Every step in automated cell manufacturing on the CliniMACS Prodigy can be adapted to your specifications. In-process and quality control procedures via flow cytometry can also be tailored on a MACSQuant® Analyzer using Customized Express Modes for automated data analysis. Explore your options.
We serve both internal and external customers. See what they appreciate about collaborating with the Customized Applications Services team.
Our Customized Applications Services team manages every step of translating a manual manufacturing process into a fully automated workflow on the CliniMACS Prodigy. First, we develop an RUO process development Customized Application that maintains flexibility and optimization options to find ideal process settings.
In a second-tier project, the RUO process development Customized Application can be transferred to a verified GMP-supportive Customized Application, including installation, operational qualification and phase-appropriate documentation. The GMP-supportive Customized Application can be integrated into clinical manufacturing processes after customer validation.
International quality standards (ISO) exist to guarantee consistency and reproducibility. We are certified and regularly audited to these standards as a commitment to our customers so that your custom product is delivered the same way every time.
You can be confident in our ability to manufacture software products and components reproducibly and provide the required quality documentation.