Custom and Manufacturing Services for qPCR

Accelerate your product development by taking advantage of our custom products, services, and manufacturing options. Our R&D scientists are experts in real-time PCR technology. Partnering with us in assay development and manufacturing will allow you to focus on your technology; we will take care of the rest. 

Contact us

You have deadlines to meet and limited time to build expertise or scale resources. Our Custom qPCR Services Team can help. With extensive experience developing, verifying, and validating qPCR products and workflows, we can help you meet your R&D objectives and get to market faster. We have the capabilities needed to support your MDx development from initial feasibility all the way through to final kitting and supply

Feasibility

 Assay design
 Performance testing
 Custom products
 Workflow development

Development

 Workflow optimization
 Bridging studies
 Guard banding

Verification

 Manufacture transfer
 Verification testing
 Analytic validation testing

Validation

Manufacturing
Stability studies

Custom formulation

Our team can assist you by creating custom master mixes and individual custom reagents. Our extensive experience and broad knowledge creating high-quality molecular biology reagents enables our team to provide cost-effective and robust solutions for your specific projects.

Custom manufacturing

Add efficiency and convenience to your lab with our custom packaging services. We provide your choice of fill sizes, inner and outer packaging, custom kitting, custom labeling, and more.

  • Choice of tube and bottle sizes-extra-small to extra large volumes (bulk)
  • Variety of plate formats
  • Custom kit configurations
  • Private labeling
  • Fill/finish 

We are committed to delivering high-quality products—and meeting the highest standards for quality. We offer a choice of manufacturing environments to meet your specific needs.

  • ISO 9001
  • ISO 13485
  • CFR 21 Part 820 Compliant QMS (cGMP)

We also provide custom reagents under a choice of labels for several specific uses, including:

  • RUO (research use only)
  • ASR (analyte-specific reagents)
  • GPR (general purpose reagents)
Lyophilization solutions

Lyophilization or freeze drying has become increasingly popular for molecular assays, due to the convenience and cost savings. Thermo Fisher Scientific offers lyophilization-compatible reagents and can lyophilize your assay for you. We will work with you to ensure your lyophilized assay retains the great performance of your original wet assay.

Benefits of lyophilization

Convenience: all reagents dried down in one reaction reduces the chance of pipetting error and saves time in the hands of the end user

Cost: eliminates the need for cold-chain shipping, significantly reducing costs; longer shelf life reduces waste due to product expiry

Stability: ship assays globally; they will arrive safely to your customers, even with potential hot temperatures or long distances

Shipping: because dried down reagents are room temperature stable, they can all be shipped together and kept at the same temperature

scheme

Why work with us?

By sourcing your reagents and your lyophilization services from the same supplier, you can drastically reduce the complexities in your supply chain. Your assay will be delivered to you, ready to go. We have heavily invested in our own lyophilization and manufacturing capabilities, so that you don’t have to.

Our products are manufactured in clean room facilities certified according to EU directives and ISPE guidelines, and in compliance with ISO 9001, ISO 13485, ISO 14001, OHSAS 18001 certification. Lyophilization is performed in environmentally-controlled rooms.

Optimizing your assay into a dry format

We work with you to optimize your assay with lyo-ready reagents and excipients in a wet format. Then, we begin manufacturing smaller amounts of lyophilized assay to ensure performance of the dry assay. Once the dry assay is optimized, we scale up manufacturing so that you can perform analytical and clinical validation on the dry assay.

Workflow
  • Confirm assay performance with lyo-ready reagents and excipients
  • Optimize assay and cycling parameters
  • Confirm lyophilized assay performance
  • Lock down assay formulation, specifications and test parameters
  • Confirm and document that the test works as intended
  • Confirm the clinical validity, utility, sensitivity and specificity of the test

You have deadlines to meet and limited time to build expertise or scale resources. Our Custom qPCR Services Team can help. With extensive experience developing, verifying, and validating qPCR products and workflows, we can help you meet your R&D objectives and get to market faster. We have the capabilities needed to support your MDx development from initial feasibility all the way through to final kitting and supply

Feasibility

 Assay design
 Performance testing
 Custom products
 Workflow development

Development

 Workflow optimization
 Bridging studies
 Guard banding

Verification

 Manufacture transfer
 Verification testing
 Analytic validation testing

Validation

Manufacturing
Stability studies

Custom formulation

Our team can assist you by creating custom master mixes and individual custom reagents. Our extensive experience and broad knowledge creating high-quality molecular biology reagents enables our team to provide cost-effective and robust solutions for your specific projects.

Custom manufacturing

Add efficiency and convenience to your lab with our custom packaging services. We provide your choice of fill sizes, inner and outer packaging, custom kitting, custom labeling, and more.

  • Choice of tube and bottle sizes-extra-small to extra large volumes (bulk)
  • Variety of plate formats
  • Custom kit configurations
  • Private labeling
  • Fill/finish 

We are committed to delivering high-quality products—and meeting the highest standards for quality. We offer a choice of manufacturing environments to meet your specific needs.

  • ISO 9001
  • ISO 13485
  • CFR 21 Part 820 Compliant QMS (cGMP)

We also provide custom reagents under a choice of labels for several specific uses, including:

  • RUO (research use only)
  • ASR (analyte-specific reagents)
  • GPR (general purpose reagents)
Lyophilization solutions

Lyophilization or freeze drying has become increasingly popular for molecular assays, due to the convenience and cost savings. Thermo Fisher Scientific offers lyophilization-compatible reagents and can lyophilize your assay for you. We will work with you to ensure your lyophilized assay retains the great performance of your original wet assay.

Benefits of lyophilization

Convenience: all reagents dried down in one reaction reduces the chance of pipetting error and saves time in the hands of the end user

Cost: eliminates the need for cold-chain shipping, significantly reducing costs; longer shelf life reduces waste due to product expiry

Stability: ship assays globally; they will arrive safely to your customers, even with potential hot temperatures or long distances

Shipping: because dried down reagents are room temperature stable, they can all be shipped together and kept at the same temperature

scheme

Why work with us?

By sourcing your reagents and your lyophilization services from the same supplier, you can drastically reduce the complexities in your supply chain. Your assay will be delivered to you, ready to go. We have heavily invested in our own lyophilization and manufacturing capabilities, so that you don’t have to.

Our products are manufactured in clean room facilities certified according to EU directives and ISPE guidelines, and in compliance with ISO 9001, ISO 13485, ISO 14001, OHSAS 18001 certification. Lyophilization is performed in environmentally-controlled rooms.

Optimizing your assay into a dry format

We work with you to optimize your assay with lyo-ready reagents and excipients in a wet format. Then, we begin manufacturing smaller amounts of lyophilized assay to ensure performance of the dry assay. Once the dry assay is optimized, we scale up manufacturing so that you can perform analytical and clinical validation on the dry assay.

Workflow
  • Confirm assay performance with lyo-ready reagents and excipients
  • Optimize assay and cycling parameters
  • Confirm lyophilized assay performance
  • Lock down assay formulation, specifications and test parameters
  • Confirm and document that the test works as intended
  • Confirm the clinical validity, utility, sensitivity and specificity of the test
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