Supporting Diagnostic Manufacturers with Assay Development

Method Development

During method development, the primary goal is to optimize the assay procedure to reliably detect the target analyte(s) under intended use conditions and within the appropriate sample matrix. To support this stage of development, Microbix offers customized quality controls.

Custom-Developed Controls

Microbix designs and develops custom positive, negative, and sample process controls tailored to meet your assay’s specific needs. You can select:

• Target Organisms: Whole genome, gene constructs, or amplicons for molecular applications. Native or recombinant proteins for immunoassay applications.
• Control Types: Whole-process, amplification-based, and/or sample process controls for molecular applications.
• Target Concentrations: Quantified via digital PCR for molecular applications.
• Formats: Stabilizing liquid buffers (2-8°C), Copan FLOQSwab® for point of care applications (2-30°C), and Formalin-Fixed, Paraffin-Embedded (FFPE) slides for histology-integrated workflows.
• Regulatory Support: Comprehensive assistance with technical file documentation for control materials, ensuring compliance with regulatory requirements.

White-label Controls

Microbix offers white-labelled, custom-developed controls that can be seamlessly integrated into diagnostic assay kits, supporting brand consistency and streamlined product deployment.

Analytical Validation

During Analytical Validation, the developed assay undergoes comprehensive testing to evaluate its accuracy, precision, linearity, reportable range, limit of detection (LOD), and limit of quantitation (LOQ). These assessments are critical for determining whether the assay meets regulatory requirements. Microbix’s characterized reference materials are ideally suited to support these validation studies.

Reference Materials for Early-Stage Assay Development and Analytical Validation

Microbix enables faster, more reliable assay development by offering characterized reference materials. These products are formulated with highly concentrated, titered, and traceable pathogens that have been inactivated to meet biosafety requirements. Reference materials are ideal for benchmarking assay performance throughout development and establishing analytical metrics such as Limit of Detection (LOD), sensitivity, and specificity.

Visit our Reference Materials page for more information.

Clinical Validation

Following Analytical Validation, clinical trials are conducted using patient samples to confirm the assay’s diagnostic performance. To support these trials, Microbix’s custom white-label controls or External Quality Controls (EQCs) can be used alongside patient samples to verify assay performance and ensure consistency throughout the clinical evaluation process.

Assay Manufacturing Scale-Up

Once the assay successfully passes all stages of development, it can be commercialized for routine use in diagnostics or research applications. This phase involves scaling up production, implementing robust quality control, and managing packaging, labelling and distribution of the product. Microbix’s quality controls and packaging services help ensure consistency and reliability throughout every stage of scale-up and commercialization.

Quality Control

Microbix supports diagnostic manufacturers during assay scale-up and full-scale production by providing quality controls with excellent lot-to-lot reproducibility and extended shelf-life. These products are ideal for conducting assay reagent stability studies, monitoring reagent lot consistency, and facilitating lot release testing.

Scale-Up White-label Controls

Microbix offers white-labelled, custom-developed controls that can be seamlessly integrated into diagnostic assay kits, supporting brand consistency and streamlined product deployment.

All controls are produced under ISO 13485:2016 in BSL-2+ certified facilities.

Outsource Product Packaging and Vial Filling

Our aseptic vial filling services focus on liquids across various fields, such as healthcare, biotechnology, and more. Our vial batch size ranges up to approximately 60,000 vials per batch with the following production lines:

• The development and pilot scale (capabilities of 10,000 vials per day) offers a versatile and flexible run size on a semi-automated system, is scalable, can accommodate different fill volumes, and requires minimal commitment.
• The commercial scale (capabilities of 60,000 vials per day) is fully automated, available on short—and long-term commitments, a seamless scale-up from the pilot scale system, and includes capping and labelling.

Visit our Vial filling page here.

Commercial Launch Support

ONBOARDx™ Kits and External Quality Controls for Market Introduction

Ensure rapid market adoption and confident customer onboarding with Microbix’s custom onboarding and post-market QC solutions:

ONBOARDx™ Kits

• Select your preferred number of positive and negative samples to create a custom training and verification panel for your end-user onboarding (Minimum quantities apply).
• Includes positive/negative samples and optional Control Elution Buffer (1 mL or 3 mL) for kits with PROCEEDx™FLOQ® samples.

External Quality Controls (EQCs):

• Platform-agnostic, unassayed REDx™ Controls (CE-IVD).
• PROCEEDx™ Samples (RUO) for validation/verification and operator training.

Learn more about our QAPs product line here.

These tools help diagnostic manufacturers facilitate adoption, train clinical labs, and support product reliability in post-market use.