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Cell Line Development
cGMP Manufacturing
 
   
  Biomanufacturing
   
 
   
  From Gene to Clinic and Beyond, Gala can support all of your mammalian cell line creation and biomanufacturing 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 100L bioreactors
   
 
   
  There are several advantages to this gene-to-clinic approach to biomanufacturing:
 
  • All operations from cell line development through production of Phase II clinical material are performed in a single facility
  • Seamless technology transfer for production of Phase III and commercial-scale material
  • Both facilities are equipped with similar bioreactor systems and standard operating procedures, leading to increased consistency, stability, and favorable lead times for adaptation and scale-up.
  • Single point of project management across all aspects of gene-to-clinic projects — client only deals with one “contact”.
   
  Catalent Pharma Solutions -- North Raleigh, North Carolina
  In addition to large-scale manufacturing, Catalent Pharma Solutions provides:
 
  • Product development
  • Formulation
  • Assay development
  • Lyophilization
  • Release testing
  • Stability testing
  • mAb conjugation: toxins and radioisotopes
  • Sterile fill-finish
  • Sales/Marketing/Distribution of final product
   
 
   
   
   
 
 
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