LaunchWorks CDMO services

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.

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.

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.

Filling into containers up to 250 liters in an ISO 13485 Quality Management System.