Text of Prefilled Syringes - A Container of Choice for Pharma
1. Special Feature prefilled Syringes a container of choice for pharmaBy: Cindy H. Dubin, Contributor T he total syringe market (disposable and reusable) could reach $11.8 billion by 2017, with much of that being stimulated by the prefilled syringe sector (a group that includes prefilled pen injectors, auto-injectors, and needle-free injection devices). According to Global Industry Analysts Inc., prefilled syringes are finding increased use due to their ability to eliminate risk of cross-contamination, and other risks, such as that of drug counterfeiting and dosing error, that may occur with ampoules or vials. A report by London-based business information company Visiongain, Pre-Filled Syringes: World Market Outlook 2011-2021, predicts world prefilled syringe technology revenues will reach $3.9 billion in 2015, up from $2.7 billion in 2010. Expansion of the prefilled syringe market will be dependent upon developments in syringe technologies and materials. Improvements to performance, product stability, convenience of use, and cost-effectiveness will stimulate increasing use of prefilled syringes and related devices this decade. Increased volume and viscosity-handling capabilities and launches of devices that are easier to use are already benefiting sales of the devices and filled products. According to the report, The advantages are great with prefilled syringes taking over from traditional formats. Prefillable syringes constitute one of the fastest growing markets in the drug delivery and pharmaceutical packaging industries. Drug Development & Delivery recently interviewed leading players in the prefilled syringe market to find out about their product or service offerings and how they are addressing pharmas needs for safety, ease of use, cost, and product differentiation.ALTHEA TECHNOLOGIESCRYSTALLIZED PROTEINS CREATE PATIENT-FRIENDLYDOSAGE & DELIVERYDrug Development & Delivery May 2012 Vol 12 No 4 Althea is a contract development and manufacturing organization that specializes in cGMP manufacturing, analytical development, aseptic filling into vials and syringes, and protein delivery technology for recombinant protein and parenteral products. The companys Altheas Crystalomics technology produces highly concentrated crystallized therapeutic proteins in suspension, creating a product with a more patient-friendly dosage and delivery format. Crystalomics improved product profile comes without creating a new biological entity. Crystallized proteins are a new state of the same molecule, albeit with improved stability and increased half-life. Once dissolved in the subcutaneous space, the therapeutic protein is identical to the protein inFIGURE 1 Syringes that can be filled on Altheas solution. Crystallization does not change the biochemical, structural, orxx large-scale high throughput syringe line for clinical to commercial development.
2. in vitro characteristics and behavior of the FIGURE 2protein. Therapeutic proteins in solutionand in crystals are considered differentformulations of the same biological entity.This makes crystallization technology anideal platform for producing BioSuperiortherapeutic properties. Superior second-generation biotherapies can be producedusing the same biological entity, the samebiological target, and the same diseaseindications. First-generation biotherapiescan be reformulated to give demonstrablepatient benefits covered under newintellectual property. Crystallized proteins can be formulatedup to 350 mgs/ml, allowing the conversionof low-concentration IV infusions, typicallyadministered in a hospital or doctors office, Syringe filling atto subcutaneous injections that canBaxters BioPharma Solutions facility.potentially be administered by the physicianor patient at home. The crystal formulationsIt appears to us that more products and cartridges, says Mahesh V Chaubal, .have low viscosity, allowing use of 29- are moving from vials to prefilledSenior Director, Drug Development,guage or narrower needles, limiting patient syringes, especially in the generic Baxters BioPharma Solutions. Thediscomfort. Additional technology allows biologics arena, says Mr. Hancock. This company has the automated assembly tofor increased serum half-life of short-lived can be a fairly easy differentiator if theconfigure the syringes with safety devices,proteins, decreasing the dosing frequency innovator product is a vial fill.such as BD PreventisTM, which is anfrom daily to weekly injections, and automatic needle-shielding systemincreasing patient convenience and designed to prevent needlestick injuries.compliance.BAXTERS BIOPHARMAIn addition to improving syringes for According to Althea President Rick SOLUTIONSADDRESSING patients, pharma companies see prefilledHancock, Althea spent the past yearDIFFERENTIATION &syringes as a way to set themselves apart.addressing the industrys rapid movementENHANCING COMPLIANCE The pharmaceutical industryto prefilled syringes. For instance, as the continues to move toward developingindustry trend is to move into a prefilledAs the prefilled syringe market maturesdifferentiated products, and often thissyringe earlier in the drug development into an established approach for enhancingdifferentiation is achieved via deliverycycle, Althea offers small-scale prefilled patient compliance in alternate settings, and devices, says Mr. Chaubal. Prefilledsyringe filling for stability studies and acts as a delivery differentiator, Baxter syringes are becoming a conventional Drug Development & Delivery May 2012 Vol 12 No 4small clinical trials through large-scale BioPharma Solutions has responded with aapproach of enhancing user friendliness ofhigh throughput for commercial supply. variety of packaging options, including a therapy, allowing for use in alternate There are also industry concerns prefilled syringes, cartridges, and flexiblesettings (such as home). Differentiation isabout glass delamination, breakage in containers for IV infusion. All these also expected to be a driving factor forsecondary devices, and biologic product configurations are designed for ease of use,biosimilars given that the recent FDAcompatibility, which have sparked an reduction in medication errors, and guidance for biosimilars appears to beinterest in polymer syringes. To meet this improved compliance.cognizant of the need for such devices. Weneed, Althea is filling polymer syringes onThe need to move from hospital to work with pharmaceutical and biotechits small-scale, semi-automated line and is alternate care settings (such as home use)companies to address their specific needs.developing a strategy for filling polymer has driven the industry toward user-Speaking of the FDA, Baxter has seensyringes on a large-scale automated filling friendly devices, such as prefilled syringesincreased scrutiny from the regulatoryline, explains Mr. Hancock. xx
3. FIGURE 3molecules that are labile and need suchMEDPRO SAFETYprotection during processing. PRODUCTS, INC.TURNING PREFILLED UPSIDE DOWN CATALENT PHARMAMedPro has been focused onSOLUTIONSBIOLOGIC protecting healthcare professionals throughDEVELOPMENT &innovative product design. The company FORMULATION introduced a platform of blood collection devices that offer the highest level of Catalent offers a diverse range ofneedlestick protection for the healthcareprefilled syringe products, specializedworker, with safety shield activation thatmanufacturing capabilities, and innovative occurs automatically to prevent the workerself-injection solutions such as auto- from being stuck with a contaminatedinjectors. Its syringe-filling capacity is needle. More recently, MedPro launched amore than 175 million units, and their drug delivery platform that has improvedfacilities are designed for the growingneedlestick protection features.biopharmaceutical market demand.MedPros Prefilled Cartridge can be Mike Riley, Vice President, Strategyused with its Safety Injection Syringe tofor Medication Delivery Solutions, automatically protect the healthcare workerDiverse range of prefilled syringe offerings byCatalent Pharma Solutions.Catalent Pharma Solutions, says that heand increase patient safety over a typicalsees two drivers in the prefilled syringevial delivery procedure, as well as decrease agency with respect to the functionality market. First, he believes prefilled syringesthe chance of contamination due to the and functional testing of prefilled syringes.will continue to be a key delivery form forreduced number of steps required for In response, Baxter has developedinjectable products, driven by the strongadministration. expertise for functional testing of syringes.drive toward patient self-administration, All of these devices lead to time- Responsiveness to customer needs alsoimproved safety and compliance, andsavings for the nurse, which is also drives enhancements at Baxter. dosing precision, particularly for higherimportant, says Garyen Denning,One example is that we havevalue products like biologics. Executive Vice President, MedPro Safety developed capabilities to fill syringes onlineWe see prefilled syringes as a key Products, Inc. For IV delivery, the same with completely disposable equipment topiece of a growing suite of Catalent prefilled cartridge is used, made of Type 1 help alleviate the concerns for cross- technologies that will allow us to bring glass or plastic, while the luer connection contamination, and we have developed and better treatments to market faster for our remains plastic. This helps to alleviate validated rigorous cleaning procedures,clients, he says. common concerns we see with glass luer which may be challenging for certain drug Second, due to the growing pipeline oftips breaking or having compatibility families, explains Mr. Chaubal. biologic therapies, Mr. Riley sees anissues in the marketplace.Baxters BioPharma Solutionsincreased demand for more sophisticated The need for better needlesti