16 services found
LaunchWorks CDMO Services
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Manufacturing
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Pilot Lot Production 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 ...
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Tech Transfer Services
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 ...
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Custom Formulation Services
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 ...
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Kit Production Services
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 ...
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Finished Product QC Services
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 ...
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Critical Component QC Services
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 ...
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Design & Development
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Design & Development 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 ...
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Supply Chain Development Services
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 ...
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Lyophilization Formulation Services
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 ...
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Post-Launch Optimization Services
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 ...
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Formulation & Filling
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Testing
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Manual Filling Services
Filling into containers up to 250 liters in an ISO 13485 Quality Management ...
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Finishing Services
Labeling, bulk packaging or commercial packaging provided as needed. For products going direct to your clients, we offer fulfillment services as ...
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Formulation Services
Formulation of enzyme mixes, buffers, custom reagents, magnetic bead mixtures, transport ...
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Automated Filling Services
ISO 13485 automated filling into microtubes, specimen tubes and bottles (up to 60 mLs). Volumes as low as 10 uLs. Filling capacity up to 500,000 units per ...
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Real-Time Product Aging Services
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 ...
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Cold Chain Packaging Services
For custom cold chain shipping needs you can have engineered cold chain packaging development and validated through our affiliate company, ...