Immunoassay Technology Center

Developing and manufacturing immunoassays and biomaterials

Our technology center located in Barcelona, Spain has vast experience in researching, developing, and manufacturing customized assays and biomaterials. Our primary focus is to develop and manufacture hemostasis immunoassay products for various Werfen platforms and biomaterials used to produce products for autoimmune diseases.

We also offer comprehensive solutions to the diagnostics market with innovative capabilities that enhance competitiveness and reduce time-to-market.

Customizing innovative solutions that reduce time to market

We provide the most innovative solutions, enhancing unique product features, and reducing time to market. For us, continuous improvement not only applies to industrial efficiency, but also to innovation, quality, and service. This allows us to provide diagnostic solutions from the early stages of product development to product commercialization, including high-value services, such as clinical studies, worldwide registration, and on-market product support.

Bringing innovation across the healthcare ecosystem

We aim to improve patients’ quality of life, using innovation and state-of-the-art technologies to commercialize the highest-quality diagnostics products.

In parallel, we streamline the development process and assess novel biomarkers, collaborating with various stakeholders across the healthcare ecosystem.

Our partnership with global IVD companies is based on a strong commitment to quality, innovation, and operational excellence.

Immunoassay

As in previous years, we continued to make significant progress across multiple business areas, advancing our strategic initiative to establish ourselves as the reference partner in the in vitro diagnostics sector for immunoassay and biomaterials development and supply. 

Thanks to our increased credibility and reputation for reliability in the market as a biomaterials developer and manufacturer, in 2024, we started developing two chemiluminescent assays for a top five IVD company. We also expanded the commercialization of our first pre-market approval product for another leading IVD company, manufacturing the first lot to stock for the Chinese market and preparing the IVDR regulation product launch. 

We developed 13 new biomaterials and completed the manufacturing transfer and validation of five products. During the year, we also worked to ensure our core business supply chain, designing a plan to develop several key raw materials for our Transfusion business unit. 

We also strengthened our commitment to quality and operational excellence through impactful initiatives. We conducted over 700 training sessions covering specific quality topics and Quality & Regulatory procedures and implemented 300 continuous improvement initiatives. During the Quality Week, Chartered Quality Institute and International Register of Certificated Auditors initiative, we expanded our efforts by organizing quality-focused activities and passed multiple external audits, achieving recertification for ISO 13485, Medical Device Single Audit Program, and IVD regulation. 

José Luis Zarroca
Chief Operating Officer
Immunoassay Technology Center
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2024 business highlights

Addition of 13 new biomaterials to our product portfolio

Started development of two new immunoassays with a top five IVD company

Expanded commercialization of our first PMA product by manufacturing the first lot to stock for the Chinese market and preparing the IVDR product launch

Implementation of 300 Continuous Improvement initiatives

Our product: Powering Patient Care

HemosIL DDimer

HemosIL®

HemosIL D-Dimer assays are clinically validated with cut-off values for the exclusion of venous thromboembolism (VTE), including both pulmonary embolism (PE) and deep vein thrombosis (DVT), in conjunction with a pretest probability assessment. This approach can reduce the need for costly and invasive imaging tests, typical in the diagnosis of VTE.

Learn more

Clinical Chemistry

Clinical Chemistry develops and supports unique and innovative solutions for clinical chemistry and toxicology from our manufacturing center in Italy. Our instruments and reagents help clinicians worldwide to deal with drug abuse, and to diagnose conditions such as diabetes.

Toxicology market leader in Italy

As the toxicology market leader in Italy, the core of our strategic plan is the concept of a true Toxicology Ecosystem: offering complete, innovative, cutting-edge solutions to the toxicology community of tomorrow. A superb example of this approach is Oxycodone: a key marker to counter the ongoing opioid crisis.

Other Specialized Diagnostic products

Continued growth

Identifying human genetics

In addition to our portfolio of proprietary Specialized Diagnostic products, some of our affiliates, mainly those in Spain, Portugal, and Mexico, distribute analyzers, reagents, and controls from internationally recognized partners.

We are proud of these long-standing partnerships, which allow us to deliver these products essential to molecular biology, microbiology, and applied science. This segment of our business continues to grow thanks to the specialized, technical, and application expertise within our affiliates.

Identifying human genetics
Note: All sales growth numbers are at Constant Exchange Rate and Constant Perimeter.