Services We are focused on offering you high-class bioanalytical services for large molecule and ligand binding assays (LBAs). With over 100 years of combined experience in immunoassay development, validation, production and sample analysis, we can guide and support you from exploratory research to clinical studies. Our flexibility allows us to tailor assays or specific runs to your needs, while maintaining the highest quality standards. LBA (Ligand-Binding Assay) Development Mercodia’s know-how of developing immunoassays provides a unique expertise within the LBA field. By utilizing proprietary buffers and matrix interference reagents, complete and accurate in vivo and in vitro protein quantification can be achieved. We can deliver integrated bioanalytical solutions for your toughest assay needs. In fact, we excel in some of the most demanding areas of bioanalysis today, where extensive, expert-level skills are required. The development can start from scratch by: - designing antigen binders - building an assay prototype - validating the assay for the intended use - producing the assay in small or large scale But it can also be adapting or optimizing an already developed assay for a new intended use by e.g. adapting the assay for another matrix, lowering sample volume or shortening assay time. The transfer of an assay (for example a non-optimized assay) to Mercodia is referred to as a tech-transfer which is an integrated part of our service offer. Contact us for more info Sample Analysis Our flexibility allows us to tailor assays or specific runs to customer needs. We support all levels of research, providing analysis for discovery/development, pre-clinical and clinical studies. Samples are shipped to the main facility in Uppsala, Sweden, where skilled laboratory technicians perform the analysis according to Good Laboratory Practice (GLP) and Standard Operating Procedures (SOPs). Each run is approved on fulfillment of established acceptance criteria and the results are reported to the customer within an agreed time frame. We provide standardized reports following the recommendations in FDA, EMA and ICH guidelines. Contact us for more info Assay Menu Mercodia Services includes measuring analytes with assays in our product portfolio, custom developed assays or with other commercially available assays. Download Assay Menu Immunogenicity Mercodia has a proven track record for developing and validating ADA assays used during immunogenicity testing. Unwanted immunogenicity is an immune response by an organism against a therapeutic antigen (e.g. a drug). This reaction leads to production of anti-drug antibodies (ADAs), which may inactivate the therapeutic effects of the treatment and, in rare cases, inducing adverse effects. Contact us for more info Biosimilar Drug Projects Mercodia provides a commercially available insulin analog-specific assay, Lispro NL-ELISA, tailored for the use during several stages of the drug development process. In addition, Mercodia has proven to be a central player when it comes to insulin measurements and was the only ELISA manufacturer to satisfy the total error requirements in the American Diabetes Association (ADA) Insulin Standardization Study (Miller et al, 2009). With the work invested in formulating criteria for drug development kit and the commitment our team has shown in measurement quality, Mercodia’s expertise is useful for sponsors wishing to succeed in their biosimilar drug projects. We can guide and support your bioanalytical strategy to secure a successful project outcome. Contact us for more info Pre-validation and validation Mercodia has extensive experience in following guidelines from FDA, EMA and ICH. Since PK/PD and immunogenicity studies are an important part of the drug development process there are high demands on the tools used for these purposes. Before starting a validation, a pre-validation could be needed to show if an assay is ready for validation. Mercodia has extensive knowledge and can guide the client in planning and executing a pre-validation. It will be evaluated if further optimizations or tweakings are necessary to achieve acceptable measurement quality. Before included in a preclinical or clinical study, it must be proven that the assay can be used for the intended use. The goal of a validation is to show that: 1. the assay measures the intended analyte. 2. the variability of the assay is acceptable. 3. the assay gives reliable data within the intended concentration range 4. reliability of data is obtained when established recommendations for sample collection, handling, and storage are followed. A full validation for PK or biomarker analysis includes studies on selectivity (including parallelism), specificity, sensitivity, accuracy, precision, stability, dilutional linearity, hook effect, calibration curve and range. Depending on the intended use of the assay (e.g. pivotal study that require a regulatory decision making for approval or internal decision making), the level of validation (and cost) can be adapted (scaled). This is performed using a risk-based approach and in collaboration with the customer. Mercodia takes an active part in the preparation of industry guidelines and white papers concerning bioanalytical method validation. Several of Mercodia kit products are validated following the guidelines from EMA and FDA and the validation report can be provided upon request. Mercodia also takes advantage of internal knowledge in validating our own commercial products, e.g. in the validation of Lispro NL-ELISA for an extended context of use in toxicology studies. Download the poster below to learn more about that project. Download poster Reagent Characterization Characterizing the reagents is of utmost importance for good assay performance. Mercodia Reagent Characterization Service offers characterization of reagents with ELISA and/or surface plasmon resonance (SPR) using Biacore™ technology*. The service includes studies to determine: - Concentration - Functional concentration using Biacore™ calibration-free methods - Test/assessment of functionality - Specificity - Selectivity - Lot-to-lot comparison - Binding kinetics and affinity determination (Biacore™) - Epitope mapping Download poster Reagent Control Mercodia has comprehensive knowledge around critical reagent management processes to support assay needs throughout the lifecycle of drug development – from discovery and development to post-marketing surveillance. Critical reagents are defined as reagents that significantly alter or curtail the performance of the assay. It is clear that these reagents need to be monitored and controlled to secure analytical results in the long-term but also in the short-term. However, analytical issues for pharmacokinetics (PK) assays may be different from clinical assays depending on how the assay is used during different phases of drug developmental programs. There may exist a need to manage multiple reagent lot changes and their long-term storage stability but there is clearly no one size fits all approach. Efforts to manage reagent life cycle often fit into either the use of: 1. a large volume lot where stability and storage logistics would be a major concern OR 2. a small volume lot where the management of lot changes would be the main concern Control of critical reagents is fundamental to the quality and long-term performance of LBAs. We can guide the client on crucial parameters regarding scaled up production of calibrators (standards), coated plates, antibody conjugation and more. Contact us for more info Custom Production At our state-of-the-art facilities in Uppsala Sweden we have extensive production capacities to be used in service projects. During decades we have produced solutions for the life science industry and now we decided to offer the service to more clients. We can produce buffers, assay components or full LBA kits etc. With production, QC and QA working closely together we can make sure that the process flows smoothly and effectively from start to finish. The custom production service can easily be combined with other parts within our service offer. Contact us for more info ...and more! Every project is unique and there is no solution to fit all. Mercodia aims to be the best solution provider and a great partner for small projects as well as larger ones. We wish to be flexible and meet the needs of our clients in the best possible way. Let us know what you need and we will find the solution! Contact us To be a great partner it is important for us to understand your project. Contact us for a project proposal Wide network No man is an island and no project will succeed without a working team. All projects run at Mercodia have access to expertise within quality assurance, quality control, product development and project management. In addition, Mercodia has a business network with selected partners that can add specific services to a project. Together we can improve human health. Managers Hanna Ritzén, Managing Director R&D Hanna Ritzén started her career at Mercodia as a Product Development Scientist in 2002, and has since held different positions in Research and Development. She has been involved in the CAPA process and life cycle management of the internally developed and produced ELISA kits for the detection of biomarkers in both human and animal samples. Today, she is Head of R&D and manages product development of commercial IVD and RUO ELISA kits, post-market surveillance, assay development and validation, and sample analysis. She is also involved in the clinical laboratory test standardization and harmonization of Insulin and C-peptide biomarker methods administered by the American Association of Clinical Chemistry. Annika Carlsson, Service Manager Dr. Annika Carlsson manages regulated bioanalysis for Pharma and CRO drug development programs, as well as non-regulatory studies for academia. With 6 years of experience of academic research in beta-cell damage pathways, combined with 13 years of experience of ligand binding assay development and validation within the industry, she brings together scientific as well technical knowledge to the Mercodia Bioanalytical Services team. She is driven by a dual interest of understanding the scientific rational behind biomarker and PK studies, combined with a thorough understanding of what is expected from a regulated perspective in terms of FDA and EMA guidelines. Daniel Öberg-Arendt, Service Business Manager As Service Business Manager, Daniel Öberg-Arendt establishes supporting partnerships with clients running drug development and biotech projects. Daniel’s expertise stems from an impressive academic career with several years as Postdoctoral Research Assistant and Group leader at Bart’s Cancer Institute, London. Daniel has a great understanding of the scientific process and can use his leadership skills in giving clients the best possible support to finish a successful project. Experts Sandra Sköld Chiriac, Senior Study Analyst & Coordinator After her Ph.D. at Lunds University, Sandra Sköld Chiriac brought her expertise and leadership skills to Mercodia. She is coordinating service projects making sure that the deliverables are completed and transferred to the client in a timely manner. Tanja Jarhede, Senior scientist Dr Tanja Jarhede received her Ph.D. in Biochemistry in 1996. She brings almost 20 years of knowledge and experience on surface plasmon resonance technology (Biacore™) and several years on ELISA. Tanja has a proven track record of expertise within assay development, reagent characterization, immunogenicity and bioanalytical method validation. Susanna Nybond, Scientist Susanna Nybond has a strong interest in research and received her Ph.D. in Pharmaceutical Sciences. With her experience in drug discovery and pharmaceuticals, together with her skills in assay and method development, she brings great value to the team. Sara Hedlund, Assay Development Specialist Sara Hedlund has a broad expertise within ligand binding assays (LBAs) and brings extensive experience from assay production to assay development and validation. Fredrik Vellby, Senior Study Analyst Fredrik Vellby has broad knowledge in bioanalysis after working in the Life Science Industry for many years. With his laboratory skills and expertise, he adds extraordinary capacity to the team. Alice Azémar, Study Analyst Alice Azémar has a bachelor’s degree from Université Paul Sabatier in Toulouse, France and a master’s degree from Uppsala University. This talented researcher is a determined and reliable resource for the Mercodia team. Welcome to get in touch with us! General queries Email:info-global@mercodia.com Phone:+46 18 57 00 70 Support Email:support@mercodia.com Phone:+46 18 57 00 70 Place orders at Global:orders-europe@mercodia.com Phone:+46 18 57 00 71 USA:orders-usa@mercodia.com We have offices in several parts of the world and subsidiaries both in Europe and in the US. Headquarters Sylveniusgatan 8A, SE-754 50 Uppsala, Sweden Email:info-global@mercodia.com Phone:+46 18 57 00 70 Mercodia France SAS 10 rue Emile Allez 75017 Paris Email:myriam.kacimi@mercodia.com Email:info-europe@mercodia.com Phone:+ 33 6 13 38 48 02 Mercodia Inc 1590 Westbrook Plaza Drive Suite 201 Winston Salem NC 27103, United States Email:info-usa@mercodia.com Phone:(336) 725-8623 Find your local distributor here. Social media Join our social media to follow the latest updates and news! Social media LinkedIn Twitter Facebook YouTube Press Email:press@mercodia.com (c) Mercodia AB 2019 We use cookies to give you the best experience on our website. Do you agree to the use of cookies? Read more Agree