Our partners are pushing the limits of molecular biology and genomics.
Industry-leading assays require best-in-class reagents. Watchmaker’s deep domain expertise in computational biology, genomics applications, high-throughput enzyme engineering, and large-scale enzyme production enables us to address unmet needs with respect to throughput, performance, scalability, and consistency of supply. Our in depth enzyme characterization techniques and multidimensional Design of Experiments (DOE) approach to optimization provide unprecedented insight into the tunable system variables critical to delivering highly customized performance in specialized applications.
Our Quality Management System is designed to ensure robust compliance to the ISO13485 Standard (3rd edition, 2016), while enabling the design and development agility needed to be responsive to customer requirements and timelines.
The OEM Solutions team has decades of experience customizing solutions for a wide range of diagnostic and life science applications and understands the value of collaborative, cross-functional relationships. We are uniquely suited to provide the insights, agility, and scalability required to fuel high-growth business partners of all sizes.
OEM Products
Our OEM portfolio comprises best-in-class industrial enzymes, functional modules, and application-specific kits, developed and produced within an ISO 13485:2016 certified QMS to meet the most stringent end-user requirements. Our portfolio includes:
Complete NGS solutions
- Reagent modules for enzymatic fragmentation of DNA, ligation-based DNA library preparation, and NGS library amplification
- Complete kits for library preparation from ctDNA, FFPE, blood, saliva, cell lines and other inputs for whole-genome and targeted sequencing (hybridization capture or amplicon sequencing)
Precision Enzymes
- DNA Ligases and other DNA and RNA modifying enzymes
- Thermophyllic and mesophyllic DNA polymerases
- Reverse Transcriptases
- phi 29 DNA Polymerase
Custom Solutions and Services
As a Watchmaker OEM Business Partner, you will benefit from a range of concierge services, designed to help streamline your operations, control cost, and ensure supply chain security:
Single-lot Shipments
- Co-ordinated manufacturing ensures single-lot deliveries for all shipments
- Minimizes potential lot-to-lot variability and frequency of mandatory reagent revalidation
- Improves traceability for products used across multiple sites
Kit-based lot testing
- Application-relevant testing of complete kits or workflow modules comprised of single component lots
- Acceptance criteria confirm performance of individual components, and directly reflects performance of the whole kit
in the end-user context
Custom Certificates of Analysis
- Detailed, lot-specific CoAs confirm that all predetermined product release and quality specifications have been met
- CoAs may be customized to facilitate receipt of new OEM product lots
- Extended shelf life
Extensive pre-launch and ongoing post-launch shelf-life testing generate high-confidence product stability data
- Guaranteed minimum shelf life for every lot
- Pro-active forecasting and production planning reduces Watchmaker warehousing time, benefiting supply chain flexibility
and end-user satisfaction
Advance change notification
- Changes to product form, fit and/or function may be needed on occasion to maintain stringent quality standards and continuity of supply
- Advanced notification, multi-lot test materials, and collaborative obsolescence arrangements ensure operational stability and consistent assay performance
Custom kitting and formulations
- Custom labeling and kit formats (bulk packaging and customized kit component volumes) available
- Customization for buffer compatibility, glycerol free formulations, alternative enzyme concentrations, workflow and assay-specific product requirements
Our Commitment to Quality
Watchmaker Genomics is committed to developing and supplying innovative technologies for the reading, writing and editing of nucleic acids, to advance genomic applications in research and health.
We will achieve this by focusing on our customers’ needs, maintaining an effective quality management system, creating an environment for continuous improvement, consistently providing high quality products, and complying with regulatory requirements.