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 Baghbaderani
Global Head of Process Development
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.
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.
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.
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:
- Best-in-class full package assay development services
- Established, pre-developed and fast-qualified assays for your therapy
Our locations
Process Development Laboratories
Cell and Gene
Related Insights
Related Offerings
Regulatory expertise
Pathway to success in Regulatory filings
Extensive Regulatory Expertise
We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.
Dedicated Regulatory Affairs Contact
We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.
Keep Pace with Regulatory Thinking
Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.
Nucleofector® Technology
The application of systems biology and multidisciplinary approaches require that cells and model systems display in vivo like cellular functionality. This means that the future of cell transfection is in using primary cell types, and that transfecting these physiologically relevant cell types is typically a very difficult task using traditional methods. Additionally, when using relevant cell lines as model systems, the critical issues are to achieve reproducibly efficient transfection with high levels of viability while matching throughput capability with the number of transfections required at each project phase – from proof of concept, through to scale-up and screening-like approaches. With the Nucleofector® Technology primary cells and stem cells, as well as cell lines, can be consistently transfected at high efficiency.
Developed in 1998, the Nucleofector® Technology was introduced to the research market in 2001 as the first efficient non-viral transfection method for primary cells and hard-to-transfect cell lines. Since then the technology has evolved through constant innovation (see history).
Looking for superior transfection performance?
- Electrical parameters are optimized to gain high transfection efficiency and retain high viability
- Excellent preservation of the physiological status of transfected cells
Relying on a proven and innovative technology?
- More than 4000 peer-reviewed publications and thousands of systems placed worldwide
- Modularity of the 4D-Nucleofector® System allows easy adaptation to new applications
- Invention of Nucleofection® Reaction of cells in adherence
Easy-to-use technology?
- More than 650 cell-type specific protocols lead to direct transfection success with a multitude of different cell types
- Easy optimization protocols for cell lines and primary cells allow for quick and streamlined optimization of virtually any cell type
Using various cell numbers for different applications?
- Nucleofection® Reaction of 2 x 104 to 1 x 109 depending one device
- Transferability of protocol conditions from small to larger cell numbers with the 4D-Nucleofector® System
Excellent technical and applicative support?
- Highly-skilled scientific support team to assist you in your research
- Scientific Support Team members have a masters or PhD level education in biology, biochemistry or biotechnology
- Many of them have over 10 years experience in transfection support
Stretching the dimensions of your research?
- Explore complex systems by using the same conditions to deliver DNA, RNA, oligonucleotides, PNA, peptides or proteins
- Different device platforms fulfil your choice of sample throughput from 1 through 384 transfections per run including automated high throughput
Avoiding cross-contamination?
- Disposable, sterile Nucleofection® Vessels minimize the risk of cross-contamination with cell or substrate leftovers
The components of the Nucleofector® Technology
The Nucleofector® Technology relies on the combination of a Nucleofector® Device and cell specific Nucleofector® Kits.
- The Nucleofector® Device delivers unique electrical parameters. The electrical settings are pre-programmed for each optimized cell type and can be selected via the device or PC software. We offer three different device platforms plus an add-on device
- The Nucleofector® Kits contain a specific Nucleofector® Solution and Supplement, specified cuvettes, pipettes, and the pmaxGFP® Control Vector. All Nucleofector® Solutions provide a protective environment that allows for high transfection efficiency and cell viability, while helping to maintain physiologically relevant cellular functions. A collection of Nucleofector® Kits with optimized protocols for primary cells and cell lines is available
- Besides providing optimal Nucleofection® Conditions, Optimized Protocols offer comprehensive guidance, including tips for cell sourcing, passage, growth conditions and media, and post transfection culture
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.
Our TheraPEAK® Products are supported by TheraPEAK® Regulatory Support Packages calibrated to customer requirements.
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.
