Vetter Development Service helps smooth the path to clinic for new molecules at the preclinical stage through to phase III, with dedicated support for key stages of development, testing, clinical manufacturing and regulatory approval. Here, the company considers the benefits of integrated, thoughtful, efficient life-cycle solutions for long-term growth and success.

Vetter’s Chicago facility provides clinical manufacturing from preclinical development through phase II, with scale-up and transfer to commercial manufacturing facilities. The Chicago site is designed specifically for supporting your early-stage, high-value biopharmaceuticals.

Vetter Development Service Chicago fills clinical trial materials under strict aseptic and GMP standards. Thanks to state-of-the-art technology and innovative processes, the company will help increase your API yield. Vetter Chicago offers:

  • 30,000ft2 of clinical manufacturing excellence state-of-the-art clinical manufacturing cleanrooms flexible cGMP filling for all common drug delivery systems
  • release testing according to European and US cGMP regulations onsite microbiology and chemical analysis lab use of disposables in manufacturing customer method transfer.

Benefits of Vetter Chicago’s services include:

  • fast and flexible operations
  • high process integrity through RABS
  • wide batch-size offering, ranging 500-25,000 units
  • customer use of clinical trial material in Europe and the US without retesting
  • no need to change suppliers due to seamless transfer to phase III and commercial manufacturing.

In addition to its Chicago offering, Vetter provides a global end-to-end development service, as outlined below.

Formulation support
In early clinical development, preformulated compounds may sometimes require a high level of support prior to process development. Vetter Development Service can work with your team to optimise preformulated active pharmaceutical ingredients (APIs) for clinical trial. The company can also identify the strongest of several prequalified candidate drug formulations through compounding and filtration studies, material compatibility analysis, and lyophilisation cycle testing. Transfer, optimisation of analytical methods, and validation is also provided.

Process development
The goal of process development is fast, smooth transfer of a project to commercial manufacturing. Tailored to a product’s specific requirements, services include: siliconisation methods studies for the appropriate drug delivery system, filter compatibility testing, lyophilisation cycle development (as required), feasibility studies; engineering batches; stability batches, validation batches, method transfer and scale-up for commercial manufacturing.

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 lyophilisation, terminal sterilisation and visual inspection. Precise indicators are also generated for the master batch record.

Analytical service
Validation of raw materials, bulk solutions, materials and finished products is determined by sophisticated analytical techniques. Vetter’s highly trained quality control staff provide expert support for the critical transfer of analytical methods. All instruments and methods are aligned with international requirements.

Regulatory support
Vetter supports you through all phases of regulatory submission. Expert technical writing and dossier preparation begins in parallel with clinical production to streamline the regulatory submission process, supported by the company’s in-depth knowledge of global regulatory requirements, including FDA, EMA, PMDA (Japan) and RP (Germany).