OEM

Customized Biomaterials
Development & Manufacturing
Living Immunoassay
ExcellenceWerfen is a growing, family-owned,
innovative company founded in 1966
in Barcelona, Spain.
Our OEM Technology Center has
consolidated experience in research,development and manufacturing ofcustomized assays and biomaterials.
We offer end-to-end solutions for
the IVD industry with the mostinnovative capabilities to enhancecompetitiveness and time-to-market.
Our mission is to become your partnerof choice as a center of excellence inproviding innovative end-to-end OEMsolutions (products & services) to IVDcompanies.

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Customized Biomaterials. Development & Manufacturing

Innovation

Operational Excellence

Commitment

Our OEM Technology Center ranks
among the top centers of excellence
for immunoassay and biomaterial
development and manufacturing in theindustry. Our focus on technologicaladvances ensures our customers
access to state-of-the-art R&D andmanufacturing capabilities. Werfen’s
innovative nature is strengthened throughclose relationships with prestigious
universities and biotechnology research
centers around the world.

Our key strength is the combinationof the ongoing effort to improve ourorganizational processes, products andservices with the Werfen mindset thatembraces principles and tools to createa sustainable partnership with ourcustomers and employees.
Our Quality System is certified to ISO
13485:2016 / EN ISO 13485:2016 as well
as MDSAP.

Customers and patients benefit from theefficiency of a talented global team ofqualified and specialized professionals
who lend their enthusiasm, dedicationand energy on a daily basis in order toprovide high quality products & services.

You can rely on the expertise andcapabilities of our R&D and Operations
teams to develop and manufacture
customized Biomaterials> 200
Biomaterials
developed> 10 different
clinical fields

Use oncommercial
WW assays

What canCustomized
Biomaterials
offer you?

Antibody & Antigen
de novo: Design, Developmentand Manufacturing

Antibody & Antigen production
process: Adaptation, Optimization,
Scale-up and Manufacturing

Antibody & Antigen
Scale-up andManufacturing

Develop from inception of a biomaterial for diagnostics, from new
antibody or antigen selection to routine production processes,
adapted to your operational demands.

Improve the production yield and/or performance of yourbiomaterial of interest.

Optimize your daily operations and meet demand increases
thanks to our biomaterial production capabilities.

We can design the wholeprocess for generation ofan antibody or antigen(native or recombinant)

Design1

The most appropriate
expression systems arescreened to produce thebiomaterial that you need

Screening

Our biomaterial purification& characterization
processes are optimized
for diagnostic intended use

The best scale-up
approach for youroperational needs

Purification & Characterization

De novo:

State-of-art production
facilities that cover yoursupply needs

Process Optimization & Scale-up

ManufacturingDesign, Development and Manufacturing

2Production process:
Adaptation, Optimization, Scale-Up and Manufacturing

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Routine ManufacturingDesign
Based on your needs we can design the entire
process for generating a new recombinant
antibody.
If you already have an antibody in mind, we canmodify it to meet your needs: improving affinity,
sequence modification, tag addition, etc. Our
expertise in recombinant antibodies extends
to different antibody formats. If your needs arerelated to a specific antigen, we can also design
the entire generation and production process forthis new recombinant antigen or we can modify
an existing one by improving affinity, sequencemodification, tag addition, improving stability,
among others. In addition, we have in-housebioinformatics protein modelling to simulate how
the biomateiral could be affected in differentconditions.
One of the major challenges for an IVD company
is to obtain IgM-positive plasma and serum tobe used as controls or calibrators for diagnostic
assays since IgMs have a short life, disappearing
earlier than IgGs. In order to overcome thischallenge, our customized biomaterials team hasdeveloped a process to generate a recombinant
IgM antibody that can be used as a calibrator orcontrol for a diagnostic assay.

Figure 1. Summary of the process of generating an IgM antibody to be used as a calibrator or control

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Customized Biomaterials. Development & Manufacturing

Purification &Characterization
Our extraction & purification platforms are
optimized taking in consideration that thepurified antibody/protein will be used in adiagnostic assay. Based on your needs, we canperform peptide mapping analysis, evaluate
state of aggregation, as well as determining
your sample molecular weight distribution,
purity, charge variants and glycosylation
patterns among others.

uV5.0

rIgG + tagrIgG
Hybridoma IgG

10.0

15.0

20.0

25.0

30.0

Figure 2. Example of Peptide Mapping (PEM).

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Customized Biomaterials. Development & Manufacturing

35.0

40.0

45.0

50.0

55.0

60.0

65.0

70.0

75.0

80.0minMoreover, functional tests for the requested
biomaterial can be provided. These tests
include affinity constants and interaction
kinetics by biolayer interferogram andsurface plasmon resonance as well as
diagnostic assays.
Apart from Bio-Layer interferometry andsurface plasmon resonance, our biomaterials
can benefit from R&D assay development toassess the functionality of a new biomaterial
in latex based or chemiluminiscence based
immunoassays.

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Customized Biomaterials. Development & Manufacturing

Our biomaterials team works towards
the goal of streamlining biomaterials
production so as to optimize and scale up
the production process for a biomaterial for
diagnostics. In figure 4 you can see a coupleof examples of the results obtained after themanufacturing process optimization andscale-up to bioreactior of a recombinant viral
antigen (virus like particles) to be used for adiagnostic assay to detect antibodies.

Figure 4. Example of a manufacturing processs optimizationand scale-up: In the graph on left Size Exclusion Chromatography for the analysis of the recombinant antigens obtained withcurent and optimized manufacturing proceprocess and a electronic microscopy image of the recombiant antigens obtained
after the manufacturing process optimization and scale-up.

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Customized Biomaterials. Development & Manufacturing

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Optimized manufacturing process for recombinant Antigen
Current manufacturing process for recombinant Antigen
Injection

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With Werfen’s Customized
Biomaterials you can get access toUpstream
Capabilities

Biomaterial Sources
Monoclonal
Antibodies
Hybridorna Cell
Lines

Polyclonal
Antibodies

NativeAntigens

RecombinantProteins

GoatBacteria

MicrobialStrainsRabbit
Mammalian celllines (recAb)

Downstream
Capabilities

Guinea Pig

Viruses

Human Sera

Baculovirus
Expression
SystemYeast

Nutrients andbyproducts analysis
Cell population
analysis
Cell culture aminoacidanalysis

Protein Characterization

Protein Extraction

Physicochemical Analysis

Functional Analysis

UV Spectrophotometry

Surface plasmon resonanceCentrifugation &Ultracentrifugation

Chromatography (Affinity, IEX,SEC, HIC, Multimodal)
Protein refolding

Customized Biomaterials. Development & Manufacturing

Mammalian CellLines

Viable and total cells
concentration byautomatic cell counter

Protein Purification

Microfiltration & Ultrafiltration

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In-Process Controls

Electrophoresis
Isoelectric point determination
Ion exchange chromatography
Glycosytation pattern

Bio-Layer Interferometry
Enzyme-Linked
Immunosorbent Assay (ELISA)

Peptide mapping
Protein amino acid analysis

Chemical modification

Surface hydrophobicity

Labeling

DSF (differential scanningfluorimetry)

Chemilluminescent
Immunoassay
Latex based immunoassay

3100-9803 R02 FEBRUARY-2024

Living Immunoassay
Excellence

Av. Can Montcau, 708186 Lliçà d’Amunt
Barcelona, Spain
Phone: +34-93-860-9000
werfen.com/oem