We take on your development and manufacturing project needs, supporting your project with strategic consulting services that deliver a Program Scope Development plan fit for purpose for your individual CGT’s development and commercialization goals. Following our collaborative approach, we have supported dozens of cleared INDs, from first-in-human to pivotal phase, including full process development, co-development, tech transfer, and GMP-compliant manufacturing.
We provide support from pre-clinical strategy to pivotal phase clinical manufacturing with commercialization in mind. Together with you, we create a Quality-by-Design-focused program roadmap where we monitor all project milestones to ensure the success of your project. We use standardized tools, predetermined processes, dedicated platforms, and qualified materials that lead to a path to an IND in months, not years.
We support early proof-of-concept and feasibility studies for customers that want to evaluate the suitability of our integrated platforms and their efficacy in supporting their specific applications. We use our unique access to the latest product lines and pre-release products from Miltenyi Biotec to enable early adoption of our technologies. If there are specific requests or project needs, third-party equipment or process components can be considered at this stage. If comparability studies or specific material considerations are required, we review that information prior to initiating process development tasks.
We leverage our CliniMACS® Platforms to bring your therapeutic pipelines to the clinic and beyond. From standardized processes to customized applications, we can enable clinical translation in partnership with the global Miltenyi organization. From process industrialization through to pivotal phase clinical manufacturing, we keep scale in mind to reduce hurdles for late-stage platforms or processes.