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. 

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 

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.  

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