captureselect™ technology: introducing one-step ... · the sds-page and fsh wb clearly...

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Pipeline of Affinity Products Platform for Purification of Biologicals CaptureSelect™ FSH Affinity Resin recognizes only intact Follicle Stimulating Hormone, offering the possibility for a one-step capture with high yield and purity. (LEFT) CaptureSelect™ FSH resin was used to purify rFSH from feedstock. Elution (>90%) was performed with 20 mM Tris, 2M MgCl 2 pH 7.4 (EC-1), and remaining material was stripped with PBS pH 2.0 (EC-2). The SDS-PAGE and FSH WB clearly demonstrate the specificity. Next the resin was able to discriminate between intact and just the alpha or beta strain (data not shown) VIIISelect is a resin designed for the production of recombinant b-domain deleted Factor VIII. VIIISelect allows for a simple purification of Factor VIII from mammalian feedstock with high yield and attained activity. (RIGHT) Silver chain gel showing that the eluate using VIIISelect (lanes 6-8)is comparable to the reference standard and that HCP’s present in an intermediate step (lanes 9-11) are removed. VIIISelect is marketed and sold by GE Healthcare. CaptureSelect™ Product Overview CaptureSelect™ purification and affinity separation products are developed for the discovery and manufacturing of therapeutic proteins, including antibodies and antibody fragments. These products enable a reduced time to market, increased purity and yield and an overall lower cost of goods for biopharmaceutical development. Technology Platform CaptureSelect™ technology presents a unique platform for development of product and process specific affinity solutions. Product Portfolio Range M: BenchMark Protein ladder 2. Peri fraction of E.coli 4. Flow through fraction anti LC-kappa anti IgG-CH1 - high purity in one step - no interference of free light chains M 1 2 3 4 5 Load Non-Bound Elution CH1 VH CH1 VH 2.0 3.0 4.0 5.0 6.0 7.0 0.0 5.0 10.0 15.0 ml 4 5 CL VL CL VL CL VL CL VL 1. human polyclonal Fab kappa 3. Peri spiked with 0.4 mg Fab/ml 5. Elution fraction C L V L C L V L C L V L C L V L CH1 VH CH1 VH Fab free LC - Separation of intact human IgG Fab fragments from free light chains present in feed stock materials Mix CaptureSelect™ Affinity Resins: purification of human Fab fragments lifetechnologies.com/captureselect Life Technologies has developed a large number of products (in various stages of development) for applications ranging from detection to bench scale purification, all the way up to cGMP manufacturing of biological products. A Life Technologies Company Unique products for the highly efficient direct capture purification of various biomolecules such as antibodies and antibody fragments, fusion proteins (Fc and albumin) and biosimilar hormones. Custom service for the development of product and process specific affinity solutions. Ready-to-use resins suitable for small scale purification - Antibody Toolbox: purify any antibody format from any species using our diverse product portfolio - Protein Purification: one-step solution for the purification of non-antibody biopharmaceuticals - C-tag: smallest affinity tag system (4 amino acid recognition) available on the market, offering high selectivity, affinity and a variety of elution conditions. Companion products for further characterization and quantitation of biomolecules HPLC columns: Prepacked POROS® CaptureSelect™ Affinity Columns for fast and easy quantitation. Ligand Conjugates: Biotinylated CaptureSelect™ ligands for use in analytical assays, including Western blot and label-free systems. CaptureSelect™ affinity resins drive a simplified manufacturing processes for a large variety of biopharmaceutical compounds, offering: Increased selectivity - High purity in single step / feed stock independent Mild elution conditions - Retaining biological activity of target Reduction in the number of process steps - Helping increase yields, reduce costs Efficient clearance of HCP, DNA, virus - High selectivity in capture step Frank Detmers, Remko Clasen, Ingeborg van Gemeren, Life Technologies, 5791 Van Allen Way, Carlsbad, CA, 92008 CaptureSelect™ Technology: Introducing One-Step Selectivity in the Purification of Biological Products CaptureSelect Affinity Products for Purification of: Therapeutic proteins (non-mAb) Antibody Types Vaccines & Viruses Stage 5: Candidates Antithrombin III Fibrinogen Transferrin Von Willebrand Factor ApoA IgA Improved IgG-Fc Stage 4: Lead Selection Prothrombin Exotoxin A (PE) IgG-CH2 Rotavirus Stage 3: Matrix Testing Insulin ApoH VH3 Free LC-kappa Stage 2: Library Screening C1-Inhibitor Interferon alpha/beta, hIL2 GM-CSF, hCG, Protein C FV, FX, FXI, FXII, FXIII, FH Free LC-lambda Stage 1: Immunization tPA For research use only. Not for use in diagnostic procedures. © Copyright 2013, Life Technologies. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. All other trademarks are the sole property of their respective owners. Life Technologies • 5791 Van Allen Way • Carlsbad, CA 92008 • www.lifetechnologies.com

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Pipeline of Affinity Products

Platform for Purification of Biologicals

CaptureSelect™ FSH Affinity Resin recognizes only intact Follicle StimulatingHormone, offering the possibility for a one-step capture with high yield and purity.

(LEFT) CaptureSelect™ FSH resin was used to purify rFSH from feedstock. Elution (>90%) was performed with 20 mM Tris, 2M MgCl2 pH 7.4 (EC-1), and remaining material was stripped with PBS pH 2.0 (EC-2). The SDS-PAGE and FSH WB clearly demonstrate the specificity. Next the resin was able to discriminate between intact and just the alpha or beta strain (data not shown)

VIIISelect is a resin designed for theproduction of recombinant b-domaindeleted Factor VIII. VIIISelect allows for asimple purification of Factor VIII frommammalian feedstock with high yield andattained activity.

(RIGHT) Silver chain gel showing that the eluate using VIIISelect (lanes 6-8)is comparable to the reference standard and that HCP’s present in an intermediate step (lanes 9-11) are removed.

VIIISelect is marketed and sold by GE Healthcare.

CaptureSelect™ Product Overview

CaptureSelect™ purification and affinity separation products are developed for thediscovery and manufacturing of therapeutic proteins, including antibodies andantibody fragments. These products enable a reduced time to market, increasedpurity and yield and an overall lower cost of goods for biopharmaceuticaldevelopment.

Technology Platform

CaptureSelect™ technology presents a unique platform for development of productand process specific affinity solutions.

Product Portfolio Range

M: BenchMark Protein ladder2. Peri fraction of E.coli4. Flow through fraction

anti LC-kappa anti IgG-CH1- high purity in one step - no interference of free light chains

M 1 2 3 4 5 Load Non-Bound Elution

CH1

VH

CH1

VH

2.0

3.0

4.0

5.0

6.0

7.0

0.0 5.0 10.0 15.0 ml

4 5

CL

VL

CL

VL

CL

VL

CL

VL

1. human polyclonal Fab kappa3. Peri spiked with 0.4 mg Fab/ml5. Elution fraction

CL

VL

CL

VL

CL

VL

CL

VLCH1

VH

CH1

VH

Fab

free LC

- Separation of intact human IgG Fab fragments fromfree light chains present in feed stock materials

Mix

CaptureSelect™ Affinity Resins: purification of human Fab fragments

lifetechnologies.com/captureselect

Life Technologies has developed a large number of products (in various stages ofdevelopment) for applications ranging from detection to bench scale purification, allthe way up to cGMP manufacturing of biological products.

A Life Technologies Company

Unique products for the highly efficient direct capturepurification of various biomolecules such as antibodiesand antibody fragments, fusion proteins (Fc andalbumin) and biosimilar hormones.

Custom service for the development of productand process specific affinity solutions.

Ready-to-use resins suitable for small scale purification- Antibody Toolbox: purify any antibody format from

any species using our diverse product portfolio- Protein Purification: one-step solution for the

purification of non-antibody biopharmaceuticals- C-tag: smallest affinity tag system (4 amino acid

recognition) available on the market, offering highselectivity, affinity and a variety of elution conditions.

Companion products for further characterization andquantitation of biomolecules• HPLC columns: Prepacked POROS®

CaptureSelect™ Affinity Columns for fast andeasy quantitation.

• Ligand Conjugates: Biotinylated CaptureSelect™ligands for use in analytical assays, includingWestern blot and label-free systems.

CaptureSelect™ affinity resins drive a simplified manufacturing processes for a large variety of biopharmaceutical compounds, offering:

Increased selectivity- High purity in single step / feed stock independent

Mild elution conditions- Retaining biological activity of target

Reduction in the number of process steps - Helping increase yields, reduce costs

Efficient clearance of HCP, DNA, virus - High selectivity in capture step

Frank Detmers, Remko Clasen, Ingeborg van Gemeren, Life Technologies, 5791 Van Allen Way, Carlsbad, CA, 92008

CaptureSelect™ Technology: Introducing One-Step Selectivity in the Purification of Biological Products

CaptureSelect™ Affinity Products for Purification of:

Therapeutic proteins (non-mAb)

Antibody Types Vaccines & Viruses

Stage 5: Candidates

Antithrombin IIIFibrinogenTransferrin

Von Willebrand FactorApoA

IgAImproved IgG-Fc

Stage 4: Lead Selection

ProthrombinExotoxin A (PE)

IgG-CH2 Rotavirus

Stage 3: Matrix Testing

InsulinApoH

VH3Free LC-kappa

Stage 2: Library Screening

C1-InhibitorInterferon alpha/beta, hIL2GM-CSF, hCG, Protein CFV, FX, FXI, FXII, FXIII, FH

Free LC-lambda

Stage 1:Immunization

tPA

For research use only. Not for use in diagnostic procedures. © Copyright 2013, Life Technologies. All rights reserved. The trademarksmentioned herein are the property of Life Technologies Corporation or their respective owners. All other trademarks are the soleproperty of their respective owners.

Life Technologies • 5791 Van Allen Way • Carlsbad, CA 92008 • www.lifetechnologies.com