SFF

Pre-filled syringes (PFS) offer a compelling alternative to traditional vials for injectable biologics. They reflect a focus on patient-centricity in drug delivery. The increasing adoption of PFS within the biologics sector is reflected in the substantial growth of the global PFS market [1]. By offering several key advantages over traditional vials, PFS are transforming how some medications, particularly biologics, are administered and experienced by patients. These benefits include: 

  • Reduced risk of medication errors and contamination
    The design of PFS, being ready to use and pre-filled with the correct dose, reduces the risk of dosing errors and contamination compared with traditional vials.

  • Improved safety and convenience for patients
    PFS align with the increasing demand for convenient and accessible healthcare solutions. They enable some biologics to be administered at home, promoting independence and improving adherence, especially for those managing chronic conditions.

  • Economic benefits due to reduced waste
    The single-dose nature of PFS improves dosing accuracy and reduces waste from leftover medication, which translates to economic and environmental benefits. This is particularly significant for high-value biologics.


How can experienced CDMOs aid PFS development?

For PFS developers, partnering with contract development and manufacturing organisations (CDMOs) with experience and expertise in these drug delivery systems can be a substantial strategic advantage. CDMOs’ knowledge and resources are invaluable in navigating the complexities of PFS development, which involves both technical and regulatory hurdles. Here are some of the technical challenges that an experienced CDMO can help organisations overcome:

  • Formulation development
    A CDMO with experience in PFS can offer support in addressing the complexities of formulation development for this delivery route, considering factors like viscosity, stability and compatibility with syringe materials. They can optimise formulations to minimise aggregation, precipitation and other issues that can compromise drug efficacy and safety.

  • Device integration
    PFS development requires seamless integration of the drug product with the syringe device. A CDMO specialising in PFS has experience selecting appropriate syringe components, such as needles, plungers and seals, and ensuring their compatibility with the drug formulation. They can also assist in the design and optimisation of fill-finish processes to ensure accurate dosing and minimise product loss.

  • Sterile fill & finish
    Aseptic processing and sterile fill & finish are critical for PFS manufacturing. CDMOs with expertise in PFS have state-of-the-art facilities and knowledge of aseptic techniques, ensuring the sterility and quality of the final product. They use advanced technologies, such as isolators and robotic filling systems, to minimise contamination risk.

  • Regulatory compliance
    PFS development is subject to stringent regulatory requirements. CDMOs with PFS experience have in-depth knowledge of global regulations and can ensure compliance throughout the development and manufacturing process. They can assist with regulatory submissions, including documentation and data generation, to support product approval.

  • Advanced manufacturing facilities and analytical capabilities
    CDMOs with specific PFS expertise invest in manufacturing facilities equipped with advanced technologies for aseptic processing, fill-finish and packaging. They have access to advanced analytical instrumentation and knowledge to support formulation development, stability testing and quality control.
     

The strategic advantage of partnering with an experienced CDMO

The future of biologics is inextricably linked to advancements in drug delivery, and PFS are set to play a pivotal role in this evolution. As the demand for self-administration and patient-centric solutions continues to rise, PFS will become increasingly crucial for the successful delivery of these complex therapies. To navigate the technical and regulatory challenges inherent in this process, partnering with an experienced CDMO is invaluable.

Organisations such as Recipharm offer the specialised expertise, state-of-the-art facilities and comprehensive support necessary to successfully develop and manufacture PFS-based biologic therapies. By embracing collaboration and innovation, organisations can work together to shape a future where biologics are delivered with greater precision, safety and patient satisfaction.


References

1. https://www.fortunebusinessinsights.com/industry-reports/prefilled-syringes-market-101946