Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system.  We focus on the timely delivery of high quality, consistent and robust products, and ensuring business continuity for our customers.

Waltham, Massachusetts, USA

Repligen manufactures products in facilities covering 76,000 square feet, including manufacturing, quality control and inventory areas, as well as clean room suites.

  • ISO 9001:2008 certified facility
  • ISO Class 8 and 7 manufacturing clean rooms


Lund, Sweden

Repligen Sweden manufactures products in facilities covering a total area of 45,000 square feet, with large- and small-scale production capabilities based on 5000 L and 50 L fermentation capacities, as well as clean room suites.

  • ISO 9001:2015 certified facility based on EU GMP
  • ISO 14001:2015 certified facility

Weingarten, Germany

Repligen GmbH manufactures pre-packed chromatography columns in facilities covering 4,600 square feet, including manufacturing, quality control and inventory areas, as well as a clean room suite.

  • ISO 9001:2008 certified facility
  • ISO Class 7 manufacturing clean room


Shrewsbury, Massachusetts, USA

Repligen manufactures TangenX™ products in facilities covering 12,000 square feet, including membrane and cassette manufacturing, quality control and inventory area. TangenX™ products are manufactured in accordance with the principles of cGMP.

See selected QUALITY documents

Regulatory support files are provided to support customer filings.

regulatory support files

The Repligen facility in Sweden is certified under the  ISO 14001 Environmental Management System.

environmental policy document

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