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Vetter Commercial Manufacturing

Vetter Commercial Manufacturing

Commercial manufacturing of pharmaceutical and biotech dosage forms is a complex business today, requiring close integration of sophisticated resources and technologies - as well as a clear understanding of both present and future market needs. Commercial manufacturing is at Vetter’s core, with decades of experience identifying and solving quality and supply chain challenges. Discover how we can deliver results from clinical manufacturing through global market supply.

Service portfolio

Vetter offers a full range of services to deliver quality across the supply chain. Our services include:

Fill and finish

Vetter provides complete fill and finish services for aseptically prefilled drug delivery systems including syringes, cartridges, and vials, and specialized technologies such as dual-chamber systems. Our production facilities utilize industry-leading Restricted Access Barrier (RAB) technology, which ensures the required sterility in filling and finishing. Each of our 3 independent commercial facilities includes its own analytical and microbiological testing resources and 100% visual inspection process, and complies with all cGMP standards and FDA guidelines.

Analytical service

Using sophisticated analytical techniques, Vetter’s highly trained analytical quality control staff provides validation of all raw materials, bulk solutions, in-process materials, and finished product. The analytical team is also regularly involved in highly customized, intensive work to guide the transfer and validation of microbiologic and chemical analytical methods. All utilities, cleanrooms, and processes are routinely monitored according to cGMP and FDA requirements.

Regulatory support

Vetter provides extended regulatory support services to meet your product’s special requirements after drug approval – such as change announcements or preparing of variation documentation. Our regulatory consulting services are also available to support development of annual product reviews in accordance with EMA and FDA requirements.

Product life cycle management

During every stage of development, Vetter works closely with you to develop product life cycle management strategies that expand your product’s potential. These strategies may include support for entering new countries and regions, seeking new indications to increase market share, or reformulating your compound for delivery systems that enhance safety and convenience. Our life cycle strategists strive as well as build and maintain your product’s success over the long-term – as well as meet changing health care requirements and regulatory guidelines.

Compounding

Compounding

Aseptic filling of syringes

Aseptic filling of syringes

Visual Inspection

Visual Inspection

Compound expertise

Vetter offers unparalleled expertise in both small molecules and complex, sensitive compounds such as biologics. Vetter Commercial Manufacturing experts have direct experience in the successful fill and finish manufacturing 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 capacity and systems

Vetter can be your partner in commercial filling and finish, with high-speed, flexible filling lines. We can produce a variety of batch sizes for:

  • Vials (liquid products) up to 150,000 batch sizes
  • Vials (lyophilized products) up to 96,000 batch sizes
  • Single-chamber syringes up to 500,000 batch sizes
  • Dual-chamber syringes up to 50,000 batch sizes
  • Single-chamber cartridges up to 150,000 batch sizes
  • Dual-chamber cartridges up to 60,000 batch sizes

Quality management

Meeting high-quality and safety standards is essential, and quality management expertise is critical. That’s why we have highly dedicated Vetter experts on our Quality Management teams and why we provide Quality Oversight at each facility. Our focus on quality and supply chain metrics helps us monitor quality from the earliest stages of product development to delivery to the market:

  • Integrated TrackWise® IT System to monitor quality and track regulatory data
  • Key Performance Indicator (KPI) reporting, including Right-First-Time (RTF) batch quality and On Time in Full (OTIF) supply performance
  • Permanent Process Optimization (POP) program to increase API yield and reduce batch cycle times
  • Analysis of process steps to determine potential production changes that can improve yields, reduce batch cycle times, and reduce errors

Facilities

Over the past decade, we have made significant strategic investments in our facilities to meet our customers’ needs for quality, capacity, and efficiency. 

3 commercial sites located in Germany

3 commercial sites located in Germany

  • High-speed, flexible, cGMP production lines
  • Independent power supplies
  • 10+ cleanrooms with Restricted Access Barrier Systems (RABS)
  • Material preparation and compounding areas
  • On-site chemical analysis and microbiology labs
  • Disposable equipment and reusable stainless steel
  • Integrated QA/QC system
  • Global regulatory track record
Secondary packaging facility

Secondary packaging facility

  • Fully and semi-automated packaging lines
  • Dedicated packaging line that meets Japan’s ultra-low-particle and no-defects market requirements
  • Strict F-class hygienic conditions for all packing
  • Complies with cGMP guidelines for the USA, Europe, and Japan
  • Global regulatory approvals
Center for Visual Inspection and Logistics

Center for Visual Inspection and Logistics

  • 100% visual inspection process (manual and automated)
  • High-bay, climate-controlled warehouse for cold storage and room-temperature products
  • Global regulatory approvals

Aseptic commercial filling for

Aseptic commercial 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): 0.1 - 20 ml

Vetter Lyo-Ject® dual-chamber syringe (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.

Flyer

Vetter Commercial Manufacturing

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