A well-defined CMC strategy is foundational to the successful development, manufacture, and regulatory approval of advanced therapies.
The use of synthetic oDNA as a starting material simplifies the CMC narrative and supports alignment across development, manufacturing, analytics, and regulatory planning.
Artis provides integrated CMC and regulatory consulting services to improve product quality and program readiness, reduce risk and accelerate timelines, and optimize development costs.
Quality by Design (QbD) principles focus on the early identification of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) to support robust development, scalable manufacturing, and regulatory readiness.
Early integration of QbD and regulatory planning helps guide development decisions and support efficient program advancement.
IND readiness requires aligned process development, analytical strategy, manufacturing readiness, and CMC documentation that can withstand regulatory scrutiny.
Artis integrates CMC, analytical, and manufacturing execution to generate the data, methods, and GMP materials that support IND submissions while reducing disconnects between strategy and execution.
Manufacturing support for development studies, characterization activities, and GLP toxicology studies.
Upstream and downstream process development to support robust and scalable manufacturing processes.
Analytical method development, characterization, and qualification to support IND submissions.
IND-enabling GMP manufacturing support for toxicology studies, clinical programs, and commercial readiness activities.
Integrated CMC planning supports early identification and mitigation of technical, manufacturing, analytical, quality, and regulatory risks, helping programs avoid delays, rework, and clinical holds.
Stem Cells 
CAR-T 
AAV Delivery 
LVV Delivery 
Other Viral Vectors 
Extracellular Vesicles 
Nanoparticles