Considerations when developing diagnostic assays using leading-edge technologies
Advanced technologies are taking in vitro diagnostics (IVD) far beyond lateral flow tests or immunoassays. Molecular technologies like PCR and NGS are rapidly expanding in the diagnostic assay development field auguring a new era of DNA and RNA IVD tests. Rapidly evolving tests based on innovative CRISPR gene editing are changing the point-of-care approach to diagnostics in the clinic. However, development of IVDs based on novel technologies is proving to come with its own considerations and hurdles not seen in traditional assay development.
Here, Merck discuss the unique challenges and strategies for utilizing emerging technologies in IVD assays and how a contract manufacturing organization (CMO) partner can help.
Download this White Paper now
In this White Paper, understand how a CMO can:
- Validate and ensure supply of bench-to-production material
- Ensure raw material integrity
- Maintain flexibility
- Confirm access to the necessary intellectual property
- Know the necessary ISO certification level
- Understand that scale-up is not always linear
- Understand regulatory requirements for both raw materials and the final product
- Ensure universality
- Be realistic about timelines and anticipate changes
- Prepare for commercial success
And much more!
This content was provided by Merck.
The life science business of Merck operates as MilliporeSigma in the USA and Canada
