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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.

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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

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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

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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

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User Guides

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

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User Guides

KrosFlo^® TFDF^® Lab System User Guide

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

REACH Statements

KrosFlo^® TFDF^® Lab System

Regulatory Support FIles

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

KrosFlo^® TFF SYSTEMS

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User Guides

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

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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

Protein A Ligands

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Regulatory Support Files

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

Safety Data Sheets

Recombinant Protein A (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

Protein A Resins

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User Guides

CaptivA^® Protein A Affinity Resin Regulatory Support File

IPA 400HC Protein A Affinity Resin Regulatory Support File

Regulatory Support Files

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

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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

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User Guides

Spectrum^®MicroKros and MidiKros Hollow Fiber Modules

Spectrum^®Hollow Fiber Filter Module Preparation

TangenX^® TFF FLAT SHEET CASSETTES

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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

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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™ C24:V3 Controller User Guide

XCell ATF^® System with C410:V4B Controller

XCell ATF^® System with 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

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United States

ISO9001:2015 Certificate of Registration - US (Waltham)

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