Within the past few decades, there has been a steady increase in the use of pre-filled syringes (PFS) for parenteral administration of biologics, biosimilars, and other drugs. A recent report predicts that the global market for pre-filled syringes will grow from $7.91 billion in 2023 to $16.32 billion by 2030, largely driven by the wealth of advantages that pre-filled syringes can provide1. These include the reduced risk of contamination, improved dosing accuracy, and greater convenience and ease of use for patients and healthcare professionals. Market growth within the PFS sector can also be attributed to the ever-expanding range of aseptic fill finish services being offered by contract manufacturing organizations (CMOs).
When choosing a CMO partner for PFS manufacturing, there are numerous factors to consider. Paramount among these are whether the CMO has a patient-first culture, an emphasis on operational excellence, and a commitment to meeting customer mandates for quality, reliability, and assurance of supply. In addition, selecting a CMO with a unified quality system is key to ensuring site-to-site consistency, while identifying a partner with a “right first time” continuous improvement culture helps guard against potentially catastrophic aseptic fill contaminations and batch failures. Other critical considerations should center on the CMO’s global capabilities, locations, and supply chain, its regulatory record, and whether it is open to building strategic relationships that leverage its facilities, expertise, and capacity for manufacturing at scale.
AbbVie CMO has been supplying medicines worldwide to third-party customers since 1985, including over a decade spent producing blockbuster biologics for global distribution. Because we are more than just a CMO, we have the unique advantage of leveraging extensive know-how and capabilities from a leading pharmaceutical organization, which includes its global quality and regulatory systems. Not only does this ensure that our customers receive unparalleled support throughout the entire drug development and manufacturing continuum, but it also allows us to adopt a more careful and conservative approach to project planning, resulting in the available capacity as promised to meet your demand. Through ongoing investment in our people, processes, and facilities, we offer a compelling option as your partner of choice, whatever your aseptic fill and finish requirements may be (vials or PFS).
Expertly engineered multi-product facilities approved for PFS manufacturing
Multi-product facilities are integral to PFS manufacturing. However, to function effectively, they must be designed to accommodate the complex networks and supply chains involved in drug production and be readily adaptable to the intrinsic variability between different technologies, processes, and logistics requirements. Such facilities should also be built to cope with ever-changing quality and regulatory requirements. See how AbbVie has prepared our global sites to meet updated Annex 1 requirements.
AbbVie’s Puerto Rico biologics manufacturing facility has been supplying medicines worldwide for 16 years. Designed and approved for bulk drug substance (mammalian) and pre-filled syringe manufacturing, it boasts a 38,180m2 footprint that incorporates a full QC laboratory, as well as logistics and warehousing. Other key attributes include two cell culture suites ranging from 6,000-12,000 L configurations, downstream purification with wholly supported QC/QA, and an aseptic PFS line with 10-channel peristaltic filling supported by automated visual inspection to protect against human error.
A highly trained workforce experienced in PFS manufacturing
A highly trained workforce, experienced in PFS, is fundamental to the success of any PFS manufacturing project. However, when selecting a CMO partner, one should never overlook the importance of workforce stability. A CMO staffed by personnel who have been with the company long-term not only offers the intrinsic benefits of established expertise, but also mitigates against the risk of costly delays should a sudden change in demand necessitate recruiting and training new people.
Many of the 600-plus team at our Puerto Rico biologics manufacturing facility have worked on commercial biologics for over a decade, giving them the knowledge and experience required to proactively plan for supply from any phase to commercialization. And, because many of our personnel have held active roles in developing and manufacturing AbbVie’s own drug products, we have the vision to anticipate challenges and manage most any situation from technology transfer to ongoing supply.
Robust global systems for quality and regulatory
Robust global systems for quality and regulatory should form the core of any pharmaceutical manufacturing process, serving to ensure that the drugs being produced are both safe and efficacious. Specifically, a well-designed quality system will be standardized across sites, updated regularly, and geared toward facilitating continuous improvement, as well as incorporate the regulatory standards from all relevant global markets.
AbbVie has a unified quality system spanning all its global facilities, including seven for biologics and aseptic fill and finish, and many of which function as centers of excellence to safeguard global standardization. Our robust internal audit program and successful regulatory history assure our customers that the products and services they receive will meet their precise requirements, while our holistic quality culture guarantees that patient safety remains our primary goal in everything that we do.
A proven track record in PFS manufacturing
With aseptic fill finish manufacturing being one of the final steps between biopharmaceutical development and patient care, it is essential that everything goes according to plan. A CMO with proven experience in PFS will not only have designed its fill finish operations to run efficiently with minimal loss of product, but will also maintain the lowest possible risk while remaining capable of manufacturing a broad range of drugs at a scale to meet patient demand.
AbbVie has been supplying biopharmaceuticals worldwide since 2003, and has an extensive quality network that is actively managing to all global regulatory requirements including recent Annex 1 updates that went into effect August 2023. Our global pharmaceutical infrastructure and experience delivering products to patients in over 150+ countries provide operational, quality, and regulatory expertise necessary to give our partners piece of mind as they head toward commercial launch.
Unrivalled precision planning and forecasting capabilities
A robust planning process, including the ability to plan for upside potential or unforeseen events, represents a major difference between a CMO that performs PFS manufacturing accurately, conservatively, and on schedule, and a CMO that overcommits and underdelivers. Selecting a CMO with expert precision planning and forecasting capabilities is crucial for assurance of supply, irrespective of whether demand should suddenly increase, or a vital raw material should unexpectedly become unavailable.
At AbbVie CMO, we pride ourselves on our planning process, which we undertake on both an annual and a long-range basis. AbbVie has developed and launched some of the world’s largest biopharmaceuticals. By understanding all potential risk factors associated with each PFS manufacturing project, and second sourcing every raw material, we are able to implement contingency planning that anticipates and manages with precision any challenges for assurance of supply, commercial launch, or changes in demand to ensure that nothing is left to chance.
Your preferred partner for PFS manufacturing
Selecting the right CMO for PFS manufacturing is critical to the success of your project. A preferred partner should demonstrate a patient-first culture, an emphasis on operational excellence, and a commitment to meeting customers’ mandates for quality, reliability, and assurance of supply. In addition, expertly engineered multi-product facilities, staffed by a stable, experienced workforce and governed by global systems for quality and regulatory are key to delivering safe, efficacious drugs in a timely manner.
Because AbbVie CMO is part of a global pharmaceutical leader, we share the patient-centric heritage of our parent organization and can leverage its capabilities and know-how to benefit our partner projects and their milestones. The value of this approach is demonstrated by our long track record of supplying medicines worldwide, including over a decade spent producing blockbuster biologics for global distribution. Our PFS manufacturing expertise is unmatched and we are committed to meeting our promises and forecasted capacity demands. With the global market for pre-filled syringes continuing to grow, let us help you realize the objectives of your PFS manufacturing project.
In addition to PFS, AbbVie supports third-party development and manufacturing of biologics bulk drug substance and aseptic liquid and lyo vials. To discuss how AbbVie CMO can support your PFS or other manufacturing project, contact us at www.abbviecontractmfg.com