Global Trends and Usage of Prefilled Syringes and Vials Gerresheimer RTF

Transcription

1 Global Trends and Usage of Prefilled Syringes and Vials Gerresheimer RTF Pharmtech Moscow November 2017 Nikolaus Netzel, Product Manager Prefillable Systems

2 Global Trends and Usage of Prefilled Syringes and Vials Gerresheimer RTF 1. Gerresheimer as a Company 2. Prefilled Syringe Market Trends 3. Gx RTF Product Portfolio & Latest Innovations November 2017 Global Trends and Usage of Prefilled Syringes and Vials 2

3 Gerresheimer 2016 A leading partner for the pharma & healthcare industry Revenues 2016: EUR 1,375m International presence: Europe, Americas, Asia High quality customer base: Global blue chip customers Employees: about 10,000 Head office: Duesseldorf, Germany Listing: Frankfurt Stock Exchange Percentage of revenues by market segment November 2017 Global Trends and Usage of Prefilled Syringes and Vials 3

4 Global player with strong regional footprint Europe USA Revenues 2016: EUR 1,375m Latin America Asia Regional footprint: Gerresheimer locations worldwide Europe USA Pharmerging markets (Quintiles IMS definition) Others November 2017 Global Trends and Usage of Prefilled Syringes and Vials 4

5 Our Organization with 2 divisions Plastics & Devices Andreas Schütte Primary Packaging Glass Christian Fischer November 2017 Global Trends and Usage of Prefilled Syringes and Vials 5

6 Gerresheimer Plastics & Devices Division: Medical Systems Medical Plastic Devices Pharmaceutical: inhalation, injection, pens, auto injectors Medical Technology: lancing devices, lancets, infusion sets, laboratory and molecular diagnostics, point-of-care testing, urology, surgery, dialysis and blood therapy Medical Systems Syringes/Cartridges Gx bulk syringes (glass) Gx RTF syringes (glass) Syringe components and accessories Gx pen cartridges ClearJect COP syringes Plastic Packaging Ophthalmic and rhinologic application systems Tablet containers, PET bottles Special closures November 2017 Global Trends and Usage of Prefilled Syringes and Vials 6

7 The Prefillable Syringe Market Some key figures Total PFS market 2016 > 3,0 Bil. pcs Markets by size: 1.EU; 2. USA, 3. China CAGR 5,1 % Staked in needle syringes are 2/3 of the market November 2017 Global Trends and Usage of Prefilled Syringes and Vials 7

8 Market requirements towards the primary packaging Sensitive formulation: reduced Tungsten: metal-free syringes and syringes with reduced tungsten residues Silicone oil: Gx Baked-on RTF syringes Glue residuals Glue-free: Gx RTF ClearJect Limit-value and detection method for glue leachables Extractables of elastomer parts: coating with fluoropolymers Tight barrel dimensions for Low dosage volumes Reduce overfill (costs) dead space measurements available Highly viscous: ease of administration Adapted cannulas Back stop / finger flange extension 2,25ml SIN syringes November 2017 Global Trends and Usage of Prefilled Syringes and Vials 8

9 Addressing current and future needs in Biotech, Ophthalmology and Home Use Needle cross section Tungsten pin Biotech: Higly viscous drugs Thin wall needles for better delivery Standard Thin wall Sensitive protein formulations - low tungsten and low silicone oil required Low tungsten specification Alternative pin materials Gx Baked-on RTF syringes T0 3 months Particles (free silicone oil) Gx Baked-on RTF Gx RTF Spray 186 Ophthalmology: Low volume for injection into the eye (intravitreal) Exact dose mark Very low particle load (USP requirement) Gx Baked-on RTF syringes November 2017 Global Trends and Usage of Prefilled Syringes and Vials 9

10 Addressing current and future needs in Biotech, Ophthalmology and Home Use Home Use with Auto-Injectors November 2017 Global Trends and Usage of Prefilled Syringes and Vials 10

11 Product Portfolio Parenteral packaging for the pharmaceutical industry

12 Our products: Syringes and pen cartridges Glass syringes: ready-to-fill Pen cartridges Gx RTF Gx pen cartridges Fields of application: Glass syringes: bulk Washed, siliconized, preassembled and sterilized (ethylene oxide) Cartridges for insulin (glass type I) Vaccines Heparins Biotec drugs Other applications Gx bulk No RTF-treatment Pen cartridges: Insulin Customized solutions November 2017 Global Trends and Usage of Prefilled Syringes and Vials 12

13 Gx RTF syringes (ready-to-fill): Syringe formats Luer cone Luer lock Staked-in needle 0.5 ml 1.0 ml long 1.0 ml standard 1.5 ml 2.25 ml 3.0 ml 1.0 ml long 1.0 ml standard 1.5 ml 2.25 ml 3.0 ml 0.5 ml 1.0 ml long 1.0 ml standard 1.5 ml 2.25 ml Customized syringe formats on request November 2017 Global Trends and Usage of Prefilled Syringes and Vials 13

14 Components and accessories Overview Closures Luer cone closure: Six Rip Tip Cap Luer lock closure: Tip Cap Gx TELC (Tamper Evident Luer Lock Closure) Cannulas Cannulas in steel-quality according to AISI 304 in different Length (½, ⅝ ) Diameters (23G, 25G, 26G, 27G, 29G) Grindings (3 bevel, 3 bevel XL, V bevel) Needle shields Flexible Needle Shields (FNS) Rigid Needle Shields (RNS) Proprietary Thermoplastic Elastomer Rigid Needle Shield (Gx TERNS ) Elastomer insert Contact surface to drug product Customized solutions November 2017 Global Trends and Usage of Prefilled Syringes and Vials 14

15 Components and accessories Overview Gx plunger rods Plunger rods in different Sizes (0.5 ml, 1.0 ml long, 1.0 ml short, ml, 3.0 ml) Colors Materials (polypropylene, polystyrene, polycarbonate) Gx backstops Backstops in different Sizes (0.5 ml, 1.0 ml long, 1.0 ml short - 3,0 ml) Colors Plunger stoppers Plunger stoppers in different Sizes (0.5 ml, 1.0 ml long, 1.0 ml short 3.0 ml) Materials (pharmaceutical elastomers, fluorpolymer coatings as an option) Qualities: bulk, ready-to-sterilize, ready-to-use From different suppliers Customized solutions November 2017 Global Trends and Usage of Prefilled Syringes and Vials 15

16 High quality cartridges Pen Cartridges Gx Cartridges Sizes from 1.5 to 3.0 ml, larger sizes up to 10.0 ml on request Visual inspection systems for 100 % dimensional control Designs according to DIN ISO ; customized formats on request Customized ceramic printing with heavy-metal-free inks Packaging options: PP-box, other options on request Suited to standard filling and packaging equipment Drug Master File Type III November 2017 Global Trends and Usage of Prefilled Syringes and Vials 16

17 Gx RTF Metal free Syringe Issue: Tungsten pin used for luercone bore forming Tungsten residues (particles/oxides) can interact with proteins Solution: Tungsten pin used to dimension inner bore of the syringe cone replaced by ceramic pin No tungsten detectable in syringe cone and body No ceramic residues or particles Ceramic material complies to ISO EDX measurements confirmed absence of any peaks caused by ceramics November 2017 Global Trends and Usage of Prefilled Syringes and Vials 17

18 Gx BakedOn RTF staked in needle syringes Issue: Silicone oil used as a lubricant emits particles which can cause protein aggregation Solution: Reduce free silicone oil particles fixating the silicone oil by heat treatment, so called baked on process Silicone oil particle load especially in the subvisble range drastically reduced maintaining lubricity required for syringe functionality Unique offering of baked on technology for staked in needle syringes Particles 10 μm (up to 25 μm) WFI as diluent November 2017 Global Trends and Usage of Prefilled Syringes and Vials 18

19 Gx InnoSafe Issue: Existing safety devices to prevent needle stick injuries require additional assembly steps during secondary packaging Solution: Fully integrated system with fully passive safety function Delivered pre-assembled in nest and tub Commercially available elastomer formulations for closure part adaptable Small package size Drug fully inspectable Confident and intuitive appearance Preventing from Needlestick Injuries November 2017 Global Trends and Usage of Prefilled Syringes and Vials 19

20 Gx InnoSafe Packaging scheme Standard tub Standard nest 100 Sealed with Tyvek layer Single or double steri bag Sterilization with ethylen oxide (ETO) Compatible with existing fill & finish equipment Start of series production in 2020 November 2017 Global Trends and Usage of Prefilled Syringes and Vials 20

21 Gx RTF ClearJect Issue: Glass can break which may be a disadvantage for certain device applications Glass can interact with the drug product Solution: Use of cyclic olfine polymers with glass like transparency Use of standard rubber components With needle syringes properties Free of tungsten Free of glue Break resistant Easier customization GX RTF ClearJect with needle syringe November 2017 Global Trends and Usage of Prefilled Syringes and Vials 21

22 Gx RTF Vials powered by EZ-fill packaging components provide added value to the customer by sourcing one vial from two suppliers packed identically. Ready to use vials are washed and sterilized solutions provided packed in trays or in nests and tubs November 2017 Global Trends and Usage of Prefilled Syringes and Vials 22

23 Gx RTF Vials Delivered sterile Flexibility for a variety of filling and sealing technologies Improvement of the total manufacturing costs over the product life cycle Combined know-how in glass forming, processing of prefillable primary packaging materials and packaging technology two manufacturers one packaging Flexibility through different packaging configurations from the development phase of new medications through the small series to large series production The highest standards with regard to glass breakage, cosmetic defects, and particle contamination Availability Product specifications for 2R, 6R and 10R vials Product samples in 2018 Start of series production in 2019 November 2017 Global Trends and Usage of Prefilled Syringes and Vials 23

24 Standardizing Gx RTF Vial packaging Gx glass vials in unique quality ISO 8362 standard or customized dimensions Borosilicat Type I Washed with WFI (water for injection) Subvisible particle specification Endotoxin specification Capable for nest filling E.g. combi/multi filling lines for syringes, cartridges and vials Different types of RTF filling line concepts are available which can process the format No glass to glass contact Standardized packaging powered by Sterilized with Ethylen Oxide (EtO) gas according to ISO Neck up: For small scale filling in laboratories Bottom up: For high scale traditional filling equipment November 2017 Global Trends and Usage of Prefilled Syringes and Vials 24

25 Gx MDS value proposition with regard to RTF syringes Biocompatibility Glue residuals Tungsten oxides Silicone oil particles Plastic PFS (COP),Gx ClearJect Low tungsten & metal free option BakedOn RTF Luer Cone Baked On RTF Stakedin Syringes End user safety Device compatibility TCO RNS (West, Stelmi, Datwyler) Proprietary closure systems Safety solutions Tight dimensional specification For AI use: siliconisation, FF hardness and design Low cosmetic defects Low particle load TELC (Luer lock closure) TERNS TPE RNS Gx Innosafe Syringe Modern glass forming technology Proprietary G3 camera system Finger flange and cone design Valor glass Proprietary G3 camera system State of the art RTF lines Modern glass forming technology (in house) Washing machine after forming November 2017 Global Trends and Usage of Prefilled Syringes and Vials 25

26 Спасибо Any questions?

27 Contact Михаил Синицын Россия, Москва, Ленинградское шоссе, д.25 корп (495) office@emb-pharma.ru Nikolaus Netzel Product Manager Gerresheimer n.netzel@gerresheimer.com November 2017 Global Trends and Usage of Prefilled Syringes and Vials 27

28 Our Vision Gerresheimer will become the leading global partner for enabling solutions that improve health and well-being. Our success is driven by the passion of our people.