En Cn Jp

Quality Documents by Product

Repligen facilities operate according to ISO 9001 Quality Management Systems (QMS), with the aim of building quality into every Repligen product.

View by document type

Cell Culture Supplements

KrosFlo^® TFDF^® Systems

KrosFlo^® TFF Systems

OPUS^® Pre-packed Chromatography Columns

Protein A Ligands

Protein A Resins

Spectra/Chrom^® Chromatography Supplies

Spectrum^® Hollow Fiber Filters

TangenX^® TFF Flat Sheet Cassettes

XCell ATF^® Systems

Quality Management Documents

Cell Culture Supplements

Expand All

Safety Data Sheets

LONG^®R³ IGF-I - Freeze-dried - Material Safety Data Sheet

LONG^®R³ IGF-I - Liquid - Material Safety Data Sheet

LONG^®EGF - Freeze-dried - Material Safety Data Sheet

Certificates of Analysis and Quality - Examples

LONG^®R³ IGF-I Certificate of Analysis - Freeze-dried - Example

LONG^®R³ IGF-I Certificate of Analysis - Liquid - Example

LONG^® EGF Certificate of Analysis - Freeze-dried - Example

Quality and Animal-Free Statements

LONG^®R³ IGF-I Quality Statement

LONG^®R³ IGF-I Animal-free Statement

LONG^®EGF Quality Statement

LONG^®EGF Animal-free Statement

Dialysis

Expand All

User Guides

SpectraFlo™ Dynamic Dialysis Systems

Float-A-Lyzer^® G2 Ready-to-use Microdialysis Devices

Micro Float-A-Lyzer^®Ready-to-use Microdialysis Devices

Tube-A-Lyzer^® Dynamic Dialysis System

Spectra/Por^®Biotech Grade Dialysis Membranes: Cellulose Ester (CE), RegeneratedCellulose (RC)

Spectra/Por^®1-7 Standard Grade Regenerated Cellulose Dialysis Membrane

Spectra/Por^®In Vivo Microdialysis Hollow Fibers

Spectra/Gel^® Absorbent

KrosFlo^® KR1 Pump System, Stand Kit

ELISA Kits

Expand All

User Guides

NGL COVID-19 Spike Protein Affinity Ligand ELISA Kit (9444-1)

LONG^®R³ IGF-I ELISA Kit User Guide

ELISA nPA rPA User Guide

ELISA NGL Impact A User Guide

ELISA MabSelect User Guide

Safety Data Sheets

Protein A ELISA Kit for Native and Recombinant Protein A (9000-1)

Reagent A
- English
- Chinese
- Dutch
- French
- German
- Hebrew
- Swedish
Reagent D
- English
- Chinese
- Dutch
- French
- German
- Hebrew
- Swedish

Protein A ELISA Kit for MabSelect SuRe Ligand (9333-1)

Reagent A
- English
- Chinese
- Dutch
- French
- German
- Hebrew
- Swedish
Reagent D
- English
- Chinese
- Dutch
- French
- German
- Hebrew
- Swedish

LONG^®R³ IGF-I ELISA Kit (9547-1)

Reagent D
- English
- Chinese
- Dutch
- French
- German
- Hebrew
- Swedish

Certificates of Analysis and Quality - Examples

LONG^®R³ IGF-I ELISA Kit Certificate of Analysis - Example

Protein A ELISA Kit for the Detection of MabSelect SuRe™ Ligand Certificate of Analysis - Example

Protein A ELISA Kit for Native and rProtein A Certificate of Analysis - Example

KrosFlo^® TFDF^® Systems

Expand All

User Guides

KrosFlo^® TFDF^® Lab System User Guide

KrosFlo^® TFDF^® Lab System Set-up Guide

KrosFlo^® Systems - English

KrosFlo^® Systems - Danish

KrosFlo^® Systems - Dutch

KrosFlo^® Systems - French

KrosFlo^® Systems - German

KrosFlo^® Systems - Italian

KrosFlo^® Systems - Spanish

REACH Statements

KrosFlo^® TFDF^® Lab System

Regulatory Support FIles

KrosFlo^® TFDF^® Lab System and ProConnex^® TFDF^® Flow Path

KrosFlo^® TFF SYSTEMS

Expand All

User Guides

KrosFlo^® Systems - English

KrosFlo^® Systems - Danish

KrosFlo^® Systems - Dutch

KrosFlo^® Systems - French

KrosFlo^® Systems - German

KrosFlo^® Systems - Italian

KrosFlo^® Systems - Spanish

KrosFlo^® KR2i / KMPi TFF Systems with KONDUiT User Guide

KrosFlo^® TFF System - Auxiliary Scale ACSS-20K

KrosFlo^® TFF System - Auxiliary Scale ACSS-60K

KrosFlo^® KR1 Pump System, Stand Kit

KrosFlo^® Digital Pressure Monitor

Ultra Precision Scale

Saw Scale (with MKE-5)

KF Comm 2 Software User Guide

OPUS^® Pre-packed Chromatography Columns

Expand All

User Guides

OPUS^® 5-80R Pre-packed Chromatography Columns User Guide

Uncrating OPUS^® 45-60R Pre-packed Chromatography Columns

Uncrating OPUS^® 80R Pre-packed Chromatography Columns

Unpackaging OPUS^® 10-30 Pre-packed Chromatography Columns

OPUS^® 1.2 – 2.5 Chromatography Columns Pre-packed with CaptivA^® Resin User Guide

OPUS^® RoboColumn^®User Guide

OPUS^® ValiChrom™ User Guide

OPUS^®Pre-packed Chromatography Columns Connection and Priming

Regulatory Support Files

OPUS^® Columns Regulatory Support File

Certificates of Analysis and Quality - Examples

OPUS^® Pre-packed Chromatography Column Certificate of Analysis Pre-GMP - Example

OPUS^® Pre-packed Chromatography Column Certificate of Analysis GMP Run Ready - Example

Quality and Animal-Free Statements

General Quality Statement

BSE and TSE Free Statement

Melamine and BPA Free Statement

Nitrosamine Statement

Protein A Ligands

Expand All

Regulatory Support Files

mC5 - Recombinant Protein A LIgand

Native Recombinant Staphylococcal Protein A Lignad (rSPA) Regulatory Support File

Safety Data Sheets

Recombinant Protein A (mc5, srPA50, rSPA) Material Safety Data Sheet

Native Protein A Material Safety Data Sheet

Certificates of Analysis and Quality - Examples

APB Recombinant Protein A (rPA-APB) Certificate of Analysis - Example

Recombinant Staphylococcal Protein A (rSPA) Certificate of Analysis - Example

Soy Fermented Recombinant Protein A (srPA-50) Certificate of Analysis - Example

Native Protein A Certificate of Analysis - Example

Affinity Resins

Expand All

User Guides

CaptivA^® Protein A Affinity Resin Regulatory Support File

IPA 400HC Protein A Affinity Resin Regulatory Support File

Regulatory Support Files

NGL COVID-19 Spike Protein Affinity Resin

CaptivA^® Protein A Affinity Resin Regulatory Support File

IPA 400HC Protein A Affinity Resin Regulatory Support File

Safety Data Sheets

CaptivA^® Protein A Affinity Resin Material Safety Data Sheet

Immobilized rProtein A (IPA 300S) Material Safety Data Sheet

Immobilized rProtein A (IPA-400HC) Material Safety Data Sheet

Spectra/Chrom^® Chromatography Supplies

Expand All

User Guides

CF-2 Fraction Collector

Model 280 UV Monitor

Spectra/Chrom^® Chart Recorder

IS-95 Interval Sampler

S-3 Solvent Saver System

Spectrum^® Hollow Fiber Filters and Membranes

Expand All

User Guides

Spectrum^®MicroKros and MidiKros Hollow Fiber Modules

Spectrum^®Hollow Fiber Filter Module Preparation

TangenX^® TFF FLAT SHEET CASSETTES

Expand All

User Guides

TangenX^® TFF Cassette Air Integrity Testing Application Note

TangenX^® SIUS^® Gamma Closed TFF Cassette Set-up Guide

TangenX^® SIUS^® Gamma TFF Device User Guide

TangenX^® PRO Cassette User Guide

TangenX^® SIUS^® PD Cassette User Guide

X-Flo76™ User Guide

Disc Membrane User Guide

TangenX^® PRO PD Cassette User Guide

TangenX^® SIUS^® Cassette

EH10236 TangenX^® Hydraulic Pump User Guide

TangenX^® PRO PD Low Holdup Volume (LHV) System User Guide

TangenX^® PRO PD Cassette Holder Compatibility Guide

TangenX^® SIUS^® PD Cassette Holder Compatibility Guide

TangenX^® PRO Cassette Holder Compatibility Guide

TangenX^® SIUS^® Cassette Holder Compatibility Guide

TangenX^® SIUS^® Filter Plate and 4-Bolt Clamp Assembly

TangenX^® SIUS^® PD Filter Plate and 2-Bolt Clamp Assembly User Guide

Safety Data Sheets

TangenX™ PRO Cassette Safety Data Sheet

TangenX™ SIUS Cassette Safety Data Sheet

XCell ATF^® Systems

Expand All

User Guides

XCell ATF^® 1 Device Set-up Guide

XCell™ Lab Controller User Guide

XCell ATF^® 2 Single-use Device Start-up Guide

XCell ATF^® 6 Single-use Device Start-up Guide

XCell ATF^® 10 Single-use Device Start-up Guide

XCell™ C410:V4B Controller

XCell™ C410:V3 Controller

XCell ATF^® Systems Filter Preparation and Autoclave

Certificates of Analysis and Quality - Examples

XCell ATF^® System Certificate of Quality - Example

Quality System Management Documents

Expand All

United States

ISO 9001:2015 Certificate of Registration (Waltham, Marlborough, Billerica, Breda)

ISO9001:2015 Certificate of Registration - US (Rancho Dominguez)

Quality Policy - US

Sweden

ISO 14001:2015 Certificate - Sweden

ISO 9001:2015 Certificate - Sweden

Environmental Policy - Sweden

Quality Policy - Sweden