IVD & Molecular Dx

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Learn how our GMP & Commercial Services group can work with your development teams to design and deliver individual custom, GMP-compliant critical oligonucleotide components or fully finished diagnostic kits.

Trusted Oligonucleotide Component Manufacturer for Diagnostic Assays

With over 20 years of experience in oligonucleotide synthesis, chemistry manufacturing, and instrumentation, Biosearch Technologies has established itself as a reliable business partner for providing oligo components for in vitro diagnostic suppliers. Our state-of-the-art laboratories, superior quality reagents, GMP compliant standards, and fully customizable, yet consistent production processes, make Biosearch the partner of choice for diagnostic test manufacturers.

Benefits and features that Biosearch Technologies has to offer:

Simplify technology licensing requirements
Choose from the largest selection of oligonucleotide modifications available
Minimize large and multiple capital investments
Scalable manufacturing tailored to your needs
Rely on Biosearch’s extensive experience across all phases of manufacturing
Manage regulatory constraints
Accelerate the development of your molecular diagnostic project

Biosearch Technologies provides synthesis, formulation, and packaging to accelerate assay development from conception to commercialization. We can satisfy all your dye selection, oligo modification and special manufacturing demands for high quality IVD oligo components.

Proprietary Fluorophores and Quenchers

Since our introduction of the Black Hole Quencher® (BHQ®) dyes in 2000, BHQ dyes have become the dark quencher of choice in the DNA marketplace. Other proprietary dyes include the CAL Fluor® and Quasar® dyes, which are vibrant, high performing fluorophores designed to perfectly complement the BHQ dyes. Biosearch can also manufacture many other dyes such as FAM, TET, HEX, JOE, etc., to supply any combination of fluorescence-quenched probes. Learn more about our proprietary dyes

Licensing Programs

Biosearch Technologies offers flexible and different levels of licensing programs that can be tailored to the terms of your project. Partner with Biosearch so you can consolidate your oligo supply and dye licensing needs. Contact licensing@biosearchtech.com with any related questions.

Experience and Technical Excellence in Synthesis

Biosearch Technologies manufacturing services offer oligo components for every phase of product development GMP Product Development

Custom Oligos for Research - Custom-synthesized oligos offered at low prices with the quickest turnaround; ideal for assay design.
PilotDx™ Oligos - The cheaper and faster alternative to GMP-grade oligos. PilotDx oligos are accompanied with Certificates of Analysis released by QA and are ideal for product development, especially in the medical device arena. Visit our PilotDx Oligo webpage for more details.
GMP Oligos - Oligo components for molecular diagnostic assays with defined batch record documentation released by QA; manufactured under controlled processes.

State-of-the-Art Production Facilities

A vertically integrated structure allows Biosearch to precisely control the raw materials and manufacturing process, reducing costs and turnaround time. These advantages and Biosearch’s ability to manufacture diagnostic components containing BHQ dyes make Biosearch Technologies the ideal partner for medical device development.

Our synthesis skill set includes:

Fluorogenic probes and primers to fuel various platforms such as: real-time qPCR thermal cyclers, Luminex®-based systems and isothermal amplification
Synthesis scales ranging from 25 nanomole to several millimole
Unmodified oligos as long as 200 bases
Synthesis of oligos with a vast selection of modifications, RNA, DNA-RNA hybrids, and other complex and rare specialty bases

IVD Purification Lab Whether you need HPLC purified oligos mixed and normalized in custom buffers, or bulk oligos, Biosearch can deliver. We offer a variety of purification options and highly customizable formulation and delivery specifications tailored to your product requirements. Please request our recently revised Contract GMP Manufacturing Brochure for more details.

Quality Management

The Biosearch Technologies Quality Management System (QMS) is designed for compliance to ISO 9001:2008. Additionally, processes and procedures within IVD oligo production comply with requirements of 21 CFR Part 820 (as applicable). Our QMS documentation results in reproducible components that consistently meet the needs of our clients. Our production batch records provide full process traceability and undergo systematic scrutiny during Quality Assurance review and release.

Please request our recently revised Contract GMP Manufacturing Brochure to learn more about our standard quality control (QC) release methods and the functions of our Quality Assurance (QA) team.

Customer Service

Biosearch Technologies has a GMP project management team dedicated to providing personal consultation and support through every phase of your diagnostic product. For each product, we can:

Discuss product details such as sequences, purity, synthesis scales and delivered amounts, chemistry, manufacturing and QC specifications, regulatory requirements, lead time, IP, etc.
Support your Quality and Regulatory staff with FDA submissions by assisting with risk assessment, validation documentation, stability studies, etc.
Provide help with oligonucleotide design, assay development, or application usage
Give regular updates on the current production status

For questions about the services we offer for molecular diagnostics, please e-mail info@biosearchtech.com or call us: 1.800.GENOME.1 (436.6631).

Download Brochure

Learn more about Biosearch's GMP and Commercial Services by requesting a brochure.