Assay Development

An antibody is only useful if the assay you are using is appropriate for your antigen. Assay development is often a challenge and time consuming. But reliable, robust assays are key to every phase of pharmaceutical development. Developing immunoassays are usually used for antigen detection, analysis, or quantification. Assay development begins with the design goals which you provide.

•	Establish assay parameters
•	Evaluate preliminary reagent stability
•	Determine detection limits
•	Data review
•	Develop prototype for evaluation

Put Millipore’s extensive experience in assay design, validation, and production to work for you. Our GMP manufacturing environment utilizes accepted design controls, ensuring that your resulting assay will be developed systematicaslly, thoroughly documented and readily transferred to Iargescale screening and lot manufacturing. Our custom assay development team will communicate results in a timely manner, tailoring development to meet your requirements and giving you the freedom to focus on your work. Assays are available with colorimetric, fluorescent, or bioluminescent readouts for improved sensitivity and dynamic range.

Assay development begins with the design goals provided by you – alternatively, design goals can be generated through a joint development program. If all of the components are available, then the assay development proceeds quickly. Alternatively, Millipore can supply reagents,work with outside sources, or develop new antibodies, antigens, or nucleic acids to meet your assay requirement needs. Once the assays are developed and documented, we can provide large scale manufacturing or ensure a complete technology transfer to your facility. Reliable, reproducible assays are the main objective. Assay validation and standardization services are available.

Pilot Studies

•	Conjugation with detection molecules
•	Determine ability to detect target
•	Develop assay format

Assay Development

•	Establish assay parameters
•	Evaluate preliminary reagent stability
•	Determine detection limits
•	Data review
•	Develop prototype for evaluation

Assay Validation

•	Determine reagent stability
•	Measure inter and intra-assay variability
•	Screen with samples

Production Transfer and Kit Production

•	Write specifications
•	Provide complete technical transfer

Bioluminesence Labeling Ultra Sensitive Detection with Aqualite

AquaLite® is a sensitive bioluminescent label for universal use in assays and conjugations.

AquaLite® is available for custom conjugation to any antibody or fragment, as well as to streptavidin, biotin, or any oligonucleotide. Millipore can also design a custom assay using

AquaLite® ultra-sensitive detection.

For questions or comments please contact our specialized Custom Service Team at Millipore Corporation. Request a quote for Custom Services or Bulk Services

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