Analytical/CMC

Accelerate your biologics journey with our comprehensive analytical and chemistry, manufacturing and controls (CMC) CDMO solutions. From method development to product characterization and stability studies, we drive the rapid advancement of your biologics innovations.

How can our analytical and CMC solutions help you?

Our deep expertise spans a wide range of complex biologics, allowing us to develop robust CMC strategies and ensure product quality and regulatory success throughout their lifecycle.

We provide critical insights through a full suite of services, including analytical method development, product characterization, process screening, and bioassays. With our advanced analytical technologies and a deep understanding of regulatory requirements, we streamline development timelines and safeguard the long-term stability and efficacy of your biologics.

 

Why partner with Enzene for analytical and CMC services?

We are a global CDMO and biosimilar developer dedicated to impacting the global healthcare landscape by bringing trusted and affordable medicines to market, quickly.

Committed to innovation, we leverage cutting-edge analytical technologies and a deep understanding of regulatory pathways to optimize your CMC strategy. Our expertise allows us to deliver robust data packages, significantly reducing development risks and accelerating your time to market.

Our fully-integrated services and productive pipeline of biosimilars are designed to cater to your project’s every need.

Discover EnzeneX™

A platform that pushes your project further

Achieve higher yields and significantly lower costs with our patented continuous bioprocess manufacturing platform — designed to drive innovation and optimize efficiency in biologics production.

EnzeneX™ harnesses the power of intensified perfusion using alternate tangential flow (ATF) and automated multi-column chromatography to achieve the continuous production of your biologics.

Designed for efficiency and cost-effectiveness, EnzeneX™ enables uninterrupted loading and processing of materials, delivering superior product quality and manufacturing outcomes.

Join the revolution

Fueled by our continuous innovation and armed with EnzeneX™, our fully-integrated CDMO solutions are designed to help bring your biologics innovations to life.