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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).

 

Mercodia Bioanalytical Service

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

Mercodia provides: 

  • Method development, optimization and validation of assays for PK/PD studies, closely following the most recent international guidelines and industry standard white papers.
  • 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, delivered straight into your system. 

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 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 and  current industry standard white papers. Mercodia participates in the Swedish Medical Products Agency inspection program for GLP compliance. 

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

For more information, please contact
Annika Carlsson, PhD
Research Manager
Phone: +46 18 170428
Email: services-bioanalytical@mecodia.com

 

Quality Analysis

Mercodia develops, manufacturers and distributes quality immunoassays using highly specific monoclonal antibodies and assay development optimization procedures to ensure excellent repeatability and reproducibility.

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.
Mercodia’s quality system was designed and is maintained in accordance with cGMP regulations.  The same rigorous quality standards that govern Mercodia’s assay development and commercialization work are followed in the Mercodia Laboratory Service.
 
Lab Quality Assurance Sample Analyses include…
  • Quality controls
  • Acceptance criteria evaluations
  • Duplicate analysis of samples
     

 

Getting Started

Mercodia has 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 you informed of the progress of each phase in the study plan. 

We offer you the possibility of having your samples run by our own 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 Mercodia portfolio, these assays will be validated and optimized to reach the best possible measurement quality. Mercodia guarantees high quality sample results with minimal effort from the client.

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 SOP. 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  your specification in the form of a custom-made result report, that can be delivered straight into your 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, always 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
- Porcine
- NHP

Glicentin
- Human
- Rodent

Cardiovascular Disease

Oxidized LDL
MPO
Lp(a)

Obesity
Adiponectin
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.

"We also do custom assay development work."

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.

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.

 

Non-Human Primate Models

Mercodia assays have been used with NHP samples for many years. Below is a list of some of these groups, as well as the Mercodia assays used in the highlighted publications.  Click on the hyperlinks to view the abstracts.

 

 

Tissue-specific regulation and expression of heat shock proteins in type 2 diabetic monkeys

  • Wake Forest University
  • Proinsulin, Insulin, C-Peptide & OxLDL
 

Proof of mechanism and PK and PD relationship study in cynomolgus monkeys

  • Pfizer, Covance & University of Birmingham
  • Insulin

In vivo Imaging of Autologous Islet Grafts in the Liver and Under the Kidney Capsule in Non-Human Primates

  • Harvard, Mass. Gen. Hospital & Joslin Diabetes Center
  • Insulin

Effect of a PPARa agonist on plasma lipids, lipoproteins, and glycemic control in diabetic monkeys

  • Wake Forest University & Pfizer
  • Adiponectin, Insulin & C-Peptide
 

Collaborative Studies
Mercodia worked with a prominent scientist in the metabolic field to validate our assays with NHP samples.  This was important because the assays were originally optimized for human samples and there can be various aspects of a different sample type (e.g., sequence homology, matrix effects, etc.) that can negatively affect assay results.  
The original data from this collaboration was presented at the 2009 IPITA meeting.
Validation results with NHP samples included:

  •      Excellent precision
  •      No matrix interference
  •      Highly accurate
  •      Choice assays for IVGTT studies in NHP models

 

 
 
 
 

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 fulfillment 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 know 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

 

 

Mercodia ImmunoAssay 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.

Mercodia utilize 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.

Technologies and Services

  • 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
  • Microtiter plate coating
  • Antibody Characterization, screening and selection during Monoclonal Development
 

Mercodia Immunoassay Development Service Features

  • Workflow
  • Flexible and customized project outline ranging from antibody development to assay manufacturing in large or small scale.
  • Access to highly experienced and skilled development team and project managers, proven by the current Mercodia immunoassay product range.
  • State-of-the-art equipment and facilities.
  • Development and Manufacturing in compliance with ISO13485.
  • Assays for “Research Use Only” or “In Vitro Diagnostic” use.
 

For more information please contact: 

Robert Gunnarsson
Managing Director Research & Development 
Tel: +46 18 17 04 24
Email: robert.gunnarsson@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.

Monoclonal / Polyclonal 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 called 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. microtiter plate 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 Laboratory 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

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 can offer our clients custom production of immunoassay components according to customer requirements in areas such as:

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

All procedures are in accordance with the ISO 13485 standard and complies to the requirements stated in FDA QSR.

For more information, please contact

Helene Hagberg
Managing Director Production
Tel: +46 18 170 420
Email: helene.hagberg@mercodia.com