Control and Panel Development
30 years of experience in custom solutions
At SeraCare, we are dedicated to developing diagnostics solutions to meet the unique needs of our customers. From custom validation panels to in-kit controls for in vitro diagnostics, we can deliver the high quality and performance that you require. Our project management and R&D teams are focused on one thing: delivering the tools you need to build industry leading assays.
We understand that your business partnerships depend on expertise, quality and a commitment to your success. Our custom product collaborations are based on our appreciation of the needs of assay developers, process engineers and clinical labs. We can help bring your custom products to market and shorten assay adoption timelines.
Our experience throughout the IVD cycle will help you to:
- Bring your assays to market more quickly
- Control product development costs
- Improve your design and development efficiency
- Anticipate the needs of clinical end users
Control development services
Focus on assay design and validation, and leave the development and production of your diagnostic controls and reference materials to SeraCare. Our team has worked with many of the leading assay manufacturers worldwide and has extensive experience with serology and molecular applications, including next-generation sequencing and digital PCR. With novel technologies such as AccuPlex and Seraseq, and our VariantFlex library, we have the flexibility to build products for advanced diagnostics according your unique specifications.
Partner with SeraCare to develop specialized validation kits to aid in the adoption of your new assay. Speed the time it takes your customers to validate and adopt new instrument platforms, accelerating assay revenue from clinical sites with a plug and play solution. With a custom designed panel, packaged into one concise kit, your end-users will have a dedicated source of validation and training material to rapidly adopt your new assay into their laboratory.
Custom manufacturing and packaging
Gain speed and reduce risk working with a partner with robust quality systems and a deep understanding of the regulatory landscape. SeraCare can meet your manufacturing and packaging specifications.
- Broad manufacturing and service capabilities
- Batch manufacturing with large lot capacity
- Design and scale up support
- Custom vialing
- Product fill and packaging