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Operations

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. Complete Regulatory Support Files are provided to support customer filings.

See selected quality documentS

Multi-site manufacturing

Waltham, Massachusetts, USA - HEADQUARTERS

Repligen manufactures products in facilities covering 80,000 square feet, including manufacturing, quality control and inventory areas, and clean room suites.

  • ISO 9001:2015 certified facility
  • ISO Class 8 and 7 manufacturing clean rooms
  • Products manufactured: OPUS® Columns, XCell™ ATF Systems, ELISA Kits, Protein A Resins, Protein A Ligands

Rancho Dominguez, CA, USA

Repligen manufactures products in facilities covering 56,000 square feet, including manufacturing, quality control and inventory areas, and clean room suites.

  • ISO 9001:2015 certified facility
  • Products manufactured: Hollow fiber membranes, Hollow fiber filters, KrosFlo® TFF Systems, Dialysis products

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, and clean room suites. 

  • ISO 9001:2015 certified facility based on EU GMP
  • ISO 14001:2015 certified facility
  • Products manufactured: Protein A Ligands, Cell culture supplements

Ravensburg, Germany

Repligen GmbH manufactures products in facilities covering a total area of 12,281 square feet.

  • ISO 9001:2015
  • Products manufactured: OPUS® Columns, XCell™ ATF Systems

Marlborough, MA, USA

Repligen manufactures products in facilities covering a total area of 63,000 square feet.

  • Products manufactured: TangenX® flat sheet cassettes and membranes, KrosFlo® TFF Systems

Irving, TX, USA

Repligen manufactures products in facilities covering a total area of 22,000 square feet.

  • ISO 13485:2016
  • Medical Device Directive 93/42/EEC certified 
  • Products manufactured: Operating room disposables