cGMP Manufacturing

Need help with cGMP manufacturing?

global cell & gene therapy manufacturing

The world of cell and gene therapy is expanding rapidly, with ever-growing market opportunities for pioneering new treatments. However, it can be difficult to commercialize new therapies given the costs involved, regulatory hurdles and scalability challenges. Drug developers need reliable, efficient and cost-effective manufacturing services with the flexibility to scale up production as needs develop.

We can work with you to overcome these challenges. With leading-edge technologies and expertise, we can help you develop and commercialize your innovative new therapy. Our scientists and engineers bring decade-long development experience across a broad spectrum of cell types and technologies. With this background, we can tailor our services in process and analytical development, manufacturing and regulatory support to meet your needs.

Our cGMP manufacturing capabilities span three technologies – autologous and allogeneic cell therapies and viral vector gene therapy. Our footprint is spread over four centers of excellence in three continents, by supporting you at all stages of clinical development and commercialization, we can help you drive your pioneering therapies to market.

Preclinical and early phase	Late phase and commercial	Support for optimizes path to market
Manufacturability assessment	Global cGMP manufacturing capacity in 4 centers of excellence across 3 continents	Tissue acquisition services & MCB / WCB / MVB*
Process improvement & development	Global tech transfers	Customized business and operation models, facility build-out
Analytical assay development, qualification & validation	Formulation & fill / finish	Quality and regulatory set up for successful commercialization
Media optimization & development	Storage & distribution	Regulatory consulting and services

Why Lonza:

Access to distinguished company with 40 years of deep heritage in biologics manufacturing and 20+ years of cell and gene therapy GMP expertise

See our specific experience with Allogeneic Cell Therapy, Autologous Cell Therapy and Viral Vector Gene Therapies

Over 1,000 employees globally and growing

State-of-the-art facilities in 3 continents of the world
Experience with various scale-up/out methods, platforms, tools and technologies

Regulatory support from pre-IND all the way to commercialization

cell and gene therapies

our global network

Our global network of four centers of excellence spans across three continents: Our sites in Portsmouth, NH (USA) and Singapore (SG) provide clinical and commercial manufacturing, while Pearland, TX (USA) and Geleen/Maastricht (NL) offer integrated cell and gene therapy services that include process/analytical development, as well as clinical and commercial manufacturing.