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  Working with Gala
   
   
 

Gala Biotech can provide the Cell Line Development capabilities and the Biopharmaceutical Manufacturing capacity to take your drug candidate from Gene to Clinic and Beyond.

Cell Line Development Initial protein product in four months and Master Cell Bank candidate in less than six months.
Process Development Cell line optimization and gram-scale production and purification from small bioreactors.
cGMP Manufacturing Phase I/Phase II cGMP production of clinical trial material in bioreactors up to 200L.

Gala will design a development program that meets your specific goals. Normally, this begins with a milestone-based feasibility study reflecting your product development plan. The result of this study is typically the production of a stable high-expressing mammalian cell line and gram quantities of protein for your analysis and preclinical needs.

At the conclusion of the feasibility study you can outlicense the cell line for production at the facility of your choice or continue to work with Gala Biotech for manufacture of cGMP product for Phase I/Phase II clinical trials at our Middleton, Wisconsin facility.

   
   
  From Gene to Clinic and Beyond, Gala Biotech can support all of your mammalian cell line creation and biomanufaturing needs:
 
  • cDNA to stable mammalian cell line in less than six months
  • Research-scale protein production in roller bottles and/or small bioreactors for process development
  • Scale-up to Phase I material in small bioreactors
  • cGMP manufacturing of Phase I/Phase II clinical material in bioreactors up to 200L
  • Technology transfer/transition for Phase III and commercial-scale cGMP manufacturing
   
 
   
  Please contact us to discuss how Gala Biotech can meet your cell line development and cGMP manufacturing needs.
   
   
 
 
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