services

LaunchWorks offers design and development services in lateral flow, genomic diagnostics, and immunoassays. Our design and development process deploys a phase-based approach to best capture a products design history file, which is transferred to the customer, and allow for simple transition into manufacturing. Additionally, for those in need of Microfluidic device design we leverage our partnership with the Canadian National Research Council (CNRC) and their new LIFT incubator space.

LaunchWorks will establish baseline product performance and sensitivity parameters to create component specific guard bands, which allow for early detection and prevention of performance issues during manufacturing. Additionally, this service establishes the QC acceptance criteria for a product. This allows for a customer to build a component or entire kit, trend data points such as pH, conductivity, enzyme activity, etc, and track historically those criteria that are truly important to the function of the product. Guard-banding critical components allows the customer, and the CMO, to establish the process limits. The workflow for making 2 kits is vastly different than the workflow to make 200 or 2000 kits. These differences can affect a products performance and stability if not properly vetted prior to production onboarding. This also allows for sensitive and/or critical components to be called out in granular detail to ensure no mishandling.

Identify potential supply chain risks and work to mitigate potential problems through supplier auditing, secondary supplier qualification, and high lead-time raw material procurement. Our team can provide you with high quality alternate materials across multiple lots delivered for functional testing to demonstrate equivalency. Bill of Material, or supply chain, development is often overlooked during development, however, supply chain issues often lead to product launch failures. Small lot batching using alternative parts for product performance validation ensures that a product has the appropriate raw material redundancies to be successful once at full production scale.

Formulation of enzyme mixes, buffers, custom reagents, magnetic bead mixtures, transport medias.