Accelerate your path to IND, secure your CMC journey and increase your chances of success in the clinic all-in-one, by leveraging one of the most experienced teams in taking cell and gene therapies from discovery all the way to commercial launch.
Tap into our scientific team’s knowledge, expertise and capabilities for specific challenges, trouble-shooting or individual development steps to advance your process and analytics.
We want to be your partner and drive pioneering therapies to the market. We invest heavily in enabling technologies and building expertise to support development and commercialization of your innovative therapies. Our scientists and engineers have decades of development experience across a broad spectrum of cell types and technologies. This forms the backbone of an extensive service offering, providing you with tailored process and analytical development, GMP manufacturing and regulatory services.
Diagnose to de-risk
Develop & industrialize
Deliver to GMP
We have implemented a distinct model to ensure successful manufacturability and a clear path to clinical and commercial readiness for introducing new projects. This phase appropriate, 3-step approach is designed to enable our clients to efficiently reach their next milestone without compromising on the future requirements for a commercially viable process.
We establish the baseline process, perform a manufacturability assessment and identify the major gaps in the process and analytics, so that we can further define the full scope of development activities of the next step.
We perform process and analytics development as well as optimization studies, based on the manufacturing design specifications and potential critical quality attributes.
We run the manufacturing process from end-to-end at the appropriate scale to evaluate and confirm process robustness. We also work with the Manufacturing, Science and Technology (MSAT) and operations team to start transferring the manufacturing process into GMP suites, starting with pilot and training runs.
Product characterization is a highly complex cornerstone in the development of scalable cGMP manufacturing processes for cell and gene therapies. It requires modelling all of the mechanisms of action associated with the product, identifying the Critical Quality Attributes (CQA) of the product in relationship with the Critical Materials Attributes (CMA) and Critical Process Parameters (CPP). In some cases, this is critical to manufacturing high quality product and meeting safety and therapeutic efficacy requirements.
We offer two main strategies for your bioassays development to achieve successful product characterization towards GMP manufacturing:
The application of systems biology and multidisciplinary approaches require that cells and model systems display in vivo like cellular functionality. This means that the future of cell transfection is in using primary cell types, and that transfecting these physiologically relevant cell types is typically a very difficult task using traditional methods. Additionally, when using relevant cell lines as model systems, the critical issues are to achieve reproducibly efficient transfection with high levels of viability while matching throughput capability with the number of transfections required at each project phase – from proof of concept, through to scale-up and screening-like approaches. With the Nucleofector® Technology primary cells and stem cells, as well as cell lines, can be consistently transfected at high efficiency.
Developed in 1998, the Nucleofector® Technology was introduced to the research market in 2001 as the first efficient non-viral transfection method for primary cells and hard-to-transfect cell lines. Since then the technology has evolved through constant innovation (see history).
The Nucleofector® Technology relies on the combination of a Nucleofector® Device and cell specific Nucleofector® Kits.
TheraPEAK® Products help accelerate your development timelines and achieve at-scale manufacturing of therapies, so you can rapidly bring them to the patients.
Our scalable solutions for drug discovery to GMP manufacturing ranging from cell culture media and reagents for expansion of hematopoietic cells, AAV production to GMP grade consumables for our Nucleofector® Transfection Technology are built on performance, process expertise, and quality to support scalable manufacturing.
Access the proven reliability and quality of products used in FDA-approved therapies and more than 130 clinical trials across the globe to advance your cell and gene therapy processes.
Vice President, Sales and Program Management, CGT Business Unit