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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 products) up to 10,000 batch size
  • Vials (lyophilized products) up to 6,000 batch size
  • Syringes up to 30,000 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.

 


Register for our upcoming webinar: "Avoiding Delays to the Clinic"

A checklist to help bring your drug product to the clinic on time

In this webinar we discuss how to prepare for clinical manufacturing by identifying the major reasons why projects get delayed and ways to avoid them. Dr David Brett will provide tactical insights on this issue including, establishing a plan to choose primary packaging and materials, how to prepare legal documents, and guidelines for choosing a development and manufacturing partner that can offer the quality necessary for filing for approval on time.

Date: November 15,  3PM London, Time: 10AM New York / 4PM Berlin



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 Vials

Liquid and lyophilized vials

  • Fill volume: 0.1 – 50 ml

Fill volumes beyond will be evaluated upon request.

Syringes

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

Brochure

Development Service

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

Webinar / Whitepaper