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Clinical trial manufacturing

Clinical trial manufacturing

Our clinical manufacturing capabilities in the US and Europe combined with our focus on time-to-clinic can streamline your path to clinical trials. With dedicated project management, we provide the confidence that all the necessary steps for clinical batch release of your compound are completed on time. We provide early-phase clinical trial manufacturing for a broad range of ISO R and US mL vials, prefilled syringes, and cartridges. And our flexible filling lines mean we can provide a range of clinical batch sizes depending on your specific needs and requirements. 

Our clinical manufacturing services for phase I-IlI include: 

  • compounding
  • filtration
  • preparation of primary packaging materials
  • aseptic filling
  • lyophilization
  • terminal sterilization
  • visual inspection
  • stability testing

Clinical trial manufacturing in the US, Chicago

With our clinical manufacturing facility the US we provide dedicated early phase filling capabilities for clinical trial material (CTM): 

  • Vials liquid up to 15,000 batch size
  • Vials lyophilized up to 6,300 batch size (depending on vial size) 
  • Syringes up to 25,000 batch size

Small-scale, clinical vial filling
 

Weighing and measuring a drug's ingredients

Lyophilization of vials

Clinical trial manufacturing in Europe, Germany

Our capabilities include syringes, cartridges and vials in Ravensburg, Germany for clinical trial material in cleanrooms designed and qualified for both clinical supply and commercial manufacturing.

CTM Lyophilization

We offer cGMP clinical lyophilized vial manufacturing at both our Chicago and Ravensburg facilities and dual-chamber system filling at our Ravensburg facility. Our development team not only helps you develop a robust, scalable manufacturing process but also works with you to optimize that cycle according to the characteristics of your product and the primary packaging materials.

 



To get your clinical manufacturing project started, contact us now

Get in touch with us to discuss the specific needs of your valuable compound.


 

Discover more

Clinical trial manufacturing for

Liquid and lyophilized vials

  • Fill volume: 0.1 – 50 ml

Fill volumes beyond will be evaluated upon request.

Single-chamber syringes

with V-OVS® tamper-evident closure:

  • Fill volume 0.1 – 10 ml

with RNS staked needle:

  • Fill volume 0.1 – 1.1 ml
  • Fill volume (pre-sterilized): up to 3 ml

Vetter Lyo-Ject® dual-chamber syringes (lyo/liquid or liquid/liquid)

  • Dosage volume up to 5.6 ml

volumes beyond will be evaluated upon request

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Development Service

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Vetter is a global CMO for aseptic fill & finish contract manufacturing

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