Vetter Packaging Solutions

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1 A uique bled of resources for fillig ad packagig Vetter Packagig Solutios Deliverig your product s potetial Aswers that work 1

2 Thik outside the vial. Vetter packagig experts help you optimize your product s safety, quality, ad potetial. How should your ijectable drug be delivered ad packaged? At every stage of growth, there are may questios to cosider from esurig material compatibility ad compoud stability to meetig the growig demad for user-friedly systems. As a dedicated strategic parter, Vetter Packagig Solutios ca help you idetify ad develop the right strategies for your compoud throughout its life cycle. Discover how we ca support your success from cliical developmet through full market supply. Formulatio support Process developmet Cliical trial maufacturig Aalytical services Regulatory support Fill ad fiish Aalytical services Regulatory support Product life cycle maagemet Customized packagig developmet Specialized techologies Prove platform techologies Packagig services Logistic services About Vetter Packagig Solutios Vetter Packagig Solutios is a service of Vetter, a idepedet, familyowed compay with more tha 35 years of experiece i aseptic, high-quality maufacturig of ijectable products. Recogized as oe of the world s leadig CDMOs, Vetter is proud to work with today s Top 20 pharmaceutical ad biotech compaies. 2

3 Customized packagig developmet The right place to start for log-term results. For may products, packagig decisios require careful plaig ad i-depth kowledge of complex issues that ca affect cliical performace ad market success. Vetter works closely with your team to create packagig solutios that reflect your compoud s specific challeges ad opportuities. Whether your product is a fragile ew compoud or a established ijectable i a challegig market, our specialists ca help you select the ideal ijectio system ad materials for your compoud s characteristics get i-depth advice o importat cosideratios i primary ad secodary packagig develop custom packagig solutios that help optimize ed-user coveiece ad productio efficiecies Packagig cofidece With the rapid growth of advaced treatmets for chroic illesses ad icreased demad for user-friedly systems, ijectable packagig is ow uder tighter regulatory scrutiy to esure patiet safety. At Vetter, you ca be sure that the safety ad itegrity of your packagig will be carefully plaed from the start ad i full compliace with cgmp guidelies for the US, Europe, ad Japa. 3

4 Specialized packagig techologies Solutios that set you apart. Followig lauch, your product ca face a variety of cliical, ecoomic, ad competitive challeges. Vetter ca help you reshape its potetial with a uique portfolio of specialized packagig solutios as part of a life cycle maagemet program. Dual-chamber systems: oe-of-a-kid coveiece Vetter s pateted dual-chamber techology allows differet igrediets ad solvets to be prefilled ad stored separately, the easily mixed ad admiistered as eeded. Dual-chamber systems ca be used for lyophilized/ solvet drugs, ad liquid/liquid drugs ad offer your sesitive compoud may advatages. Example: Vetter Lyo-Ject dual-chamber syrige 1.0 ml Simple admiistratio fewer compoets required vs traditioal vial/syrige combiatios Icreased patiet safety allows precise dosig ad helps miimize recostitutio errors High product security systems are closed iside the lyophilizer Versatility dual-chamber cartridges ca be used for sigle- ad multidose pe applicatios Low residual volume closure system ad stopper geometry desig reduce overfill ad miimize packagig waste 4

5 Vetter-Ject syrige closure system: desiged for today s compouds The Vetter-Ject closure system offers the coveiece of a syrige i a desig that addresses the uique requiremets of highly sesitive compouds. Combiatio of a itegrated staked eedle with a baked-i silicoizatio process for stadard glass barrels Heat tuel sterilizatio for edotoxi-free glass barrels Tamper-evidet closure supports product itegrity Prefilled syrige offers coveiet admiistratio for patiets ad cliicias Flexibility across the process, compoets, ad packagig V-OVS tamper-evidet closures: streamlied security The V-OVS closure icludes a tamper-evidet seal that provides additioal protectio for your glass-barrel syrige ad is suitable for syrige formats with a Luer coe ad groove. Efficiet productio o existig aseptic equipmet meas miimal chage to process flow Easy hadlig 3 simple elemets iclude a tamper-evidet seal, tip cap, ad Luer lock Versatility compatible with multiple autoijector systems, vial adapters, eedle legths, ad Luer coectors Safety devices: simplifyig eedle stick protectio To help protect patiets ad cliicias from ijuries such as eedle sticks, sigle-chamber syriges with staked eedles are available assembled withi a safety device. Bulk glass syriges: optimized flexibility Bulk glass syriges allow specific silicoizatio ad sterilizatio processes to be tailored to your compoud s uique requiremets, with added flexibility i primary compoet assembly. Maufacturig is processed i place to miimize cotamiatio risks, with o trasfer out of sterilized grade A uits. 5

6 Vetter combiatio products: expadig your versatility Vetter s combiatio systems help you deliver your drug i a variety of formats that are particularly useful i the home health care settig. Sigle-chamber cartridges for pes ad pump systems Dual-chamber cartridges for pe systems Sigle-chamber syriges for autoijectors Example: Ypsomed, LyoTwist Trio Polymer syriges for sesitive molecules For biologics ad other complex substaces that are highly sesitive to glues ad tugste, ask Vetter about polymer systems. Ideal for use with autoijectors tight dimesioal specificatios help achieve cosistet glide-force behavior, providig precise, cosistet drug delivery from dose to dose Break-resistat material icreases patiet safety ad miimizes product loss durig hadlig ad applicatio 6

7 Prove platform techologies Simple solutios, high-quality results. Whe covetioal delivery systems are best suited to your product eeds, Vetter offers high-quality aseptic fillig of both stadard vials ad presterilized/ested glass syriges. Vials for liquids ad lyophilized products are available i fillig volumes up to 50 ml Sigle-chamber glass syriges for liquid products are available with Staked eedles ad fillig volumes from 0.1 ml to 3 ml Luer lock caps ad fillig volumes from 0.1 ml to 20 ml Example: Blistered swfi-syrige 3.0 ml Sterile Water for ijectio (swfi) syriges: built-i coveiece swfi syriges for recostitutig lyophilized products offer uique advatages at all stages of your product s life cycle. Fast time-to-market Vetter offers ready-to-submit documetatio for Europe, US ad Japa as well as stability data to streamlie registratio Turkey simplicity flexible fillig rages from 0.5 ml to 3 ml (1.5 ml ad 3 ml formats) ad premium-quality packagig materials, icludig customized coveiece kits Market-differetiatig coveiece All-i-oe swfi syriges ca simplify the recostitutio process ad help to improve patiet compliace 7

8 Packagig services Broad flexibility, precise quality stadards. Secodary packagig has become a critical part of pareteral maufacturig. Vetter s itegrated packagig services help you meet icreased safety ad quality requiremets with a broad meu of well-desiged, efficiet solutios. All of our packagig services are housed withi a state-of-the-art facility with separate productio ad utility areas o each floor. Assembly A comprehesive meu of services icludes complete assembly of all syrige compoets assembly of safety devices, pes, ad autoijectors Pritig ad labelig Choose from a broad rage of optios, such as variable data pritig for packagig ad cartos compoet labelig special services, such as vigettes serializatio ad aggregatio services Customized coveiece Vetter supports your product with both sigle-source efficiecy ad exceptioal flexibility. All of our packagig services ca be tailored to meet your specific eeds, from cliical trials through full commercial productio. 8

9 Blister packig ad cartoig I additio to packig blisters i cartos, we offer thermoformig i various formats customized carto assembly tamper-evidet carto labels (icludig isertio of leaflets ad other materials with your product) layout desig services Serializatio Services We offer a comprehesive portfolio of serializatio services, icludig aggregatio with various customized ad flexible optios that allow you to meet regulatory requiremets. Through our service offerigs, you have the basis for the implemetatio of track-ad-trace systems that ca achieve greater security ad efficiecy of your supply chai. Shippig packagig ad storage Fial product ca be packed for shipmet per your specificatios or stored uder precise GMP coditios, icludig room temperature storage (15 25 C) cold cotrolled storage (2 8 C) Itegrated safety, quality, ad hygiee protocols Vetter s packagig ad fillig operatios comply with cgmp guidelies for the US, Europe, ad Japa. Our facilities iclude cotrol systems for each process step to help esure cosistecy ad accuracy. We also offer specialized productio techology for products with high cosmetic requiremets. 9

10 Vetter Packagig Solutios A overview of fillig ad packagig optios. Vetter s ijectable delivery systems are available i a wide array of cofiguratios to meet your product- ad patiet-specific eeds. Device Type Closure Sigle-chamber syrige Bulk Presterilized swfi Staked eedle V-OVS /tip cap Staked eedle Luer lock V-OVS Bulk Vetter-Ject Dual-chamber syrige Bulk V-OVS Sigle-chamber cartridge Bulk Crimp cap Dual-chamber cartridge Bulk V-LK Vial Bulk Crimp cap Flip-off cap 10

11 Packagig ad assembly services: System ad compoet optios Possible fillig volume Dosage form Dosage format Syrige optios Autoijector Safety device Pe system 0.1 ml 1.1 ml 0.1 ml 10 ml 0.1 ml 3 ml Liquid Multiple ml formats Pluger rods 0.1 ml 20 ml Backstops 0.5 ml 3 ml Water for ijectio 1.5 ml 3 ml 0.1 ml 1.5 ml Liquid 1.5 ml/1 ml log Pluger rods Backstops Diluet Chamber: ml Dosage volume 5 ml max (depedig o dosage format) Dosage volume (both chambers): 5.6 ml max (depedig o dosage format) Lyophilized/ liquid Liquid/ liquid 1 ml 2.5 ml 5 ml Pluger rods 0.1 ml 5 ml Liquid Multiple ml formats Diluet Chamber: ml Dosage volume 1 ml max (depedig o dosage format) Dosage volume (both chambers): 1 ml max (depedig o dosage format) Lyophilized/ liquid Liquid/liquid 1 ml 0.1 ml 50 ml Lyophilized Liquid Multiple ml, R, ad other formats All devices Kit packagig, pritig, labelig, blisterig, cartoig, shippig, packagig, serializatio, aggregatio ad cold/room temperature storage 11

12 For further iformatio, please get i touch with us Vetter Pharma Iteratioal GmbH Eywiesestrasse Ravesburg Germay phoe: +49-(0) fax: +49-(0) ifo@vetter-pharma.com Vetter Pharma Iteratioal USA Ic Searle Parkway, Suite 300A Skokie, IL USA phoe: fax: ifous@vetter-pharma.com Vetter Pharma Iteratioal GmbH Sigapore Brach The Metropolis, Tower 2 Level 8 Uit-09, North Buoa Vista Drive Sigapore phoe: ifoasiapacific@vetter-pharma.com Vetter Pharma Iteratioal Japa K.K. Level 28 Shiagawa Itercity Tower A Koa Miato-Ku Tokyo Japa phoe: ifojapa@vetter-pharma.com Vetter Pharma Iteratioal GmbH South Korea Brach #1106 Get-Pearl Tower, 12 Gaetbeol-ro Yeosu-gu, Icheo Korea phoe: ifoasiapacific@vetter-pharma.com Aswers that work