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
- 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.
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.