more expertise. customized solutions. reliably supplied.
sterile technologies
DEVELOPMENT
DELIVERY
SUPPLY
CUSTOMIZED OPTIONS FOR COMPLEX TREATMENTS With our diverse range of parenteral delivery platforms and proven expertise in specialized manufacturing challenges, we can tailor a solution for your unique needs.
your specialized sterile manufacturing challenges, our tailored solutions. With our diverse range of parenteral delivery platforms, including pre-filled syringes and blow/fill/seal technology, we create tailored solutions for your most difficult challenges. The combination of our extensive drug and biologic manufacturing, filling and packaging capabilities ensures that we can offer customized options for each of our customers and supply their products to market reliably.
Blow/ Fill/ Seal Technology
PRE-FILLED SYRINGES
As the leading provider of blow/fill/ seal technologies, we have over 30 years of experience in providing endto-end unit and multi-dose solutions with the highest level of quality.
As a market leader in sterile manufacturing, we offer an extensively customizable range of pre-filled syringe products, uniquely tailored for each customer.
Pre-formulation through Commercialization Our experts can work with your products from preformulation development, through commercial manufacturing and beyond. We specialize in the preformulation of complex products including eye emulsions, viscous and potent suspensions.
Customized Products in Ready to Fill or Bulk Syringes We offer a range of pre-filled syringe sizes (0.5ML to 50ML), tops (luer, luer lock or with needle), graduation and aseptic/terminal sterilization.
Flexible Solutions We have the scale, capacity and flexibility to offer cost-effective solutions for projects ranging from large, commercial-scale production down to low-volume, smallbatch sizes needed for clinical trials.
Flexible Capacity A global network with dedicated lines and capabilities to handle projects from the very small to the very large, up to 200 million units.
Integrated, Reliable Supply We have delivered customized global manufacturing, packaging and integrated supply solutions to the top innovators for over 30 years.
Unique Capabilities for High Viscosity Support for the Right Viscosity Levels Up to a maximum level of viscosity of 5,000,000cp at 0,1s-1 at 25°C (equivalent to 5,000 Pa.s). Capacity to Handle the Largest Challenges Ability to fill and package 1ml, 10ml, 20ml, 50ml, up to 100ml syringes, with the capacity to fill over 8 million highly viscous syringes per year. Turnkey Services Including terminal sterilization, labeling, blistering and cartoning.
Unique Filling Capabilities Including dedicated product lines for complex, highly viscous filling.
Integrated Services Fully integrated services including labeling, blistering and cartoning of injectable products. FLEXIBLE BAGS Our flexible bag-filling capabilities allow us to provide customizable, specialty solutions that efficiently drive effective patient outcomes by delivering the right dose, safely and reliably. Diverse Range of Offerings Extensive filling and packaging of flexible bags, ranging in size from 250ml to 3,000ml for aseptically-filled Ethylene Vinyl Acetate (EVA) bags and 40ml to 5,000ml for terminallysterilized Polyvinyl Chloride (PVC) and Polypropylene (PP) bags. Ability to Solve Complex Challenges Including dual chamber IV bags for working with complex or multiple liquid compounds. Turnkey Services Labeling, blistering and cartoning of flexible bag products.
Discover more solutions with Catalent. Call: + 1 866 720 3148 Email:
[email protected] Visit: www.catalent.com
MARKET-LEADING EXPERTISE WITH BLOW/FILL/SEAL TECHNOLOGY Complimenting the most flexible blow/fill/seal manufacturing capability in the industry, we have the proven expertise in providing customized solutions from development through commercialization. Our innovative technology delivers dosing solutions for the respiratory, ophthalmic, biologics and oral liquid markets.
SAFER, MORE ACCURATE DOSING Our expertise with specialized delivery technologies, such as unit and multi-dose blow/fill/seal configurations and Bespak’s ASI™ autoinjector platform, enhances product performance and provides more convenient, safer dosing to improve patient outcomes.
Bringing Better Treatments to Market
Lower your Product’s Risk Profile
As the leading provider of blow/fill/ seal technology solutions, our offerings are wide in scope and usage. We are proud to use this unit- and multidose delivery platform to solve our customers’ unique product challenges.
Combining our scientific expertise with the sophisticated automation behind blow/fill/seal technology and our relentless focus on quality, Catalent is committed to ensuring our customers’ success.
Through our diverse range of injectable delivery platforms, unit and multi-dose blow/fill/seal configurations, and our innovative self-injection solutions in collaboration with Bespak, we can enhance product performance and provide more convenient, safer dosing options to improve patient outcomes.
Used Across Many Therapeutic Areas Innovative blow/fill/seal technology delivers dosing solutions in the respiratory, ophthalmic, biologics, oral liquid, topical, medical device markets, and many more.
World-class Expertise We have expertise working with complex products including eye emulsions, viscous suspensions and products that are light and oxygen sensitive.
Pre-formulation Expertise Our experts will work with your products from pre-formulation through commercial scale, providing expertise, manufacturing and integrated packaging solutions. Completely Customizable In-house container design and component insertion capabilities allow complete customizability for unit-dose or multidose products without reliance on stock containers. For both traditional or complex unit dose solutions. Flexibility & Capacity We have a long history of successfully taking customers from development through commercialization, leveraging our scientific talent, operational flexibility and extensive capacity to solve unique challenges and reliably supply product globally.
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Highly Efficient Process Highly automated, minimizing component handling and pre-sterilization steps, allowing high per-run output and maximum process efficiency. High Quality Output Recognized by the USP as an advanced aseptic process for forming, filling and sealing containers. Process features minimal operator interface and limited product exposure time, thus helping minimize risk.
EXTENSIVE RANGE OF PRE-FILLED SYRINGES Our solutions offer increased efficiencies, accurate dosing, and convenient single-dose administration of your injectable products. Safety Unlike multi-dose vials, prefilled syringes require no preservatives, which can trigger allergic reactions in some patients. Pre-filled single-dose syringes also reduce the likelihood of medication dosing errors.
BLOW/FILL/SEAL PROCESS blow/fill/seal is the combination of three major processing steps: 1 container molding, 2 container filling and 3 container sealing. within a single contained process. the advanced aseptic process is a highly automated system with minimal operator interface. the plastic extrusion area and critical fill zone (iso.5) are designed as partially isolated areas with localized protection where exposure of the product and container to the environment is minimized.
Convenience Our pre-filled syringe solutions provide an accurate single dose of your drug product in a convenient, ready-to-use format. Cost Efficiencies Each pre-filled syringe delivers a precisely measured dose, eliminating the overfill and wasted product associated multi-dose vials – a significant cost savings for manufacturers and biologics customers. Reimbursement The growing trend in healthcare reimbursement supports in-home care of chronic diseases rather than more costly outpatient treatment. Delivery devices, such as the ASI™ autoinjector platform, provide enhanced ease of use for health care providers and facilitate self-administration of injectable medications.
INNOVATIVE SELFINJECTION SOLUTIONS Catalent and Bespak, two of the most respected names in drug delivery, have collaborated to provide innovative self injection solutions. Through our partnered approach, we provide flexible, high performance autoinjector options backed by deep expertise and integrated reliable supply. Both the ASI™ autoinjector technology platform and the new OTS™ autoinjector device provide simple, cost-effective solutions for self-injection. Experienced Over 100 years of combined experience in providing drug delivery technologies for the global pharmaceutical industry. Cost-effective Autoinjector devices, syringe filling, device assembly and packaging provide economic solutions for final product supply. Responsive Manufacturing and supply of autoinjector devices from pilotscale through commercial supply, with full supply chain management.
VACCINES We are a leading provider of pre-filled syringes for vaccines and work with most of the leading vaccine producers every season. • Unmatched surge capacity potential for nearly every major dose form • Demonstrated capability to scale up in support of pandemic demand • Broad geographic footprint and operational flexibility
Discover more solutions with Catalent. Call: + 1 866 720 3148 Email:
[email protected] Visit: www.catalent.com
INTEGRATED, RELIABLE SUPPLY We improve speed to market through efficient, integrated solutions and provide customers with peace of mind by following the highest quality standards in the industry.
With our tailored integrated solutions, we can accelerate and create efficiencies throughout your supply chain from drug delivery to packaging to supply. Whether you are seeking assistance with a single service area or an end-to-end partner, our team of scientific, regulatory, manufacturing and operations professionals can develop a tailored proposal that will put you on track to faster, more efficient drug development and commercialization pathways. BIOLOGICS We are your strategic partner for biologic drug development success. With our GPEx‰ technology for mammalian cell line development and our broad range of integrated services, we provide fast, seamless solutions from development to biomanufacturing, analytical, fill/finish and packaging. ANALYTICAL SERVICES From rapid testing of early candidates to new drug application/registration submission and post-launch, we have the broadest range of analytical testing services to help accelerate your drug development project and provide immediate resourcing and expert technical support. With our problem-solving expertise, stateof-the-art systems and proprietary technologies, we have constructed a strong continuum of analytical services to support your small or large molecule drug development needs.
STERILE DRUG MANUFACTURING Our mastery of aseptic manufacturing and diverse range of delivery technologies, including blow/fill/ seal and pre-filled syringes, make us uniquely suited to support your complex products.
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STERILE PACKAGING A broad range of sterile packaging solutions can be integrated with our global manufacturing options for a tailored integrated solution that helps to optimize your supply chain, reduce cycle time and inventory levels, simplify release and invoicing procedures for lower overall supply chain costs.
Catalyst + Talent. Our name combines these ideas. From drug and biologic development to delivery technologies and supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most innovative technologies in brand and generic pharmaceuticals, veterinary medicine, consumer health, and biologics. Whether you are looking for a single, tailored solution or multiple answers throughout your product’s lifecycle, we can improve the total value of your treatments—from discovery to market and beyond. Catalent. More products. Better treatments. Reliably supplied.™
REGULATORY CONSULTING With over 50 years of experience in developing pharmaceutical products across a wide range of therapeutic areas for global markets, we help you maximize your product value with expert solutions to development issues. From preclinical to life-cycle maintenance, we ensure accurate, timely regulatory submissions to help minimize product development timelines and maximize probability of success.
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woodstock, il
brussels, belgium
· Blow/Fill/Seal Technology
· Pre-filled Syringes
· Ophthalmic · Respiratory · Unit or Multi-dose
· Vaccines · Autoinjectors · High Filling Capacity/Speed
DEVELOPMENT
DELIVERY
SUPPLY
biologics pre-formulation & formulation solid state services pharmaceutical & biopharmaceutical lab services regulatory consulting
softgel vegicaps ® capsules controlled release zydis ® & lyopan ® fast dissolve osd r c ® optidose ™ hot melt extrusion inhalation injectables
clinical supply manufacturing blow/fill/seal sterile fill/finish packaging services & delivery solutions
· Development through Commercial Manufacturing
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rtp, nc
limoges, france
· Small Scale Vials
· High Volume PFS
· Small Scale Syringes
· Highly Viscous PFS
· Lyophilization
· IV Bags
· Biopharmaceutical/ Sterile Development
To learn more about Catalent Sterile Technologies, contact us today. www.catalent.com/fillfinish
Discover more solutions with Catalent. Call: + 1 866 720 3148 Email:
[email protected] Visit: www.catalent.com
more products. better treatments. ™ reliably supplied. Challenge us. Let us help you get your products to market faster, stay there longer, and be more successful. Catalent Pharma Solutions. We are the catalyst for your success. Catalent Pharma Solutions 14 Schoolhouse Road Somerset NJ 08873 USA T +1 866 720 3148 F +1 732 537 6480 www.catalent.com
[email protected] Optidose is a trademark of Catalent Pharma Solutions GPEx and Zydis are registered trademarks of Catalent Pharma Solutions Lyopan is a registered trademark of Pantec AG ASI and OTS are trademarks of Bespak Europe, Ltd. ˝ Copyright 2011 Catalent Pharma Solutions, Inc. All rights reserved Lit. No. ST-STBR-BRV2 (10/11)
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