OEM

Werfen, your OEM partner of choiceWerfen can assure IVD companies the development and supply of assays thatcover their demand needs continuously and reliably, securing their operations,through our state-of-the-art development and manufacturing capabilities.

Center of Excellence for diagnostic Assays and Biomaterials
Werfen strive to meet the highest standards of innovation and quality in the
research, development and manufacturing of assay and biomaterial solutions
for the IVD industry, with the ultimate goal of promoting greater laboratory
efficiency and better clinical outcomes for patients.

Our development achievements

Operational Excellence - continuous improvement ofprocesses, products and services
Comprehensive process management approach in order to offer
competitive solutions in terms of time to market, critical chain project
management and efficiency.
Production under GMP procedures and lean manufacturing
ISO 8 classified areas for production and filling
Extensive manufacturing scale-up capabilities
Our Manufacturing capabilities>600 References inmanufacturing>150 Million diagnostic tests
manufactured every year

> 85

chemiluminescenceassays> 50		

latex
assays>160 Liters of chemiluminescent
microparticles per batch>300 Liters of latex reagents
per batch>500 Liters of buffer per batch> 200

biomaterials

Experience with> 110

analyzers

Customized Assay

5S methodology implemented in all production areas

Our Filling & Packaging capabilities

Living Immunoassay
Excellence

10 automated liquid filling lines
3 lyophilizers and>50,000 lyophilized vials per batch
Labelling automated visioninspection system>8 million vials filled per year
>1.4 million kits packed per year

3100-9769 R05 SEPTEMBER-2021

Consistently rated as a top-quality partner for OEM solutions

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

Development & Manufacturing
Living Immunoassay
Excellence

OUR
CUSTOMIZEDASSAY
SOLUTIONSCUSTOMIZED DIAGNOSTIC ASSAY
SOLUTIONS FOR YOUR AUTOMATED
PLATFORMS

LONG-TERMPARTNERSHIP

Extensive and proven experience onImmunoassays, most notably using chemiluminescence and turbidimetry technologies, fora variety of automated platforms

Fully committed to building
mutually beneficial longterm relationships with ourpartners in the IVD Industry

THE MOST SUITABLE
BIOMATERIAL FOR
YOUR ASSAY

END-TO-END ASSAY LIFECYCLESERVICES IN ONE PLACE

Design, development andmanufacture of the biomaterial that perfectly suits yourfinal diagnostic assay

DESIGN,FEASIBILITY AND
DEVELOPMENT
OF ASSAYS

TIME TO MARKETIS KEY

Providing solutions from the early stages of productdevelopment right through to product manufacturing,
including high value-added services such as clinical studies,worldwide registration and on-market product support

Customized assay development
solutions, comprising the designof the assay, feasibility studies
with the reagent formulation andfull development

CONTRACTMANUFACTURING

Bringing your assay to market rapidly thanks to integrated
project management for optimized development time anddedicated product transfer from R&D to manufacturing toensure speed, efficiency and reliability

Manufacturing adapted toyour specific needs, fromsupplying bulk reagents totailor-made kit assemblyand packaging services

GLOBALPRESENCE

Extensive experiencein clinical studies andregulatory affairs, with an
in-depth knowledge of therequirements of each market

Continuous Quality Control Process

OUR OFFER

DesignMake use of our expertise for the complete
development of your diagnostic assays

Use our prototypes and proof-of-concept (evaluation to verify
biomaterials and reagent formulation) or a comprehensive
range of pre-developed chemiluminescent reagents
Benefit from our offer in bulk, ready-made solutions
for turbidimetric (latex or antiserum-based) andchemiluminescent reagents

Feasibility Studies

1

Development

Clinical Studies

Manufacturing

Fill & Pack

Worldwide Registration

De novo: Design, Development, Production, Fill & Pack and Registration2

Proof of Concept: Development, Production, Fill & Pack and Registration

3

Bulk: Production and Fill & Pack

Werfen,your OEM
partnerof choiceOEM

Werfen, your OEM partner of choiceWerfen can assure IVD companies the development and supply of assays thatcover their demand needs continuously and reliably, securing their operations,through our state-of-the-art development and manufacturing capabilities.

Center of Excellence for diagnostic Assays and Biomaterials
Werfen strive to meet the highest standards of innovation and quality in the
research, development and manufacturing of assay and biomaterial solutions
for the IVD industry, with the ultimate goal of promoting greater laboratory
efficiency and better clinical outcomes for patients.

Our development achievements

Operational Excellence - continuous improvement ofprocesses, products and services
Comprehensive process management approach in order to offer
competitive solutions in terms of time to market, critical chain project
management and efficiency.
Production under GMP procedures and lean manufacturing
ISO 8 classified areas for production and filling
Extensive manufacturing scale-up capabilities
Our Manufacturing capabilities>600 References inmanufacturing>150 Million diagnostic tests
manufactured every year

> 85

chemiluminescenceassays> 50		latex
assays>160 Liters of chemiluminescentmicroparticles per batch>300 Liters of latex reagents
per batch>500 Liters of buffer per batch> 200biomaterials

Experience with> 110

analyzers

Customized Assay

5S methodology implemented in all production areas

Our Filling & Packaging capabilities

Living Immunoassay
Excellence

10 automated liquid filling lines
3 lyophilizers and>50,000 lyophilized vials per batch
Labelling automated visioninspection system>8 million vials filled per year
>1.4 million kits packed per year

3100-9769 R05 SEPTEMBER-2021

Consistently rated as a top-quality partner for OEM solutions

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

Development & Manufacturing
Living Immunoassay
ExcellenceOEM

Werfen, your OEM partner of choiceWerfen can assure IVD companies the development and supply of assays thatcover their demand needs continuously and reliably, securing their operations,through our state-of-the-art development and manufacturing capabilities.

Center of Excellence for diagnostic Assays and Biomaterials
Werfen strive to meet the highest standards of innovation and quality in theresearch, development and manufacturing of assay and biomaterial solutions
for the IVD industry, with the ultimate goal of promoting greater laboratory
efficiency and better clinical outcomes for patients.

Our development achievements

Operational Excellence - continuous improvement ofprocesses, products and services
Comprehensive process management approach in order to offer
competitive solutions in terms of time to market, critical chain project
management and efficiency.
Production under GMP procedures and lean manufacturing
ISO 8 classified areas for production and filling
Extensive manufacturing scale-up capabilities
Our Manufacturing capabilities>600 References inmanufacturing>150 Million diagnostic tests
manufactured every year

> 85

chemiluminescenceassays> 50		latex
assays>160 Liters of chemiluminescent
microparticles per batch>300 Liters of latex reagents
per batch>500 Liters of buffer per batch> 200

biomaterials

Experience with> 110

analyzers

Customized Assay

5S methodology implemented in all production areas

Our Filling & Packaging capabilities

Living Immunoassay
Excellence

10 automated liquid filling lines
3 lyophilizers and>50,000 lyophilized vials per batch
Labelling automated visioninspection system>8 million vials filled per year
>1.4 million kits packed per year

3100-9769 R05 SEPTEMBER-2021

Consistently rated as a top-quality partner for OEM solutions

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

Development & Manufacturing
Living Immunoassay
Excellence