From your first product batches to phase 3 scale-up, we provide the comprehensive fill and finish services you need at every step in the development of your injectable drug candidate.Explore the flexible, high-quality, technically advanced support we provide from our dedicated clinical manufacturing sites in the US and EU.
From supplying your in-human trials, to conducting analytical studies, to securing regulatory approvals, your manufacturing needs grow rapidly on the path from molecule to therapy. At each of those challenging steps, you need a responsive, collaborative CDMO who’s committed to meeting both critical timelines and the highest possible quality standards.
For that, look no further than the skill, experience, and cutting-edge solutions you’ll find at Vetter. We fill a wide range of clinical products in a variety of primary containers, with flexible processes and supporting services that scale with your product’s development.
With Vetter as your partner, our skilled project managers will guide you through key fill and finish processes across your product’s development cycle.
Our clinical manufacturing services include:
We are excited to work with such a high quality and reliable partner. With Vetter’s world-class support, we have further strengthened the supply chain for sonelokimab from drug filling through to finished product.
Oliver Daltrop, Chief Technical Officer, MoonLake
Our collaboration with Vetter remains highly positive. As our clinical filling partner, they deliver high-quality batches crucial for early-phase trials. Their expertise supports the development of Factor H (CPV-104) for C3 glomerulopathy and broader indications. Vetter’s reliability and commitment make them a trusted partner at this critical stage.
Dr. Andreas Schaaf, Managing Director & Chief Scientific Officer, Eleva
We’re actively expanding our clinical manufacturing services through continual investment in expertise, resources, and capacity.
Today, we have dedicated facilities in both the US and EU – both of which produce high-quality clinical trial material (CTM) for development programs around the world. We work closely with each of our customers to select the optimal site and filling line for their strategic requirements and product needs.
Clinical manufacturing and commercial manufacturing are both GMP-compliant processes that serve distinct purposes at different phases of the drug product lifecycle.
Clinical manufacturing focuses on producing smaller, flexible batches of injectable drug candidates to support Phase I through Phase III in-human trials. Agility is often the priority: Accommodating evolving formulations, relatively small unit counts, and the rapid timelines that development-stage programs demand.
Commercial manufacturing is built for scale, consistency, and global supply, with a focus on producing uniform batches that can reliably meet worldwide demand. At the commercial stage, processes are fully validated, and quality systems are calibrated for high-throughput performance.
Engage us as early as possible in your clinical development roadmap. For a sterile injectable project, collaboration with a contract manufacturing partner should ideally begin during pre-clinical development, before finalizing your Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) submissions.
This early engagement gives us the opportunity to define the manufacturing processes, primary packaging choices, and analytical methods you commit to in your regulatory filings, and to verify that they are technically feasible, scalable, and fully validated before beginning the filling process.
The timeline for this partnership can vary based on a number of factors, such as batch size, API availability, container type, and the amount of additional development work needed to comply with GMP. For a Phase I/II sterile injectable (liquid vial), after successful kickoff, a typical project timeline from PDS approval to CTM fill is approximately 6 months.
Our dedicated clinical manufacturing sites in Chicago, USA and Rankweil, Austria are purpose-built to support the transition from lab to in-human evaluation, with specialized teams, equipment, and processes focused on early-phase injectable programs.
At every step of a partnership, our aseptic manufacturing experts guide sponsors through the clinical manufacturing process with the responsiveness and flexibility that early-stage programs require. We provide comprehensive support for new injectable product candidates, reducing the complexity that can come with multi-partner project networks. Our in-house analytical capabilities — including method transfer and stability testing — also help avoid the delays that come with relying on outside labs.
The result: A streamlined path from API handoff, to first GMP batch, to first patient dose.
We are proud to work with a wide range of pharmaceutical and biotech companies that own a diverse spectrum of sterile injectable drug products. Currently, over 80% of our customers’ clinical-stage products are complex biologics, such as monoclonal antibodies, oligonucleotides, and other sensitive, technically demanding substances.
Our partners include organizations of every scale, from global strategic enterprises with diversified portfolios to startups and spinouts going to the clinic for the first time. While some of the world’s largest sterile injectable owners rely on us to support their clinical development programs, 40% of our clinical-stage customers have fewer than 50 employees.
Our clinical and commercial manufacturing services are closely and purposefully integrated to enable successful tech-transfer.
Our clinical sites in Chicago, USA and Rankweil, Austria, were both designed to support efficient transitions to our commercial manufacturing hub in Ravensburg, Germany, including shared technology platforms, quality systems, materials, production resources , and more. Process knowledge, analytical methods, and quality data built during clinical development can be transferred directly into our commercial production environments.
Our process design and tech transfer teams also manage this handoff carefully, overseeing process performance qualification batches and change controls to provide a validated, quality-first pivot from clinical to commercial manufacturing. Regulatory continuity is built in as well: Vetter's CMC specialists support sponsors from clinical development through market authorization and beyond, with an established track record across the FDA, EMA, and other major global authorities.
