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Vetter Development Service

Vetter Development Service

The period from preclinical through Phase III is sometimes unpredictable for new molecules. With Vetter you have a development partner you can trust to support you throughout drug product development, clinical manufacturing, and regulatory approval. Take advantage of our expertise, our ongoing technological investment, and the experience counted on by top biopharmaceutical companies. 

Chemical analysis

Compounding

Automated vial filling

Drug development service portfolio

Vetter offers a full range of development services to help streamline your molecule’s path through clinical development and on to market:

Formulation support

Vetter can work with your development team to optimize preformulated API for clinical trial – and identify the strongest of prequalified candidate drug formulations through compounding and filtration studies, API/material compatibility analysis, and lyo cycle testing.

Process development

To enable fast, smooth transfer to commercial manufacturing our process development service inlcudes: siliconization methods studies; filter compatibility testing; lyophilization cycle development; feasibility studies; engineering, stability and clinical batches; and method transfer, scale-up for commercial, as well as validation batches.

Clinical trial manufacturing

Following confirmation of successful scale-up, clinical trial manufacturing begins. Key steps include compounding, filtration, preparation of primary packaging materials, and filling. Additional steps may include lyophilization, terminal sterilization, and visual inspection. Precise indicators are also generated for the master batch record.

Analytical service

Validation of all raw materials, bulk solutions, in-process materials, and finished product is determined by sophisticated analytical techniques. Our highly trained analytical quality control staff also provides support for the critical transfer of analytical methods.

Regulatory support

We support you through all regulatory phases for new market entrants and products already on the market. Our in-depth knowledge of global regulatory requirements  (FDA, EMA, and PMDA) will help you with regulatory documents that are related to Vetter’s processes and needed for clinical studies, as well as marketing authorizations for registration. 

Fully-automated aseptic vial filling

Fully-automated aseptic syringe filling

Lyophilization of vials

Compound development expertise

Vetter offers extensive expertise in both small molecules and complex, sensitive compounds such as biologics. Our development experts have direct experience in the successful fill and finish process development of many classes of compounds, including monoclonal antibodies, peptide hormones, fusion proteins, low-molecular-weight heparins, interferons, oligonucleotides, erythropoietins, vaccines (non-live), enzymes, human growth hormones, interleukins, and coagulation factors. We are also experts in a broad range of product forms such as microparticles/suspensions, diluents, lyophilized compounds, and ophthalmics.

Clinical filling volumes

Vetter can cover a wide range of capacity needs, from preclinical through full clinical supply. We offer the following services at our dedicated clinical filling facility in Chicago, Illinois, USA:

  • Preclinical and Phase I: ~300 to 1,000 fills
  • Phase II: 1,000 to 10,000 fills
  • Phase III and beyond

Greater fill volumes are at our facilities in Ravensburg, Germany.

Clinical manufacturing facilities in the US and Europe

Vetter operates a dedicated clinical facility in Chicago, Illinois, USA, and combined clinical and commercial facilities in Ravensburg, Germany.

Clinical manufacturing facility in Chicago

  • 30,000 sq ft of laboratory space, including cleanrooms
  • 2 cGMP Grade A, Class 100 cleanrooms
  • On-site chemical analysis and microbiology labs
  • Dedicated to Phase I and Phase II
  • Uses disposable technology to preserve API and shorten timelines

Clinical manufacturing facility in Ravensburg

Clinical manufacturing facility in Ravensburg

  • 4,520 sq ft of laboratory space plus additional cleanrooms
  • 10+ cGMP Grade A, Class 100 cleanrooms
  • On-site chemical analysis and microbiology labs
  • Phase I to Phase III
  • Clever use of disposable (single-use) and dedicated technology

Clinical trial material

Clinical trial material Vials

Liquid and lyophilized vials

  • Fill volume: 0.1 – 50 ml

Fill volumes beyond will be evaluated upon request.

Syringes Syringes

Single-chamber syringes with V-OVS® tamper-evident closure system

  • Fill volume 0.1 – 10 ml

Single-chamber syringes with Vetter-Ject® closure system

  • Fill volumes will be evaluated upon request

Single-chamber syringes 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 (lyophilized/liquid or liquid/liquid)

  • Dosage volume up to 5.6 ml

Fill volumes beyond will be evaluated upon request.

Cartridges Cartridges

Single-chamber cartridges

  • Fill volume 0.1 – 5 ml

V-LK® dual-chamber cartridges (lyophilized/liquid or liquid/liquid)

  • Dosage volume: up to 1.1 ml

Fill volumes beyond will be evaluated upon request.

Brochure

Vetter Development Service

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