Contract Manufacturing



Similar documents
How To Test For Leachables

National Patient Safety Agency. Risk Assessment of Injectable Medicines. STEP 1 Local Risk Factor Assessment. STEP 2 Product Risk Factor Assessment

Liquids Suspensions Gels

Cyto-Set. Safer cytostatic preparation and application. IV Administration

STABILITY TESTING: PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

Overcoming Challenges in the Manufacturing of Pre-Filled Syringes. Farvea, a new comer in the PFS world PFS Tech June 2016 pharma@fareva.

Manufacturing Services. Operational solutions for chemical, pharmaceutical, nutraceutical and cosmetic companies

Position Paper (II) Healthcare Provider Advisory Council Implementation in hospitals hindered by bar code symbol issues

Pharmaceuticals Production Services Boehringer Ingelheim. Our expertise in world-class contract manufacturing for your success

STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

NEW CHEMICAL ENTITIES

IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES. A trusted source for all of your global comparator needs

Washing. Sterilising. Filling. Closing. Inspecting. Labelling

Disposables the Original by B. Braun

MATRIX GEMINI LIMS AT WORK IN THE FOOD INDUSTRY

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

Valentina Gualato, Ph.D. Process Development Scientist

TransCelerate's Role in Transforming Pharmaceutical Trials Presentation to PCORNet

Go for the complete package.

About Siegfried. Company Portrait

Cardinal Health Specialty Solutions. Cardinal Health Geographic Insights Maximize Market Opportunity with Actionable Insights from Data Visualization

Express services and solutions

Pen Injectors to 2022

Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products

Siemens Industry Automation Division

Taking Strategic Partnerships to the Next Level: An Alternative Approach to Licensing Your Development Asset

Guidance for Industry

Pharmaceutical Quality Management System: Current Concept

PEOPLE > SCIENCE > SOLUTIONS

REFERENCE CODE GDHC269DFR PUBLICATION DATE JULY 2013 PREMARIN (POSTMENOPAUSAL VAGINAL ATROPHY) - FORECAST AND MARKET ANALYSIS TO 2022

Recommendations for the Safe Use of Handling of Cytotoxic Drugs

Health Canada Manufacturing and Compounding Drug Products in Canada: A Policy Framework Guidelines for P.E.I. Community and Hospital Pharmacists

ORGANIC SAMPLE PREPARATION

Mayo Central Laboratory for Clinical Trials A Division within Mayo Clinical Trial Services

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

Combination Products. Presented by: Karen S. Ginsbury For: IFF March PCI Pharma

packaging solutions for temperature sensitive shipments

TEMPLATE DATA MANAGEMENT PLAN

GAM. Out management company services

Aseptic preparations, including TPN, for a limited number of patients

INTRODUCING THE NEW. Xcelodose S. New Powder Micro-dosing System. Even Faster Time to First in Man

Making healthcare run more effectively

LFB GROUP & SANOFI combine their bioproduction capabilities to provide integrated CMO services for biopharmaceuticals

ICH Topic Q 1 A (R2) Stability Testing of new Drug Substances and Products. Step 5

Annex 7 Guidelines on pre-approval inspections

Working with ICH Quality Guidelines - the Canadian Perspective

Pharmaceutical Waste Management Program St. Joseph Mercy Oakland. Pharmacy/Patient Care

A Stability Program for the Distribution of Drug Products

Private healthcare market in Romania Development forecasts for

Non-clinical development of biologics

Donau Kanol GmbH & Co KG Organization. Jänner Donau Chemie Gruppe

EXTRACTABLES AND LEACHABLES FOR MEDICAL DEVICES: MEETING THE 510 (k) REQUIREMENTS

Company Presentation

An Industry White Paper

MBA. Master. Market Access. Part-time berufsbegleitend. Pharmacovigilance. Strategic Management. Regulatory Affairs.

syriq Glass Prefillable Syringes

Note that the following document is copyright, details of which are provided on the next page.

Subject: Unit Dose PLUS Outsource Re-Packaging Service from Healthmark

QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES

ICH Q7 GMP for Active Pharmaceutical Ingredients

HANDLING OF RADIOACTIVE WASTES

motor consulting services Added value for motor insurers

Catalent Biologics & Clinical Supplies The SMART Solution

INMA LABORATORY MANUAL

C 5. chemical development contract research custom synthesis cgmp API manufacturing commercial production. Welcome to

New Trends In the Brazilian Healthcare Market. Rafael Vasconcellos,MD UHG

Cisco Data Center Services for OpenStack

Cosmetic & Personal Care Packaging

B. Braun Space GlucoseControl (SGC)

Improving Uptime in Aseptic Processing of Pharmaceutical Liquids with Blow-Fill-Seal

A Member of the Constructor Group STORAGE SOLUTIONS. Clever Thinking Inside the Box

Global regulatory affairs role in the biopharmaceutical industry

Humulin R (U500) insulin: Prescribing Guidance

CLINICAL DEVELOPMENT OPTIMIZATION

How To Run Afkem

Pivotal CRM 6.0. Benefit for your organization : a solution that can support your business needs

ICH Topic Q 1 A Stability Testing Guidelines: Stability Testing of New Drug Substances and Products

Evaluating Current Practices in Shelf Life Estimation

Medical Technologies. Helbling Technik Innovation, together we do it

HealthPro. Insurance products tailored for the healthcare industry. Your specialist commercial insurance partner across Europe

Overview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience

LABELMANAGEMENT WITH SAP - INTEGRATION

Biesterfeld Spezialchemie LifeScience Pharma. Product Portfolio Siliconisation / Adhesives / Silicone Elastomers. Vers. 3

INTRODUCTION. Viral shedding is crucial for Gene Therapy Products Safety linked with shedding data

Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry

A Primer: Solving the Unique Problems of Orphan Drug Communications Programs

Auvi-Q (epinephrine injection) 0.15mg and 0.3mg (Sanofi)

Triskel: a strategic consulting firm for biopharmaceutical companies

Package leaflet: Information for the patient. Naloxone Hydrochloride 20 micrograms / ml Solution for Injection Naloxone hydrochloride

Preparing a New Dermatologic Agent for Market Launch. March, 2011

Guidance on the content of a pharmacy manual to support clinical trial protocols

Continuous manufacturing moving towards real-time release. Creating innovations for the pharmaceutical industry. siemens.

Key considerations for outsourcing late phase clinical research

Pharma & Biotech processes: global turnkey solutions

How to implement a Quality Management System

Guidance for Industry. Q10 Pharmaceutical Quality System

Needs, Providing Solutions

Transcription:

Contract Manufacturing Connecting Competences. Realizing Ideas. Products, Project Management and Services for the Healthcare Industry

Sharing Expertise. System-built solutions As one of the leading companies in the healthcare market B. Braun stands for reliability and professionalism. No longer satisfied with products by themselves, our customers simply want more: involvement throughout every part of the process research, development, registration, production, packaging, distribution and application. Thanks to competences spanning our entire global corporate network, we make your vision a reality with system-built solutions. After all, when we share expertise we also share success. Enhanced efficiency, innovative products and sustainable services are just a consultation away.

Sharing Success. Pharmaceutical Contract Manufacturing Contract Manufacturing means production and filling of pharmaceuticals according to your specifications. Whatever option you choose, we fill solutions for irrigation, infusion therapy and volume replacement as well as standard injectables and anesthetics. We also fill dermatological products like creams, gels and pomades. Benefit from our in-depth knowledge in the production of drugs from aqueous solutions to lipid emulsions. With our technologies we will meet your challenges concerning processes and packaging. From bottle to body Take advantage of our expertise in the field of processes, solutions, containers, materials and compatibilities our technology meets your requirements. We are able to produce standard and custom solutions in small and large volumes. Depending on the requirements of your solution, we can offer the right container. The correct choice of material is made following stability and compatibility analysis. And it does not stop there our broad range of medical devices acts as a complement to the entire drug application system. Bags Vials Bottles Medical Devices Tubes Ampoules

Corporate Partners. Business partnerships that work Partnering with B. Braun gives you access to complete project management capabilities. From your first idea to the successful market launch, you can bank on us for the experienced input you need. Boost your success with our professional, system-built solutions. Analytical Services We will analyze the compatibility and stability of your solutions and drugs according to ICH upon agreement of a stability protocol. Galenic Development Support We will develop suitable galenic preparations in hydrous solutions and lipid emulsions including stability tests for your drugs. Pilot Batch Production Benefit from our support in product development. We back you up with clinical trials pilot batch as well as placebo batch production accompanied by our support of documentation. Private Labeling We are capable of producing your labels, imprints and wrappings, each tailored precisely to your specifications. Compatibility (ConComp) The ConComp database is a unique source of information for all your compatibility questions on drugs, container materials and IV solutions. Regulatory Support We will support you on a variety of regulatory issues providing technical documentation, product master files, safety sheets and certificates of analysis. Customer Service Our professional Customer Service team is always committed to providing the utmost care and attention in processing and managing your orders. Benefit from our central order processing and distribution services. We can deliver goods either to your warehouse or directly to your customer.

Sharing Success. Your benefits Instant access to our company s knowledge of healthcare, markets, processes, technologies and products Improved efficiency resulting from time and cost savings Enhanced product portfolios Shorter times-to-market Lower investment in development and research Access to emerging international markets Contract Manufacturing

Containers at a Glance. Ecoflac plus 100 ml, 250 ml, 500 ml, 1000 ml Glass bottles 100 ml, 250 ml, 500 ml, 1000 ml Vials 2 ml, 5 ml, 10 ml, 20 ml, 50 ml, 100 ml Ecotainer 250 ml, 500 ml, 1000 ml Ecolav 30 ml, 100 ml, 250 ml, 500 ml, 1000 ml Mini-Plasco 5 ml, 10 ml, 20 ml Glass ampoules 1 ml, 2 ml, 3 ml, 5 ml, 10 ml, 20 ml Tubes 2 g - 200 g Bags Ampoules Tubes Bottles Ecobag 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml, 3000 ml, 5000 ml Nutriflex 2 Chamber 1000 ml, 1500 ml, 2000 ml NuTRIflex 3 Chamber 1250 ml, 1875 ml, 2500 ml B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany Tel +49(0) 5661 71-2826 Fax +49(0) 5661 71-3562 W. 02.09.06/2 info-europe@bbraunoem.com www.bbraun.com www.bbraunoem.com