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Vetter Development Service

Vetter Development Service

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

Service portfolio

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

Formulation support

In early clinical development, preformulated compounds may sometimes require a higher level of support prior to process development. Vetter can work side by side with your development team to optimize preformulated API for clinical trial – as well as identify the strongest of several prequalified candidate drug formulations through compounding and filtration studies, API/material compatibility analysis, and lyophilization cycle testing.

Process development

The goal of process development is to enable fast, smooth transfer of your project to commercial manufacturing. Tailored to your product’s specific requirements, process development services include: siliconization methods studies for the appropriate drug delivery system; filter compatibility testing; lyophilization cycle development; feasibility studies; engineering batches; stability and clinical batches; method transfer and clinical batches; and method transfer and scale-up for commercial, as well as validation batches.

Clinical trial manufacturing

Following confirmation of successful scale-up, clinical production 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. Vetter’s highly trained analytical quality control staff also provides expert support for the critical transfer of analytical methods. All instruments and methods are aligned with current international requirements.

Regulatory support

Vetter supports you through all phases of regulatory submission for both new market entrants and products already on the market. Our in-depth knowledge of global regulatory requirements, especially those of the FDA, EMA, and PDMA (Japan), will help you in the preparation of regulatory documents that are related to Vetter’s processes and needed for clinical studies, as well as marketing authorizations for registration in numerous countries. We also undergo (and pass) regulatory inspections, as well as help our clients secure approval in the global market.

Chemical analysis


Automated vial filling

Compound expertise

Vetter offers unparalleled expertise in both small molecules and complex, sensitive compounds such as biologics. Vetter Development Service 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 (nonlive), enzymes, human growth hormones, interleukins, and coagulation factors. We also are experts in a broad range of product forms such as microparticles/suspensions, diluents, lyophilized compounds, and ophthalmics.

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 filing 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.


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

Vetter Development Service 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

Vetter Development Service Ravensburg

Vetter Development Service 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 that best serves the customer’s requirements

Aseptic clinical filling for

Aseptic clinical filling for 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.


Vetter Development Service

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