CLINICAL AND COMMERCIAL DRUG SUBSTANCE MANUFACTURING

Drug substance manufacturing services to support your product's growth.

With integrated multi-product facilities all within North America, we are positioned to manage your program's unique needs from development to scale-up from early phase to commercial tech transfer. 
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BEST-IN-CLASS CAPABILITIES:

Certified multi-product facilities all located within North America
  • Certified multi-product facilities all located within North America 
  • Strong network of facilities, equipment, materials, digital solutions, and operational excellence to fit your program’s specific needs 
  • Early phase to commercial tech transfer expertise with established stage-gate approach 
  • Extensive experience and expertise in viral vectors, vaccines, mAbs, enzymes, fusion proteins and bispecifics
  • Cell bank GMP Production (MCB and WCB) 
  • BSL1 and BSL2 capable manufacturing suites 
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Kickstart Your Next Step

Since better information helps drive better decision making, we’re making it easy to get the data points you need to map a straight path ahead. Spend a few moments completing a quick assessment, and, based on your answers, we’ll automatically open up resources – some available here exclusively – that are aligned with the most pressing needs you’ve identified.  

TAKE ASSESSMENT NOW

 

ADVANCE WITH CONFIDENCE

  • Process optimization and scale-up for reduced COGs  
  • Optimization of clinical programs for robust and reliable commercial supply of bulk drug substances 
  • Accelerated Process and analytical development for speed to early clinical introduction 
  • Process characterization and validation to support late-stage clinical and commercial manufacturing  
  • Wide range of experience, including: mAbs, fusion proteins, enzymes, bi-specifics, complex recombinant proteins, conjugated proteins, and microbial proteins 
  • Integrated formulation and fill/finish 
SPEAK WITH AN EXPERT

Let’s Start a Conversation

You’ve no doubt filled out a million forms before. But this is the first one to us – and we’re excited to hear from you. Let’s see if your biomanufacturing needs and our capabilities are a good match.