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.

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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.

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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.

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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

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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.

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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 - Global Head of Process Development 
Behnam Ahmadian Baghbaderani

Global Head of Process Development