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Repligen

Biotechnology company From Wikipedia, the free encyclopedia

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Repligen Corporation is a global life sciences company devoted to the development and commercialization of innovative bioprocessing technologies and systems that enable efficiencies in the process of manufacturing biological drugs.2025 The company is based in Waltham, Massachusetts,2014 and was incorporated in Delaware in 1981.[2] A public company, Repligen is listed on the NASDAQ exchange under the symbol RGEN.[3] As of 2025, Repligen employs over 1,900 employees globally and serves primarily biopharmaceutical drug developers and contract development and manufacturing organizations (CDMOs) worldwide.

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Business model

Before 2012, Repligen maintained dual capabilities in developing pharmaceutical therapeutics (drug discovery and development) and the development of materials supporting biological drug manufacture (bioprocessing business).[4] A decision was made in 2012 to focus on the bioprocessing business and reduce research and development expenditures.[5] As of 2024, Repligen's product portfolio includes filtration and fluid management, Chromatography, process analytics and proteins, serving a wide range of biologics including monoclonal antibodies (mAbs), Antibody–drug conjugates (ADCs), bispecific antibodies, fusion proteins, mRNA, and cell and gene therapies.

Sales

Repligen employs a direct sales model to users of its products in the United States, with some sales through intermediaries in "certain foreign markets".[6] Repligen now serves a global customer base with significant growth in North America, Europe, and Asia-Pacific.

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Facilities

Repligen's company headquarters are housed together with its manufacturing facility in Waltham, Massachusetts.[7]

Headquartered at Waltham, Massachusetts, Repligen operates across 22 sites globally in the United States, Europe, and Asia Pacific. Growth factor products and the native form of Protein A and recombinant Protein A are manufactured in Sweden; assembly of the OPUS chromatography product line is done in the United States.[8]

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Corporate history and governance

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Alexander Rich was a co-founder of Repligen and served as Chairman Emeritus[9] of Repligen's board of directors. Rich had been a member of the Board since 1981.[10] Paul Schimmel is also a co-founder of Repligen, and he is the Ernest and Jean Hahn Professor at The Skaggs Institute for Chemical Biology at The Scripps Research Institute. He used to be the John D. and Catherine T. MacArthur Professor of Biochemistry and Biophysics in the Department of Biology at MIT. Tony J. Hunt, who actively serves as executive chairman for the board, was the company's President and Chief Executive Officer from 2015 to 2024.

As of 2024, the company's President and Chief Executive Officer is Olivier Loeillot.

Acquisitions and in-licensing

In 2010, Repligen licensed technology from BioFlash which it subsequently incorporated into the OPUS line of pre-packed chromatography columns.[11]

In 2011, Repligen acquired bioproduction assets from Novozymes, which doubled the company's bioprocessing capabilities.[4]

In 2014, Repligen acquired Alternating Tangential Flow (ATF) system from Refine Technology.[12]

In December 2016, Repligen acquired TangenX.[13]

in June 2017, Spectrum Laboratories Inc. was acquired.[14]

In May 2019, C Technologies was acquired.[15]

In 2020, ARTeSYN Biosolutions wad acquired, expanding on the company's filtration an chromatography systems strategy.[16]

In June 2021, Polymem S.A. was acquired.[17]

In September 2021, Avitide, Inc. was acquired.[18]

In December 2021, BioFlex Solutions was acquired.[19]

In April 2023, Flexbiosys Inc. was acquired.[20]

In September 2023, Repligen acquired magnetic mixer manufacturer, Metenova.[21]

At the end of 2024, Tantti Laboratory Inc. was acquired.[22]

In 2025, Repligen acquired four process analytics technologies assets from chemical analysis tech firm 908 Devices.[23]

Divestments and out-licensing

In 2008, an agreement was struck to divest certain intellectual property rights to Bristol-Myers Squibb around the drug Orencia in exchange for ongoing royalty payments through the end of 2013.[4]

At the end of 2012, Repligen out-licensed its spinal muscular atrophy program, in particular the small molecule candidate drug RG3039, to Pfizer.[4] This divestment included licensing rights to two patents to Pfizer.[8][24][25]

At the start of 2014, the company out-licensed its Friedreich's ataxia program, including a library of histone deacetylase inhibitor compounds, to BioMarin Pharmaceutical for US$2,000,000 and future milestone and royalty payments.[2][26]

Terminations and moth-balling

Development of an imaging agent, designated RG1068, based on a synthetic human hormone was halted in 2012 following a request by the USFDA for additional safety and efficacy data beyond that provided in a New Drug Application (NDA) submission; a Marketing Authorization Application had been submitted in parallel to the EMA.[2]

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Products and services

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Repligen was a major supplier of Protein A, both native and recombinant forms, to the pharmaceutical industry.[4] In 2010-2013, Protein A accounted for the majority of the company's product sales.[11] The company also provides growth factors to increase the productivity of cell-based bioproduction, multiple alternating tangential flow (ATF) systems, and a line (OPUS) of chromatography columns scaled to manufacture of product for testing in clinical trials.[4]

Today, the company's suite of offerings has been diversified by its many acquisitions and partnerships. In downstream bioprocessing, Repligen offers tangential flow filtration systems (Cross-flow filtration), flat sheet cassettes, hollow fiber filters, single-use components, assemblies, mixers, chromatography systems, pre-packed columns, and resins. Within upstream bioprocessing they offer alternating tangential flow filtration systems (ATF), tangential flow depth filtration systems (TFDF), tangential flow filtration systems and cell culture supplements. Across the entire bioproduction workflow there are Process analytical technology (PAT) devices offered as standalone solutions or directly integrated onto filtration systems.

Some Repligen products include, but are not limited to:

  • AVIPure® AAV Affinity Resins
  • CTech™ SoloVPE® PLUS System
  • CTech™ FlowVPE® PLUS System
  • Fluid Management
  • KRM® Chromatography System
  • KrosFlo® TFF Systems
  • MAVEN® System
  • MAVERICK® System
  • Metenova®
  • OPUS® Pre-Packed Columns
  • ProConnex® Flow Paths
  • ProConnex® MixOne RG-X
  • REBEL® Smart® System
  • TangenX® Cassettes
  • XCell® ATF Systems

Launches and Innovations

In 2023, Repligen launched the KrosFlo® RS 10 TFF system, introducing the first laboratory scale tangential flow filtration system built specifically for Biomanufacturing with adherence to Current Good Manufacturing Practices (cGMP). During the same year, the company released a self-contained, holder less TFF device called the TangenX® SC.

In 2025, the company launched the CTech™ SoloVPE PLUS System, their UV-based Variable Pathlength Technology system.[27]

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Notes

References

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