04.15.25 -- Regulatory-CMC: A Core Practice For Successful CDMO Partnerships

We know how tough it can be to find the right CDMO, especially when capacity is tight and timelines are critical. That's why we're bringing together 31 CDMOs for our Outsourced Pharma Capacity Update Partners Week — a chance to explore their latest capabilities and available capacity, all from the convenience of your screen. Learn more about our sessions grouped by modality to join us to find the right partner for your project.

Early product characterization can serve to uncover crucial information about an advanced therapeutic candidate, affording new insight into its CQAs and helping to shape better analytical assays.

This article, the first in a two-part series, focuses on the initial stages of product development — specifically, how to move from candidate selection to a Phase 1 IND application.

As the landscape of CAR T-cell therapies evolves, these treatments are becoming more precise in targeting cancer cells and overcoming production challenges, and are poised to revolutionize oncology.

AI doesn’t follow predefined logic like traditional software. Here's a tool, including a downloadable template, to answer critical compliance questions quickly.

Learn how CDMOs can drive transformation in the supply chain and create a more sustainable future for the pharmaceutical manufacturing industry.

Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.

By leveraging cells equipped with an existing TARGATT™ landing pad, we demonstrate how inducible expression can be efficiently achieved within just 4-6 weeks after donor plasmid creation.

We offer comprehensive analytical support across the R&D space, including method development, validation, process characterization, in-process testing, process validation, and GMP release testing.

The streamlined AAV transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development.

Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

Here we introduce the structure and capabilities of our Laboratory Services group, a cornerstone of our commitment to excellence in pharmaceutical development.

Let us help strategize your therapeutic development, design and execute experiments, manage production, and assist with regulatory documents and agency interactions.

As a CDMO Partner for Life™, our goal is to advance your cell therapies from lab to commercial scale, leveraging our cell and gene therapy expertise and global cGMP network.

For program management, project management, and more – you can count on CAI’s PPM team to deliver resources that will meet your internal stakeholders’ expectations.