Advanced Drug Product Services Address Today’s Growing Prefilled Syringes Market

The growing demand for advanced parenteral drug delivery devices, such as prefilled syringes (PFSs) and autoinjectors, can be attributed to several factors, including the rising prevalence of chronic diseases, increasing patient preferences for convenient administration, and continuing technological advancements.

The PFS is typically used to package biologics and vaccines and has emerged as a key device and reliable method for delivering a pre-measured, single dose of a parenteral product.

Ready-to-use syringes offer several advantages, such as higher yields, accurate dosage administration, and enhanced patient safety. They also support formulation stability and improve shelf life. However, manufacturing these devices has challenges, as PFS production requires highly specialized equipment and facilities that must comply with stringent regulatory standards.

David King, Senior Director of Drug Product Compliance at Samsung Biologics, shares his perspectives on the growth of the PFS market, today’s drug product trends, and the necessary technologies for optimal delivery.

Contract Pharma: We see continued rapid growth in the PFS space; what are some of the evolving needs of pharma/biopharma companies?

David King: I can think of two main reasons behind the continued growth of the PFS market. 

First, prefilled syringes offer higher yields. Since the syringes are ready to use, they eliminate the transfer step from vial to syringe, reducing product loss during administration. This efficiency allows for more syringes to be manufactured from the same batch, leading to increased availability for patients and greater profitability for manufacturers. 

Second, they provide significant convenience for healthcare professionals and patients. Since the medicine is already pre-measured and pre-packaged in the syringe, there is no need to handle or prepare the dose, which saves time and minimizes the risk of dosing errors. This is especially valuable as more therapies are self-administered by patients, particularly in cases that require frequent or long-term medication.

Contract Pharma: What types of drug products are most prevalent today, and which technologies are needed to support them?

David King: Biologic products or biopharmaceuticals are preferred in most cases, as they are usually targeted. A great example of targeted therapies is the emerging market of antibody-drug conjugates (ADCs). ADCs are commonly developed using monoclonal antibodies (mAbs), which target specific cells within the body, such as cancer cells. These ADCs include a linker that connects the mAb to a toxic payload. The mAb attaches to the cancer cell and delivers the toxin. This is an example of the types of products prevalent today, where molecules are complex and highly specific to patient tissue. These products tend to be less stable and require stabilizing formulations or additional shelf life support, such as oxygen-deprived spaces and freeze-drying.

Contract Pharma: What are the key challenges with the development and manufacture of PFSs in today’s market, and how can they be addressed?

David King: PFS manufacturing requires specialized equipment and facilities that are tightly governed by regulatory bodies, such as the FDA and EMA. In the past, PFSs primarily focused on vaccines, where large-scale manufacturing was used to offset costs. Today’s challenges have changed as we start to find more specialized medicines that are costly and produced in smaller batches. This change has increased risk and reduced the capacity of the equipment to produce high annual volumes.

Contract manufacturing and development organizations (CDMOs) are highly focused on quality risk assessments, where the client and CDMO can fully understand the manufacturing process risks associated with the intended product. Risk management tools help to identify high- and critical-risk areas and, most importantly, provide the early awareness needed to reduce these risks to acceptable levels. So, if CDMOs want to maximize annual capacity and yields for their clients, they will most often adopt a single-use system (SUS) for product transfers. An SUS can reduce manufacturing time during critical product changeover (PCO) events, and it can be customized to the product specifics to reduce the volume of routine batch-to-batch losses, such as filter flushes and air bubble removals.

Contract Pharma: Which technologies and capabilities are needed to streamline fill–finish processes?

David King: The industry is responding to changing demand, and AI, isolators, and unique filling equipment technologies are expected to reduce costs and risks. AI systems are being used to reduce staffing requirements, providing a twofold benefit. First, AI-powered automation reduces the risk of human error and ultimately provides a more consistent manufacturing process. Second, reduced human contact decreases the risk of product contamination.

The use of isolator systems has gained strong support from regulatory bodies, particularly the EMA, following the recent Annex 1 revisions. PFS-filling equipment vendors have recently started offering automatic refilling when a syringe is underfilled and re-stoppering when a position error is detected. Both of these technology options for the filling equipment can increase yields with little risk. Beyond AI, isolators, and unique filling equipment technologies, time to market remains a priority for most biopharmaceutical companies. Equipment manufacturers can reduce PCO times by using quick-changeover systems or versatile parts that can accommodate many primary component sizes.

Contract Pharma: With diverse market demands, what capabilities are needed to accommodate both large- and small-scale manufacturing?

David King: If the product is to be produced in large batches, such as 200,000+ syringes over multiple days, the best solution is to use a hard-pipe, typically stainless steel, fluid path from the tank to the needles. These hard-pipe systems can withstand large batch sizes and have a long history of success. In small-scale PFS manufacturing, the best choice is to use an SUS, as the filling accuracy is acceptable and PCO times are greatly reduced. Also, with an SUS, the need for cleaning validation is greatly reduced because the SUS fluid path is discarded and not reused.

Contract Pharma: Are there any specific areas Samsung Biologics is investing in to meet biomanufacturing needs?

David King: Samsung Biologics has expanded its capabilities into the PFS market. This decision was made to meet the needs of current clients and recognizes that the PFS market is in a state of high demand, which is predicted to persist.

In addition to PFS services, Samsung Biologics has started offering end-to-end ADC development and manufacturing. This is a capability that only few CDMOs can offer, but as Samsung Biologics is a leader in mAb production and has a strong history in drug product manufacturing, it makes sense. ADC manufacturing at Samsung Biologics begins at the development stage within the CDO department and then advances to small- and/or large-scale production. Commercial-scale mAb production is completed in BioCampus 1 or 2. The product is then transferred to the independent ADC facility. In the ADC facility, the linker is attached to the mAb, and the payload is attached to the linker. The ADC product is filled into vials, freeze-dried, visually inspected, labeled, and fully packaged in the Drug Product department in the ADC facility.