Clinical Manufacturing US

Your development partner for clinical stages

Specialised CDMO for clinical manufacturing

Choosing the right CDMO partner is the key to successful drug development in early phases. Vetter's clinical production team and state-of-the-art aseptic clinical facility in Chicago provides you with the right balance of quality, schedule and yield maximization for your valuable drug substance.  

Our expertise includes filling vials (both liquid & lyophilized) and syringes.  Decisions made in early clinical phases will impact the success of your product for many years.  Vetter will support your project throughout product development, clinical manufacturing and transfer into one of Vetter’s commercial facilities.  That expertise comes not only from our development experience, but also from more than 35 years of experience at our commercial facilities in Germany.

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John Moore, Director Global Clinical Business Development at Vetter

 

Vetter’s expertise and uncompromising quality has contributed to our success even under our highly aggressive timelines. It has been a pleasure working with the Vetter Teams in Chicago and Germany.

Ron Tetreault, Director CMC, Agenus Inc.

 

Running some numbers

160+

compounds have been filled, many of which have been filled multiple times.

80+

customers with headquarters in 16 different countries.

~60%

of our customers have less than 200 employees.

We can help you with

  • Process design
  • Formulation support
  • Feasibility and stability studies
  • Technical & engineering batches
  • GMP clinical batches
  • Scale-up for late phase & commercial manufacturing 
  • Regulatory support

Download our checklist and brochure for more information:

Clinical filling project scope: major milestones

Step 1: Project kick-off: open communication and exchange of necessary information

Step 2: Customized process development including material requirements and selection of primary packaging material

Step 3: Method transfers, lab qualification and technical runs

Step 4: GMP clinical batch manufacturing

Step 5: Regulatory filing support and clinical batch release

Get in touch

Contact Paulina Broda at infoUS@vetter-pharma.com or +1 (847) 581 6888 to discuss your next project or request more information.

Get in touch