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Building Bridges from Research to Therapy

Lonza’s Pluripotent Stem Cell Innovation Center focuses its efforts in two main areas – technology development and services.  In our development programs, we have three priority projects – reprogramming, cell culture system, and differentiation.  Each of these technologies is being developed with the needs of the translational researcher and cell therapy client in mind.  Each of these technologies is qualified to the highest standard and can be used in our cGMP compliant facilities.

 

Focus area image for PSC

 

Lonza Bioscience has built up expertise, capacity, and capabilities in pluripotent stem cell research and their application to cGMP manufacturing.  Researchers can now access this expertise through our PSC service offering from iPSC generation to process development and differentiation.    

We provide the following:

  • Experience - Team of 15 highly trained hESC/iPSC researchers plus additional personnel dedicated to process development & cGMP manufacturing.
  • Capacity - Dedicated facilities (cGMP/non-cGMP) for hESC/iPSC research, process development and manufacturing.
  • Quality Systems - Our mission is to provide the highest quality products and services to support our customers. We already have QA and QC infrastructure set up to support cGMP product release.

Lonza has the expertise, facilities, and quality systems to support our clients throughout the process.  Our clients include:

  • Pharmaceutical companies looking to implement more biologically relevant cell models into their screening campaigns
  • Translational researchers looking to improve yields and purity of their differentiated cell type of interest for pre-clinical studies
  • Cell therapy clients looking for generation of iPSC banks under cGMP conditions and manufacture of cGMP grade cell products to support their clinical trials

 

 

Figure 1: Lonza services span the full value chain of pluripotent stem cells from tissue acquisition to differentiation.

Specifically, we offer:

  • Tissue Acquisition - We have a dedicated team that procures both research and cGMP grade tissue according to the highest ethical standards and in compliance with government regulations.
  • Reprogramming - We offer cGMP and non-cGMP iPSC generation under feeder- and feeder-free conditions using a zero-footprint technology.
  • Growth / Expansion / Banking - We have established protocols using all of the common medium, matrix, and passaging methods.  We also have the infrastructure and resources to support small- and large-scale culture and banking of PSCs.
  • Characterization - We offer all the standard methods of characterizing PSCs including thawing efficiency, myoplasma and sterility testing, karyotype analysis, short tandem repeat genotyping, pluripotency marker expression (flow cytometry and immunofluorescence), and pluripotency assays (embryoid body and teratoma formation).
  • Differentiation - We have established protocols for the production of PSC-derived motor neurons, dopaminergic neurons, and neural stem cells.  We also have development programs underway to add to our differentiation portfolio of therapeutically relevant cell types.
  • Process development - Over the years we have built up expertise in the differentiation of high purity, functional cell types.  Our team is well versed in technology transfer and optimization of manufacturing protocols.

 

Click here for end user restrictions on induced pluripotent stem cell lines manufactured by Lonza. 

 

European Pharmaceutical Review interviews Minh Hong, Sales Manager from Lonza.    

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