Repligen Corporation (NASDAQ:RGEN) is a bioprocessing company focused on the development, manufacture and commercialization of highly innovative products used to manufacture biologic drugs. Our bioprocessing products are sold to major life sciences companies, biopharmaceutical development companies and contract manufacturing organizations worldwide. We are the leading manufacturer of Protein A affinity ligands, a critical component of Protein A resins that are used to separate and purify monoclonal antibody-based therapeutics. In upstream processes, our XCell™ ATF systems and cell culture growth factors are used to accelerate and increase product yield during the fermentation stage of biologic drug manufacturing. In downstream processes, we developed and market our innovative line of OPUS® chromatography columns that we deliver pre-packed with our customers’ choice of resin for their bench-scale through clinical production-scale purification needs. Repligen’s corporate headquarters are in Waltham, MA (USA) and our manufacturing facilities are located in Waltham, MA, Lund, Sweden and Weingarten, Germany.

The following constitutes a “Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that statements in this press release which are not strictly historical statements, constitute forward-looking statements, including, without limitation, express or implied statements regarding current or future financial performance, management’s strategy, plans and objectives for future operations, product development and sales, the success of the XCell™ ATF product line and other statements identified by words like “expect,” “may,” “will,” or “could” and similar expressions. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our ability to develop and commercialize products and the market acceptance of our products, including the XCell™ ATF System; reduced demand for our products that adversely impacts our future operations and financial condition; and other risks detailed in Repligen’s most recent Annual Report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements. These forward looking statements reflect management’s current views and Repligen does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.  

Repligen's Single-Use XCell(TM) ATF Filtration Device
Repligen's single-use version of its XCell™ ATF system for bioprocess intensification complements the Company's stainless steel XCell ATF line. The single-use format aligns with continuous processing workflows, offering ease of use and faster implementation with equivalent performance to the stainless steel line.


Repligen Contact: Sondra S. Newman Senior Director Investor Relations (781) 419-1881

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