LaunchWorks CDMO services

Our scientists and engineers will review your product requirements and produce quick iterative pilot lots of new, challenging, or high complexity products. This provides proof of transferability to our full production team while also lowering risks of potential unknown technical challenges in scale up.

Our trained project development and management teams will work with you to fully define your product specifications and process documentation to our standards. Allowing our precision manufacturing team to produce a product that exceeds your manufacturing objectives.

Whether a part of a larger kitted product or simply bulk format solution our process engineers will establish product specific work instructions that capture all of your formulation specifications while also providing increased quality assurance, material traceability, and elimination of your internal manufacturing risk.

With full traceability and product purity, our ISO-13485:2016 quality standards ensure all of your products are produced to your exact specifications including commonly overlooked items such as box label placement, component fulfillment into packaging or simply our critical eye for defects in raw materials.

For the most turn key production solutions we provide you the option to transfer your validated functional product QC tests to our qualified engineers and scientists. LaunchWorks immediately performs your lot release tests following production resulting in decreased logistical costs and lot release times. Upon completion of this testing we provide detailed reports of the results back to your quality team for final review and product release.

Lack of necessary quality control critical product can lead to missed deadlines and exceeded budgets. Launchworks will work with you to identify critical components through the validation of your incoming materials, supplier audits, as well as raw material shipping and receiving stability.

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.

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.

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.

Real-time aging is performed in parallel with accelerated aging to provide stability data that allows you to empirically determine your product shelf life in real time.