A standardized, systematic approach to tech transfers, manufacturing and pre-approval inspection readiness to reliably take your therapy to commercialization.

 

Once your process is established and ready to tech transfer, your next goal is to follow through with its successful commercialization. You want to ensure that your therapy will pass regulatory inspections and need a commercially viable manufacturing strategy flexible enough to adjust to varying patient demand.
Achieving these goals can be challenging when you are one of the trailblazers in an emerging market where only a few products have been approved. There is a lot of uncertainty around pricing, on the commercial viability of cell and gene therapies, while new biotech innovators are constantly popping up, competing for the same indications.
Meanwhile, regulators are making it abundantly clear that despite accelerated pathways and revolutionary efficacy, there will be no special treatment for cell and gene therapies’ approvals compared to traditional biologics. Complying with all safety and quality standards takes highly trained and experienced dedicated teams. Yet, the rapid growth in the CGT sector has led to a scarcity of talent.

 

 

Follow a proven, predictable path to take your product to market by leveraging a standardized, structured and systematic approach to manufacturing

Our New Product Introduction (NPI) program maps out your entire journey to commercialization, accounting 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, combining both corporate and local quality standards, customized for cell and gene therapies to de-risk your journey to commercialization.

You will also maintain complete oversight during your product’s lifecycle journey, enabling you to assess and validate the quality of process robustness, raw materials, analytical methods, sterility, facility, equipment, and tissue acquisition throughout this journey.

 

Anticipate and address potential regulators observations by focusing on your therapy’s manufacturing process

Our established, compliant facilities and processes enable you to leverage facility layouts, airflows, material storage, documentation processes and quality systems which have already proven to be suitable for commercial manufacturing and passed regulatory agency inspections for other cell and gene therapies.

As a result, you can focus on your product’s manufacturing process to withstand the scrutiny of regulatory inspections, while relying on us to complete the regulatory compliance checkpoints for the facility where it is hosted. And by minimizing risks to commercialization in this way, you’ll be able to avoid major rework, delays, and related costs that could lead to a catastrophic business loss

 

Ramp up and build out within an established infrastructure

With scalable capacity in state-of-the-art facilities, you’ll be able to commission GMP-certified suites and Lonza engineers to build them to your precise specifications.

This means you’ll be able to adapt more efficiently and reliably to meet changes in demand—without incurring in-house related capital and operating expenses. In the end, you’ll be able to deploy a high-yield, low-failure model for commercialization.

 

Our capabilities

Our cGMP manufacturing capabilities span three technologies – autologous and allogeneic cell therapies and viral vector gene therapy. Our footprint spreads across 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 optimized path to market
Manufacturability assessment  Global cGMP manufacturing capacity across 3 continents Tissue acquisition services, Cell and viral banking
Process improvement & development Global tech transfers Customized business and operation models, facility build-out
Analytical assay development, qualification & validation Commercialization readiness Quality and regulatory set up for successful commercialization
 Media optimization & development Formulation & fill / finish Regulatory consulting and services
Formulation & fill / finish Storage & distribution

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 TherapyAutologous 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

Portsmouth, NH, USA

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing

101 International Drive
Portsmouth, NH 03801
United States of America (the)

Singapore (Mammalian and Cell & Gene Technology)

Production, Sales & Support

Lonza Biologics Tuas Pte Ltd
Lonza Bioscience Singapore Pte Ltd
35 Tuas South Ave 6, Tuas 637377
Singapore

Houston, TX, USA

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Viral Vector Manufacturing

14905 Kirby Dr
Houston, TX 77047
United States of America (the)

Geleen, The Netherlands

Clinical Manufacturing, Commercial Manufacturing, Cell and Gene Manufacturing, Process Development, Analytical Development

Urmonderbaan 20B
Geleen 6167 RD
Netherlands (the)

Lexington, MA, USA

Clinical Manufacturing

4 Hartwell Place
Lexington, MA 02421
United States of America (the)

Siena, Italy

Research & Development, Process Development

Strada Del Petriccio e Belriguardo 35
Siena 53100
Italy

Careers in cell & gene therapy at Lonza


We are looking for candidates to join our team across our global network of sites.

View opportunities