YOUR LATERAL FLOW PARTNER FOR RESEARCH, DEVELOPMENT AND MANUFACTURE

Mologic offers a complete range of services to researchers, developers and manufacturers of rapid point-of-care assays and devices.

Our team of more than 40 scientists has extensive experience in dealing with simplex or multiplex tests, device housing and product design, both for unique test systems and for Mologic’s innovative enzyme activity detection (ELTABA) platform.

We can help with everything from identifying the right proteins and antibodies to designing the most effective device and scaling up low to mid-volume manufacture.

Assay Development

  • Development and manufacture of LFIA (lateral flow immunoassay) products

  • Development and manufacture of ELISA (enzyme linked immunosorbent assay) products

  • Nanoparticle technology implementation and optimization

  • Reagent (antibody/antigen) orientation, deposition and conjugation

Our success in immunoassay development is achieved by harmonization of many scientific disciplines including molecular biology, biochemistry, immunology, engineering and particle science.  Mologic’s experience, including work on the first commercialized rapid pregnancy test, has enabled us to develop diverse immunoassay products. Our approach begins with an understanding of market needs and design specifications to select a detection scheme and proper test through-put.  We’ve developed traditional ELISA (enzyme linked immunosorbent assay) products as well as standard lateral flow immunoassays for use in point-of-care or over the counter (OTC) settings. We’ve also developed unique formats and platforms for lateral flow products that include analysis with algorithms, readers and connected devices. Mologic assay development projects emphasize the selection and optimization of nanoparticle size, composition and conjugation parameters as well as critical reagent (antibody / antigen) orientation and deposition within the immunoassay. Our team of scientists are highly trained in testing assay performance with clinical samples and analytical standards. In addition, Mologic assay development offerings include:

  • Development of electrochemistry detection products, that may include unconventional techniques
  • Stability testing of finished goods and in-process materials
  • Specialized regulatory and quality system advice for in-vitro diagnostics including ISO 13485:2016 and MDSAP approval

Reagent Development

  • Antibody development (polyclonal, monoclonal, recombinant Fab)

  • Peptide and antigen synthesis

  • Recombinant protein production (E. coli and yeast)

  • Microbiology (class I and ll), prokaryote and lower eukaryote

Mologic has produced hundreds of rare biomolecules for clients and for our own in-house development. Our expertise is in the production of highly specific and well characterized reagents including those used in immunoassays where performance is directly related to reagent sensitivity, specificity and purity. We have deep experience in developing or sourcing high affinity antibodies and controlling methods for production of recombinant Fab binding molecules that are directed toward your analyte of interest. These antibodies are selected based on their ability to function in the final desired immunoassay format. In addition, we’ve developed methods for increasing the immunogenicity of your antigen with the inclusion of virus like particles (VLP) in the immunization strategy. We can also provide epitope mapping of the antigen to confirm the specificity of the response. Mologic offers peptide and antigen synthesis, nanoparticle / enzyme conjugation and enzyme substrate optimization.  Mologic also provides additional reagent development services related to:

  • Epitope design (rational)
  • Recombinant antibody production
  • Traditional Polyclonal and monoclonal antibody development
  • Recombinant protein production (E. coli and yeast)
  • Microbiology: prokaryote and lower eukaryote (class I and II organisms)

Reagent Enrichment / Process Development

  • Affinity purification

  • Assay component procedure development

  • Recombinant binding molecules

Affinity purification is an ideal way to increase reagent specificity. Mologic can provide detailed purification strategies or deliver highly purified material based on your target antigen. Mologic offers additional process development services relating to enrichment of recombinant proteins and monoclonal antibodies. Our experience in immunoassay design has allowed us to optimize and develop procedures for biomolecule conjugation, buffered surfactants and scale-up for manufacturing.

Reagent Analysis

  • Spectrometry tools (UV/VIS, fluorimetry, dynamic light scattering, and mass spectrometry)
  • Flow cytometry and imaging microscopy

  • HPLC and FPLC chromatography

  • Binding characterization and measurement including label free kinetic analysis

Impure reagents can lead to downstream design flaws and finished product instability, so it is crucial we ensure reagents are free of contaminants. Mologic has invested heavily in both staff and equipment capability to fully assess reagent purity. To do this, we utilize chromatography tools (ex. FPLC, HPLC), electrophoresis tools (ex. SDS-PAGE/ Western blot) and spectrometry tools (ex. UV/VIS, fluorimetry, dynamic light scattering, and mass spectrometry).

The characterization of biomolecule activity is paramount to its utility and allows for appropriate downstream inclusion. Our capability uses information gathered from peptide epitope mapping, bioactivity testing, flow cytometry / imaging microscopy and label free kinetic analysis (which is superior to SPR results) to optimize the reagent’s ability to exceptionally function in the finished product.

Our development packages (immunoassay, antibody, recombinant protein) include a range of analytical testing methods to ensure quality and activity of critical reagents specifically relating to identity, purity, and stability. We are also able to offer reagent analysis as a standalone service to provide characterization for already developed materials.

Device Format Development

  • Patented ELTABA (enzyme activity detection) technology implementation

  • Lateral flow housing and material format

  • Integration of sample collection and processing steps

Immunoassays come in many shapes, sizes, and forms. Mologic has been involved in them all, from microwell EIA testing, to dipstick lateral flow tests, to fully integrated over the counter disposable systems. Our experience can help determine proper detection strategy (enzymatic, electrochemical, visual nanoparticle) as well as test through-put. We also have the ability for rapid prototyping (3D printing) to create custom housing that can integrate sample collection and the processing steps.

Mologic also offers services related to laser etching and freeze dry lyophilization. In addition, our patented enzyme activity detection technology (ELTABA) is available for use.

Evaluation Services

  • Sample matrix effects and clinical sample utility

  • Preliminary shelf-life stability

  • Usability, up-stream marketing, voice of the customer

Mologic core competency is in delivering immunoassays that meet a market need. This involves verifying clinical utility with confirmed samples, characterization and elimination of sample matrix effects, and product shelf-life stability. These important activities are included with any of our contract development offerings and can be utilized separately, for your specific needs. In addition, Mologic offers consulting services relating to human factor usability, up-stream marketing and voice of the customer.

Validation Services

  • Small scale clinical trials

  • Training and user simulation sessions

  • Regulatory documentation

Verification and validation of finished products through Mologic’s QMS system is essential to ensure lasting performance and manufacturability. We are ISO 13485:2016 and MDSAP approved and can provide IQ/OQ/PQs, design history files, batch records and other required regulatory documentation. We have strong links to the clinical community and have undertaken numerous trials, so we can facilitate small scale clinical trials as well as training sets and user simulation sessions.

Manufacturing

  • Optimized for low to mid-volume applications with a roadmap to high volumes

  • Research pilots and validation batches

  • Branding, packaging and instructions for use

  • ISO 13485:2016 and MDSAP

Mologic offers on-site manufacturing for immunoassays and recombinant bio-molecules in our ISO 13485:2016 and MDSAP approved manufacturing facility. Our equipment has been optimized for low to mid-volume applications and we have a roadmap to high volume production. Our dedicated manufacturing staff can produce research pilot runs, validation batches and finished product transfers. We can source and implement your branding and packaging requirements including instructions for use, boxes and additional test components.

More Information on

Research & Development

Antibody Development

Recombinant Protein Development

Contract Manufacturing

Quality

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