Successful Pre-Licensing Inspections passed by our sites for Cell & Gene Therapies
The Early Advantage
Your IND Submission in Safe Hands
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.
Diverse by nature – experts by design
Cell & Gene therapies spread across a wide range of modalities. As the leading CDMO in this space, we are constantly investing and developing our extensive experience across this broad spectrum, including emerging new modalities, to provide you with the expertise you need for your therapy.
Phase-appropriate services
We offer a complete suite of services to support your project from concept to clinic, including cell line development, process development, cGMP manufacturing, regulatory support from our dedicated cell & gene regulatory team, tissue sourcing and acquisition and logistics.
Customized Cell & Gene technologies for cGMP manufacturing
While we pride ourselves in being fully technology agnostic for our customers, our proprietary cell & gene therapy manufacturing technologies are always available to our customers, at any stage of development.
Overview
Our experienced team of scientists and engineers work closely with you to ensure seamless project execution and regulatory compliance. We are committed to delivering high-quality products and services that meet your exacting specifications and timelines.
Choose Lonza as your CDMO partner for your cell and gene therapy development and manufacturing needs. Contact us today to learn more about our services and how we can help bring your therapy to market faster.
Our state-of-the-art facilities and high quality control processes also ensure that your product is manufactured to the highest standards.
Our approach to develop and manufacture your therapy from concept to commercialization and beyond
Our New Product Introduction (NPI) and Lifecycle program, maps out your entire journey to commercialization. It accounts for each key milestone with checkpoints, to ensure you meet all required quality standards as your therapy progresses towards commercialization. The NPI program leverages our heritage and longstanding experience in establishing cGMP manufacturing standards. It combines both corporate and local quality standards customized for cell and gene therapies, to de-risk your journey to commercialization.
After working with several CDMOs, Lonza is head and shoulders above the rest. Client success relies heavily on CDMO competency, trustworthiness, transparency, follow-up and follow-though. Lonza MFG, MSAT, QA, QC and Supply Chain worked tirelessly together to deliver our GMP product and deliver it on time. They were a great partner and seemed to lose just as much sleep as we did navigating the processing and testing challenges that come with taking a clinical program to the next phase."
- A CGT Customer
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By joining Lonza, you will get to work with some of the world’s top experts in the space, while developing advanced therapies with a potentially life-saving outcome.
Behnam Ahmadian Baghbaderani
Global Head of Process Development