Market trends of Prefilled Syringes

Q&A with Shawn Cain, Senior VP of Development and Manufacturing, and Justin Schroeder, Global VP Technical Services.

Advanced parenteral drug delivery devices are expected to grow considerably through 2030. What do you consider to be the most significant technology advancement in this area?

JS – It is an exciting time in the industry and the focus on making drug delivery more conducive to a patient’s lifecycle and fostering a positive experience is really game changing. Whereas drug delivery, particularly for parenterals and biologics, had been historically provided to patients through clinical administration, recent advancements in feature-rich sterile injectable devices providing safer and more convenient self-injection delivery forms, and events such as the Covid-19 pandemic have fast tracked the healthcare industry’s growing acceptance of patient self-injection, enabling patients to continue treatment outside of hospital settings and within outpatient and home environments. This freedom and improved delivery technology leads to a better and more positive patient experience, engendering better adherence to therapy, and ultimately improved health outcomes. It is a virtuous cycle, as patients are increasingly comfortable self-dosing on these platforms, it opens even more opportunities for new medicines and further improvements of these drug delivery devices.

The growth in medical devices, be it needle safety devices for prefilled syringes or autoinjectors, pens and wearables platforms, has allowed the industry to take a significant step forward for standardization and for improving the patient experience. Likewise, these new pathways allow for administration of the growing number of biologic medicines that can be truly life-changing for patients. PCI continues to invest significantly in this area to facilitate development and commercialization of these breakthrough therapies and their advanced delivery forms, at both large scale as well as equally supporting novel medicines and therapies for rare diseases and modest patient populations.

Focusing on prefilled syringes with integrated safety features and the continued emphasis on reducing needlestick injuries, how do you see industry responding?

JS – With leading companies such as Becton Dickinson, Nemera and others, developing what I would characterize as ‘off the shelf’ platform needle safety devices for prefilled syringes, both the economics and the manufacturing technologies have progressed considerably to make needle safety a standard. We continue to see that where sponsor companies develop advanced delivery forms such as an autoinjector, there is absolutely a consideration for a PFS-NSD as an interim lifecycle solution or as a complementary option to the autoinjector platform to serve all markets and pathways for administration. In addition, where clinical trials had traditionally been executed in vial format and PFS platforms were more of a commercial stage drug delivery solution, we are now seeing more and more sponsor companies integrating PFS-NSD (and AI) into their clinical trials. This can provide multiple benefits including a more patient friendly drug delivery, improved patient retention in trials, shortening duration of the trials, and more impactful study data in the drug delivery platform they intend to commercialize in. These factors are of significant benefit for filing and regulatory approval acceleration. I believe in less than 5 years it will be uncommon to find a PFS that does not offer some type of needle safety mechanism.

Recent product recalls have been attributed to factors such as breakages, leachability, defects in packaging, and contamination, hindering the prefilled syringe market growth. What actions do you see being taken to address these issues?

SC – During the drug development process, it is important for packaging materials to be carefully selected to ensure compatibility with the product and to identify any potential for product contamination that could affect product stability or efficacy. Ensuring a robust and stable prefilled syringe product is determined by the work you can do up front and the outsourcing partners you choose. Identifying and working with an integrated CDMO that has sterile manufacturing and packaging experience with the specific delivery method or presentation can be critical, as that partner can provide valuable advice and guidance in making optimal decisions and identifying developmental steps to ensure success.

Experienced CDMOs will have a wealth of experience, from processing a wide variety of different types and makes of prefilled syringes to seeing how different drug products interact with container closures themselves. Sponsor companies should leverage this collective knowledge and experience and make data-driven decisions from the outset, including data collected from extractable and leachable studies and stability programs.

In parallel, physical testing of the PFS and assembled pen or autoinjector are also very important. Collecting data from shipping and handling studies earlier in the development phase will facilitate making the necessary changes to secondary packaging and avoid situations where assembled delivery devices fail in the field. Robust testing and methodology should be employed in the aspects of device assembly, qualification and validation, as well as ongoing manufacturing and supply. These are areas where PCI works very closely with clients to develop a detailed plan for success.

In addition, looking to the manufacturing and sterile filling of PFSs, utilizing the latest advancements in fully automated robotic gloveless technologies will provide increased product sterility and quality assurance. With a robot performing the processes in a recipe driven, validated system and utilizing single-use parts, pre-sterilized flow paths and RTU containers, multiple sources of risk are eliminated including cross-contamination, human error, electro-mechanical filling and closure activity failures, environmental control failures, cleaning and set-up errors; and product loss.

Briefly describe your product or service in the injectables / parenteral market and the need your product is addressing.

SC – PCI is a leading global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions to increase product speed to market and opportunities for commercial success.

Our clients have the aim of accelerating their sterile drug development lifecycle and seek readily available capacity, reducing time to clinic and ultimately commercial launch. They seek experienced partners and PCI plays a key role in navigating development complexities and overcoming manufacturing and packaging challenges posed by both drug products and drug delivery devices.

PCI offers a full suite of sterile injectable drug development and manufacturing services including formulation development, aseptic fill-finish of vials, bottles and prefilled syringes and lyophilization, complete with dedicated in-house QC analytical and microbiological support. Complementing our core sterile manufacturing and filling solutions, PCI offers expert assembly, packaging and labeling of advanced injectables such as prefilled syringes, syringes with needle safety devices, autoinjectors, pens and other drug delivery devices.

Providing integrated end-to-end solutions and helping to reduce supply chain complexity and risk, our clients can leverage the benefits of with working with a single supplier. Combining our expertise in sterile fill-finish manufacturing with specialist biologic packaging, labeling and cold chain distribution provides a valuable end-to-end solution, simplifying the supply chain while delivering time and cost efficiencies.

Please provide an example of how your service/product helped a pharma client achieve a successful prefilled syringe/parenteral program.

SC – Our European sterile fill-finish facility in León, Spain entered into an agreement with a mid-sized biopharmaceutical company who was looking for a technology transfer of their oncology prefilled syringe product. The project began with the program in early development, it was a complex subcutaneous injection in suspension product with a challenging step of sieving during suspension compounding. The challenge was that this sieving step was to be performed under aseptic conditions, as the product suspension could not be terminally sterile filtered. At the point of project initiation our client had only performed this process under non-aseptic conditions.

Utilizing our wealth of experience, our expert process engineers worked not only to scale up the batch, but also optimized the process of sieving by redesigning the formulation process. This was accomplished by modifications to the equipment and processing components to execute this sieving process in both a GMP and aseptic manner. Initially, the sieving process did not work at the commercial scale, so PCI initiated a Design of Experiments (DOE) program to explore other alternatives to the sieving step without impacting the CQAs or CPPs of the drug product. After multiple DOEs and stability studies, we successfully developed a more robust scalable process with positive stability results and sterility assurance. This project has now progressed to registration batches pending FDA regulatory review for US market supply.

Discussing the market trends of Prefilled Syringes: Q&A with Shawn Cain, Senior VP of Development and Manufacturing, and Justin Schroeder, Global VP of Technical Services. | As seen in Drug Development and Delivery | May 2023.


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