Custom services for GMP manufacturing

Customized assay development, formulations, and packaging services

One size does not fit all, and current commercially available products may just not work for you. Instead of investing tremendous amount of time trying to develop an assay in-house or find another solution that still isn’t really what you are looking for, let our experts tailor the right solution to your needs.

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We have an experienced analytical assay development team who fully understand the pharma QC needs, focusing efforts on process impurities and contaminants. With products like Applied Biosystems resDNASEQ Quantitative DNA assaysMycoSEQ Mycoplasma Detection assay and  ViralSEQ Detection assays, the team has a solid foundation to customize a solution that fits your needs. The team can also help optimize your sample preparation by developing solutions based on our Applied Biosystems PrepSEQ chemistry.

Our team can support a large variety of modifications of existing kits and components. Whether you need to optimize sample input, turnaround time, or throughput, out team will work with you to simplify every aspect along your process. That includes adjustments to existing kits or individual components or even special lot build and sizes with optimal expiration dating.

Custom assay development services

custom assay development services for in process and lot release testing

Sometimes, there just isn’t a solution available on the market, and that’s where we can help. Our experts can work with you to develop a custom TaqMan assay to meet your in-process and lot release testing needs.  Are you working with a unique host cell line? We can help you with the development and validation of a custom qPCR assay. Are you concerned with specific viral contamination? We can help you develop a targeted custom assay to test for it.

Our solutions can be developed to run on either the Applied Biosystems 7500 or Applied Biosystems QS5, giving you the flexibility to choose.

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Custom formulations

custom formulation services for in process and lot release testing

Your drug candidate may need a slight modification of our current assays to work in your process.  Customize the concentration of our quality components to ensure the assay performs to your validation requirements. We support you with changes to our concentrations or other adjustments needed to make our assays work for your needs.

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Custom packaging services

custom packaging services for in process and lot release testing

Do you want to change up a kit configuration? We can modify our packaging to give you what you want and leave out what you don’t. Our capabilities include:

  • Adjusted kit sizes or filling volumes of individual components
  • Large single lots for validation purposes 
  • Custom lot build and sizes 
  • Inventory and expiration date management 

Let us help you plan your assay inventory or expiration dates. Locking in a proven lot for long term stability is key – we will work with you to secure key custom assay packaging to help ensure a continuous manufacturing process. 

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Bioprocessing resources

Access a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing: