Design & Development
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.
Process Industrialization
Smooth and efficient transition from R&D to full scale manufacturing is achieved through review of your processes by our experienced team. Careful review of your product and processes allows for delivery of a robust and scalable manufacturing workflow that avoids costly delays in product launches. Pilot lot builds are strongly encouraged and can be anywhere from 1-100 kits. This allows for the Launchworks team to dissect a builds workflow and identify any bottlenecks that may hinder success once full-scale commercialization is achieved. The product owner is then able to use the kits built to either generate early sales, promote as sample kits, or conduct internal validations/testing.
Supply Chain Development
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.
Product Sensitivity Testing
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.
Lyophilization Formulation
In partnership with Evik Diagnostics, LaunchWorks provides single-assay bead development services to extend the stability of your reagents. For more information on the benefits of incorporation of reagent lyophilization into your product see our white paper on the subject. This development service includes pilot lot batching and performance testing of lyophilized components. Often sensitive components contain the cryoprotectant Glycerol, which must be removed prior to lyophilization. Launchworks offers glycerol removal and quantification services, to best prepare your product for lyophilization. Accelerated and real-time stability, freeze/thaw stability, as well as many other studies, are done on the material pre and post lyophilization.
Post-Launch Optimization
Reduce bottlenecks through this cost-saving measure. We will help optimize your post-launch processes with the use of lyophilized reagent formats, buffer formulation optimization, and supply chain scaling. Shipping stability and packaging validation and improvement services are also key to keeping a product lifecycle successful. Launchworks aims to be the one-stop-shop partner for our customers even after their product is in the end-user hands.
Testimonials
Out of three vendors we use, one is cGMP, you have no errors & the others had several.
We went with LaunchWorks because you had the better solution. Every department was very pleased with the partner experience, including operations, R&D and marketing!
Your people demonstrated they were excited about the project and wanted to do the work! We also like that you have a culture of continuous improvement and LEAN manufacturing methodologies.
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