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Mercodia Services

EVERYTHING YOU NEED - UNDER ONE ROOF


Our experience in immunoassay development combined with extensive production capacities can make your ideas a reality. Our flexibility allows us to tailor assays or specific runs to the needs of our clients, while maintaining the highest quality standards.

Mercodia supports all levels of research, providing analysis for basic, pre-clinical and clinical studies.

Mercodia can help move your projects along by performing sample analyses according to our ISO certified Quality Management System. Mercodia participates in the Swedish Medical Products Agency inspection program for GLP compliance. If requested, your analysis may be performed in compliance with OECD principles of Good Laboratory Practice (GLP). 

  Good Laboratory Practice (GLP) Certificate.

 

Mercodia Bioanalytical Service

Know what you measure

 

The Mercodia Bioanalytical Service provides you with the experience, quality and reliability that is so important when partnering with a group for biomarker analysis.

We provide: 

  • Method development, optimization and validation of PK/PD assays
  • Tech transfer and validation of assays
  • Study design
  • Validation, qualification and adaptation of commercially available kits or in-house assays
  • High-throughput sample analysis (PK, PD and biomarkers) in a GLP-certified laboratory
  • Flexible data management system with custom-made result reports

We support all levels of research, providing analysis for basic, pre-clinical and clinical studies. 

Our flexibility allows us to tailor assays, or specific runs, to the needs of our clients, while maintaining the highest quality standards.

We can help move your projects along by performing sample analysis according to our ISO 13485 certified Quality Management System. The Mercodia Quality Management System is in compliance with FDA QSR and CE/IVD directive 98/79/EC, OECD principles on GLP, the most recent international guidelines and current industry standard white papers. We participate in the Swedish Medical Products Agency inspection program for GLP compliance.

Click on the links below to read more about our bioanalytical service.

For more information, please contact
Daniel Öberg, PhD
Service Sales Manager
Phone: +46 70 090 67 24
Email: services-bioanalytical@mercodia.com

 

QUALITY BIOANALYSIS

We know that accurate and reliable results are critical when investigating a new scientific concept or working to move an idea from bench-to-bedside.

We develop, manufacture and distribute quality immunoassays using highly specific monoclonal antibodies and assay development optimization procedures to ensure excellent repeatability and reproducibility.

Our quality system was designed and is maintained in accordance with cGMP regulations. The same rigorous quality standards that govern our assay development and commercialization work are followed in the Mercodia Bioanalytical Service.

Lab Quality Assurance

  • ISO certified
  • QSR governed SOPs
  • CE & IVD marked assays
  • Documentation & traceability
  • State-of-the-art instrumentation
  • GCP compliance for sample analysis
  • Routine instrument calibration and maintenance

We have extensive analytical experience, including regulated bioanalysis, for instance from evaluating dosed drugs in samples from pre-clinical and clinical studies that are part of drug development programs from around the world. We have performed sample analysis for a wide variety of research institutes, from small academic groups to large pharmaceutical companies.

We work closely with our clients to make sure their needs are understood and met. We provide thorough documentation, transparency when it comes to all costs and status reports that will keep them informed of the progress of each phase in the study plan. 

We offer our clinets the possibility of having samples run by our own trained personnel in any of our ELISA products, your own in-house assays or immunoassays from other manufacturers. If you wish to run assays that are not part of the our portfolio, these assays will be validated and optimized to reach the best possible measurement quality.

Sample Analyses include…

  • Quality controls
  • Duplicate analysis of samples
  • Acceptance criteria evaluations
  • Reporting

We guarantee high quality sample results with minimal effort from the client.

 

GETTING STARTED

 

Sample Analysis

Samples (serum, plasma or cell culture media ) are shipped to the main facility in Uppsala, Sweden, where skilled laboratory technicians perform the analysis according to our ISO certified Quality Management System and, when requested, in compliance with OECD principles of Good Laboratory Practice (GLP). Our equipment is top-of-the-line and maintained regularly as dictated by SOPs. Samples are run in duplicate and each run is approved according to Mercodia in-house acceptance criteria, or to customer requirements.

Report

The results are delivered according to the clinetn’s specification in the form of a custom-made result report, that can be delivered straight into any system. The standard report provides approved certificate of analysis, OD, concentration and the within-run coefficient of variation for each sample. A description of the test procedure and any comments from the laboratory technician will be enclosed in the report. All reports are approved and provided as a signed PDF-file as well as an MS Excel file to facilitate data handling by the customer. An identification number is given each report for traceability, e.g. MLS10-001.

 

ASSAY MENU

Our immunoassays are based on monoclonal antibodies, ensuring long-term production and minimal lot-to-lot variation. We use well-defined in-house reference material, traceable to international standards when available. We employ our extensive assay development and optimization expertise to design assays that are highly specific and robust.

Diabetes

Proinsulin                  
- Human
- Rodent

Insulin
- Human
- Rodent
- Large Animal

C-peptide
- Human
- Rodent
- Large Animal

Iso-Insulin
- Insulin Analogue Detection

Glucagon
- Human
- Rodent
- NHP

Glicentin
- Human
- Rodent

Cardiovascular Disease

Oxidized LDL
MPO
Lp(a)

Obesity
Leptin

Linking Basic Research to Clinical Trials

We have extensive experience working with samples from animals, large and small. In addition, Mercodia has a proprietary blocking reagent that makes results from xenotransplant samples more accurate and reliable.

Mercodia assays have been used with non-human primate (NHP) samples for many years. To read more click here

Real Life Solution

A client conducting a large-scale clinical trial needed to measure a biomarker that was particularly hard to detect in the study participants but essential for determining efficacy of the therapeutic agent. We worked closely with this research group and were successful in designing an accurate and robust way to detect this protein of interest in their distinctive study population.

 

DATA REPORT

Results are always provided to the client by the deadline agreed upon by both parties (i.e., client and Mercodia). Each run is approved on fulfilment of established acceptance criteria. Our standard report includes the appropriate certificate of analysis for the assay(s) used, as well as OD, concentration and within-run coefficient of variation for each sample.

Flexibility

Mercodia has extensive expertise and decades of experience in assay development and performance.  This, combined with our close work with customers, allows us to be flexible and innovative in our solution provider role. Our data system can provide you with custom-made reports that are delivered straight ino your system. Mercodia provides unlimited data storage, access to your data at any time and redundant backup. 

Real Life Solution

A client needed data quickly so to help expedite the work, Mercodia was able to format the results differently to better suit the software needs of the large pharmaceutical company.

 

SAMPLE HANDLING AND LOGISTICS

Mercodia works with research groups all over the globe. Sample stability can have profound effects on biomarker analysis results. We understand the importance of maintaining research sample integrity, whether the samples are part of a small preclinical study or large, multi-center clinical trial.

Contact us for advice about sample handling; choice of sample tubes, additives or sample storage logistics and shipping.


Mercodia Development Service

Expertise. Delivery. Performance.

 

Mercodia Development Service offers customized development of immunoassays for Research Use Only or In Vitro Diagnostics (IVD). Each development project is unique, and needs careful consideration prior to project start.

Technologies and services include

  • ELISA/EIA development
  • Sandwich assay
  • Direct assay
  • Competitive assay
  • Colorimetric, fluorescent or chemiluminescent detection
  • Antibody kinetic characterization (ka, kd, KD) using BiacoreTM technology.
  • Epitope mapping and/or specificity characterization using BiacoreTM technology.
  • Antibody enzyme conjugation or labeling
  • Microtiterplate coating
  • Antibody characterization, screening and selection during monoclonal development

Mercodia utilizes a highly effective and mature product development process where Measurement Quality is considered and secured in every step of the way. Every project is assigned an experienced Project Manager and Development Scientists. A defined Timeline and Project Plan will be communicated prior to project start, as well as continuously throughout the project. All projects are handled strictly confidential.

Development is performed in our state-of-the-art facilities in Uppsala, Sweden.

 

Mercodia Development Service Features

 

For more information, please contact
Daniel Öberg, PhD
Service Sales Manager
Phone: +46 70 090 67 24
Email: services-bioanalytical@mercodia.com

 

Project initiation

Each project is unique with respect to goals, Intended Use and User Needs. A constructive dialogue with the Mercodia R&D team is initiated to define Design Input(product specifications) and get a clear picture of project challenges and solutions.

A dedicated Project Manager will present a defined Timeline and Project Plan prior to project start, as well as follow a communication plan during the whole project.

All projects are handled according to strict Confidentiality Agreements.

Each Project is quoted and organized individually.

 

antibody Development and Production

Mercodia work with trusted partners to develop monoclonal or polyclonal antibodies.

Our partners also provide antigen and/or immunogen preparations such as peptide synthesis, recombinant protein expression, carrier protein conjugation services, etc.

Every step in an antibody development project is monitored and specified by Mercodia to ensure that Intended Use & User Needs are fulfilled.

Mercodia has developed sensitive and accurate evaluation methods and provide screening service for the different steps in monoclonal development, i.e. animal bleeds, parental hybridoma supernatants, subclone supernatants, and purified monoclonals. We have extensive experience in the interpretation of data and the selection of clones that meet the desired performance and quality standard.

Mercodia provides an option to utilize the BiacoreTM technology to conduct specificity and affinity determinations for individual clones.

All steps are communicated and discussed between our client, Mercodia, and our collaboration partner.

If a client has a preferred collaboration partner for monoclonal/polyclonal development, Mercodia can perform additional screenings and/or support in project set-up and antibody selection during the project.

 

Feasibility study

The initial development phase is a feasibility study, where one or several immunoassay prototypes are developed. Primary reagents (antibodies and antigens) are carefully evaluated and selected and key assay performance parameters are checked.

During this phase Standard Operation Procedures (SOPs) are followed for e.g. microplate coating, enzyme conjugation and buffer compositions. These proprietary methods and buffers are well defined and have been proven in Mercodia’s own development projects.

 

Phase 1

Project Phase 1 is dedicated to optimizing the prototype developed in the Feasibility Study. During this phase, all product components, test procedure, and features are optimized to meet assay requirements (design input) for the specific analyte, e.g. sensitivity, measuring range, specificity, etc.

A preliminary assay design validation is conducted.

During this phase, the client has the option to evaluate assay performance at their site and/or do a preliminary assay validation prior to entering large-scale manufacturing.

 

Phase 2

Phase 2 is mainly Design Transfer from R&D to Production. This involves writing Device Master Record (DMR) and setting Specifications and Acceptance criteria for the manufactured product.

A first batch is produced according to the DMR and verified/validated according to Technical Specifications, User needs and Intended Use, and stability studies are initiated.

When the produced assays are approved according to the set specifications, the assay is supplied to the customer site. Alternatively, Mercodia Bioanalytical Service can be contracted for convenient sample results.

Kits are produced according to agreed upon delivery schedules or upon request.

Three batches are produced and validated, including stability studies, for those kits requiring CE-labeling and/or FDA registration.

Mercodia Production Service

Experience. Quality. Reliability. 

 

Mercodia has been a supplier of reliable immunoassays since 1991. During the past two decades we have optimized our production processes using all the experience and knowledge gained over the years.

We offer custom production of immunoassay kits or individual components in areas such as:

- Bulk production
- Coating of 96-well microplates
- Dispensing
- Lyophilization (freeze-drying)
- Labeling
- Packaging

Our procedures and processes are highly regulated and are in accordance with the ISO 13485 standard and comply with the requirements stated in FDA QSR.

All production is taking place at our state-of-the-art facilities in Uppsala, Sweden, where we have extensive production capacities. 

For more information, please contact
Daniel Öberg, PhD
Service Sales Manager
Phone: +46 70 090 67 24
Email: services-bioanalytical@mercodia.com