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Clinical syringe development

Clinical syringe development: An early advantage

For many drugs, prefilled syringes seem to be the way of the future. Even though the most common injectable delivery system is still a vial, the market for prefilled syringes is expected to continue its rapid growth over the next several years.

Market, patient, and technological factors are all behind this growing trend. Increasing competition and shrinking pipelines have many drug companies looking to stand out in their markets. Growing regulatory pressures are demanding greater safety and quality. And trends toward self-administration require delivery systems that are easy and convenient to use.

Advantages during both clinical development and commercial production

In the short-term clinical phases, prefilled syringes help increase a drug’s trial appeal with a user-friendly delivery system. Their precise, single-dose format reduces waste of valuable API and helps to enable patient and clinician safety.

During commercial production, a prefilled syringe meets the precise dosing requirements of today’s more complex compounds. It’s efficient for long-term production, saving valuable API due to the reduced need for overfill compared to vials. In addition, the user-friendly nature of prefilled syringes contributes to patient compliance and consistency.

Even as the trend shifts toward prefilled delivery systems, traditional development is still performed in a vial, which is understandable for a number of reasons. Vial development is familiar, well understood, and simpler up front. It makes sense for basic early development work, such as dose-ranging studies. It is less expensive in the early phases, when the risk of trial failure is the highest. And it may be the fastest way to get a new drug substance to market, an important factor if that drug is filling a critical unmet therapeutic need.

However, if the drug company envisions the end product in a prefilled syringe, it makes sense to include syringe development earlier in the process, rather than just prior to launch. This innovative approach can offer 2 main advantages:

  • Earlier development in a syringe can shorten the timeline of a sequential transition from vial to syringe – resulting in a potential launch time savings of up to 18 months
  • A differentiated drug product, keeping the company in step with a changing market and creating competitive advantages in similar therapeutic spaces

Vetter makes syringe development easier

As an industry-leading CDMO in this field, we have the experience, knowledge, and technology to support you accelerating and facilitating your drug development process in a syringe.

  • Extensive experience with complex compounds including monoclonal antibodies, peptides, interferons, and vaccines
  • Scientists who know how to work with early-stage compounds and the challenges they present. We partner with customers to design a robust development process that both meets a compound’s specific requirements and already mirrors commercial production, for a smooth scale-up to Phase III and subsequent large-scale production
  • cGMP clinical syringe filling lines with state-of-the-art technology at our US and European facilities
  • A Chicago facility entirely dedicated to clinical manufacturing and offering automatic syringe filling

Vetter’s modular, customized clinical syringe packages give you the options you need to stay flexible. The Clinical Syringe Standard Package includes all development services needed to efficiently develop your prefilled syringe product for launch, either in a syringe only, or for a co-launch with a vial-based product. The portfolio includes services such as package material consultancy, analytics and regulatory consultancy, and laboratory services as well as tech run, formal stability fill, and clinical filling. The Clinical Syringe Starter Package offers development services designed to provide feasibility data for possible full development at a later date – allowing you to get a valuable head start without committing to a clinical fill. This portfolio includes package material consultancy, analytics and regulatory consultancy, feasibility testing in syringes options, and a non-GMP run for stability data.

Vetter is ready to work with you no matter the path you take. With more than 35 years of experience, we have the knowledge and expertise to support you from initial development through clinical trials and on to commercial production.