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.

Learn more

Dev-on-Demand

 

Well-defined, small packages of ready-to-go development work 

Tap into our scientific team’s knowledge, expertise and capabilities for specific challenges, trouble-shooting or individual development steps to advance your process and analytics.

Learn more

Why work with us?



We want to be your partner and drive pioneering therapies to the market. We invest heavily in enabling technologies and building expertise to support development and commercialization of your innovative therapies. Our scientists and engineers have decades of development experience across a broad spectrum of cell types and technologies. This forms the backbone of an extensive service offering, providing you with tailored process and analytical development, GMP manufacturing and regulatory services.


Watch the full video

Diagnose to de-risk

Develop & industrialize

Deliver to GMP

Asset 1
Asset 2
Asset 3
Asset 2
Asset 5

A step-by-step approach to commercial readiness

We have implemented a distinct model to ensure successful manufacturability and a clear path to clinical and commercial readiness for introducing new projects. This phase appropriate, 3-step approach is designed to enable our clients to efficiently reach their next milestone without compromising on the future requirements for a commercially viable process.

  • We start by diagnosing to de-risk the path to manufacturing, through establishing the baseline process, identifying the major manufacturability gaps and building true partnership with clients to define the scope of development activities.
  • Next, we develop and industrialize the process, where phase-appropriate process and analytics optimization occurs based on manufacturing design specifications and critical quality attributes.
  • Finally, we run the manufacturing process from end-to-end, at the appropriate scale to evaluate and confirm process robustness. We also work with our Manufacturing Science and Technology (MSAT) and operations teams to kick-off the activities for delivery of the process and analytics into GMP manufacturing suites.

Diagnose to de-risk

We establish the baseline process, perform a manufacturability assessment and identify the major gaps in the process and analytics, so that we can further define the full scope of development activities of the next step.

Develop and industrialize

We perform process and analytics development as well as optimization studies, based on the manufacturing design specifications and potential critical quality attributes.

Deliver to GMP

We run the manufacturing process from end-to-end at the appropriate scale to evaluate and confirm process robustness. We also work with the Manufacturing, Science and Technology (MSAT) and operations team to start transferring the manufacturing process into GMP suites, starting with pilot and training runs.

Analytical development and bioassay services

Product characterization is a highly complex cornerstone in the development of scalable cGMP manufacturing processes for cell and gene therapies. It requires modelling all of the mechanisms of action associated with the product, identifying the Critical Quality Attributes (CQA) of the product in relationship with the Critical Materials Attributes (CMA) and Critical Process Parameters (CPP). In some cases, this is critical to manufacturing high quality product and meeting safety and therapeutic efficacy requirements.

We offer two main strategies for your bioassays development to achieve successful product characterization towards GMP manufacturing:

  1. Best-in-class full package assay development services
  2. Established, pre-developed and fast-qualified assays for your therapy

Learn more about these strategies

Cell and Gene
Related Insights
Regulatory expertise
Pathway to success in Regulatory filings
Nucleofector® Technology

TheraPEAK® Media

TheraPEAK® Products help accelerate your development timelines and achieve at-scale manufacturing of therapies, so you can rapidly bring them to the patients.

Our scalable solutions for drug discovery to GMP manufacturing ranging from cell culture media and reagents for expansion of hematopoietic cells, AAV production to GMP grade consumables for our Nucleofector® Transfection Technology are built on performance, process expertise, and quality to support scalable manufacturing.

Access the proven reliability and quality of products used in FDA-approved therapies and more than 130 clinical trials across the globe to advance your cell and gene therapy processes.

Learn more

Careers

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 - Global Head of Process Development 
Behnam Ahmadian Baghbaderani

Vice President, Sales and Program Management, CGT Business Unit