more expertise. customized solutions. reliably . · pdf filemore expertise. customized...

5
more expertise. customized solutions. reliably supplied. DEVELOPMENT DELIVERY SUPPLY sterile technologies

Upload: duongtruc

Post on 16-Mar-2018

219 views

Category:

Documents


1 download

TRANSCRIPT

Page 1: more expertise. customized solutions. reliably . · PDF filemore expertise. customized solutions. reliably supplied. ... packaging and integrated supply ... terminal sterilization,

more expertise. customized solutions. reliably supplied.

DEVELOPMENT DELIVERY SUPPLY

sterile technologies

Page 2: more expertise. customized solutions. reliably . · PDF filemore expertise. customized solutions. reliably supplied. ... packaging and integrated supply ... terminal sterilization,

CUSTOMIZED OPTIONS FOR COMPLEX TREATMENTSWith our diverse range of parenteral delivery platforms and proven expertise in specialized manufacturing challenges, we can tailor a solution for your unique needs.

BLOw/ FILL/ SEaL TEchNOLOgY

As the leading provider of blow/fill/seal technologies, we have over 30 years of experience in providing end-to-end unit and multi-dose solutions with the highest level of quality.

Pre-formulation through commercialization Our experts can work with your products from pre-formulation development, through commercial manufacturing and beyond. We specialize in the pre-formulation of complex products including eye emulsions, viscous and potent suspensions.

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, small-batch sizes needed for clinical trials.

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

SupportfortheRightViscosityLevelsUp to a maximum level of viscosity of 5,000,000cp at 0,1s-1 at 25°C (equivalent to 5,000 Pa.s).

CapacitytoHandletheLargestChallenges 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.

TurnkeyServices Including terminal sterilization, labeling, blistering and cartoning.

DiscovermoresolutionswithCatalent. Call: + 1 866 720 3148 Email: [email protected] Visit: www.catalent.com

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.

PRE-FILLED SYRINGES

As a market leader in sterile manufacturing, we offer an extensively customizable range of pre-filled syringe products, uniquely tailored for each customer.

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.

Unique Filling capabilities Including dedicated product lines for complex, highly viscous filling.

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 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 terminally-sterilized 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.

Page 3: more expertise. customized solutions. reliably . · PDF filemore expertise. customized solutions. reliably supplied. ... packaging and integrated supply ... terminal sterilization,

1

2

DiscovermoresolutionswithCatalent. Call: + 1 866 720 3148 Email: [email protected] Visit: www.catalent.com

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.

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.

EXTENSIVE RANGE OF PRE-FILLED SYRINGESOur solutions offer increased efficiencies, accurate dosing, and convenient single-dose administration of your injectable products.

Safety Unlike multi-dose vials, pre-filled 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.

Convenience Our pre-filled syringe solutions provide an accurate single dose of your drug product in a convenient, ready-to-use format.

CostEfficiencies 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 SELF-INJECTION SOLUTIONSCatalent 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 pilot-scale through commercial supply, with full supply chain management.

MARKET-LEADING EXPERTISE WITH BLOW/FILL/SEAL TECHNOLOGYComplimenting 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.

BRINGING BETTER TREATMENTS TO MARkETAs 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 multi-dose delivery platform to solve our customers’ unique product challenges.

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.

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 multi-dose 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.

LOWER YOUR PRODUCT’S RISk PROFILECombining 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.

world-class Expertise We have expertise working with complex products including eye emulsions, viscous suspensions and products that are light and oxygen sensitive.

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.

BLOw/FILL/SEaL PROcESS blow/fill/seal is the combination of three major processing steps: 1container 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. 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

3

Page 4: more expertise. customized solutions. reliably . · PDF filemore expertise. customized solutions. reliably supplied. ... packaging and integrated supply ... terminal sterilization,

To learn more about Catalent Sterile Technologies, contact us today.

www.catalent.com/fillfinish

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.™

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.

3

4

21

woodstock, il

· Blow/Fill/Seal Technology

· Ophthalmic

· Respiratory

· Unit or Multi-dose

· Development through Commercial Manufacturing

rtp, nc

· Small Scale Vials

· Small Scale Syringes

· Lyophilization

· Biopharmaceutical/Sterile Development

brussels, belgium

· Pre-filled Syringes

· Vaccines

· Autoinjectors

· High Filling Capacity/Speed

limoges, france

· High Volume PFS

· Highly Viscous PFS

· IV Bags

1

2

3

4

DiscovermoresolutionswithCatalent. Call: + 1 866 720 3148 Email: [email protected] Visit: www.catalent.com

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, state-of-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.

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.

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.

DELIVERYsoftgelvegicaps® capsulescontrolled releasezydis® & lyopan® fast dissolveosdrc® optidose™

hot melt extrusioninhalationinjectables

SUPPLY clinical supplymanufacturingblow/fill/sealsterile fill/finishpackaging services & delivery solutions

DEVELOPMENTbiologicspre-formulation & formulationsolid state servicespharmaceutical & biopharmaceutical lab servicesregulatory consulting

Page 5: more expertise. customized solutions. reliably . · PDF filemore expertise. customized solutions. reliably supplied. ... packaging and integrated supply ... terminal sterilization,

8

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.

CatalentPharmaSolutions14 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 SolutionsGPEx and Zydis are registered trademarks of Catalent Pharma SolutionsLyopan is a registered trademark of Pantec AG ASI and OTS are trademarks of Bespak Europe, Ltd.

˝ Copyright 2011Catalent Pharma Solutions, Inc.All rights reserved

Lit. No. ST-STBR-BRV2 (10/11)