global contract manufacturing excellence - bioxcellence · · 2016-06-22global contract...
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Boehringer Ingelheim BioXcellence™
Global Contract Manufacturing Excellence
Producing Value
Boehringer Ingelheim BioXcellence™
Your World Class Contract Manufacturer
Producing Value
Boehringer Ingelheim BioXcellence™ is a leading contract manufacturer with more than 35 years of experience – more than 25 biopharmaceutical products brought to market.
Boehringer Ingelheim BioXcellence™
• We provide tailor-made solutions – where you need us, when you need us
• Our transparent, modular approach -regardless of your project’s stage, scope or scales- makes outsourcing easy
• Our experience, reliability and flexibility help you to better focus on your strategic priorities
• As a family-owned business, we pride ourselves on stability and committed long-term relationships
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Our Mission: Producing Value
Boehringer Ingelheim BioXcellence™
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Boehringer Ingelheim has a long history
in the field of biotechnology, having been in
the industry for more than 35 years and in
contract manufacturing since 1995. During
that time we have helped our customers to
bring more than 25 molecules to the market.
This has earned us a reputation as one of the
most experienced and reliable contract manu-
facturing organizations (CMO) in the world.
Boehringer Ingelheim Contract Manufacturing
has now evolved into Boehringer Ingelheim
BioXcellence™ - your dedicated contract
manufacturer.
Boehringer Ingelheim BioXcellence™ provides
the entire production technology chain
from DNA to fill and finish at our facilities
in Biberach (Germany), Vienna (Austria),
Fremont (USA) and Shanghai (China).
We have a total commercial capacity of up
to 300,000 liters with flexible scales between
400 and 15,000 liters. For products derived
from microbial fermentation technology more
than 12,000 liters of commercial capacity with
flexible scales from 200 liters to 6,000 liters
are installed at our site in Vienna, Austria.
With more than 2,800 employees
in biopharma development, quality and manu-
facturing Boehringer Ingelheim BioXcellence™
is your sustainable, committed contract
development and manufacturing partner -
producing value for you.
We provide smart manufacturing solutions to the industry, empowering our customers to successfully navigate the challenges of the biopharmaceutical market.
Producing Value
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Where you need us, when you need usAll of the elements required for outsourcing biopharmaceutical
development and manufacture, from high expression systems to fill
and finish, including patient convenient application systems, can be
found within the service offering of Boehringer Ingelheim BioXcellence™.
We offer our customers an integrated, seamless approach to reliable
and efficient outsourcing.
This includes process development, cell culture technologies, microbial
technologies, upstream technologies, downstream technologies, tech
transfer and scale up, process validation, pharmaceutical development,
analytical labs, CMC documentation support, formulation, fill and finish,
packaging, shipping validation and much more.
Whether you are looking for contract development and manufacturing
of individual work packages only or for a partner for the entire product life
cycle – we are looking forward to talking to you. Where you need us –
when you need us.
Boehringer Ingelheim BioXcellence™
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Experience Boehringer Ingelheim Quality
At Boehringer Ingelheim BioXcellence™ we are
well aware of the responsibility that comes
with contract manufacturing – producing
reliable biopharmaceutical products for
patients.
To this end, our production plants operate
under cGMP and are approved as such. We
not only meet the highest level of compliance,
but strive to exceed it, both through regular
internal audits and by asking external consul-
tants to give us an outside perspective. Last
and most important, we value the input of
our partners through their regular audits and
leverage these opportunities to continually
improve our processes.
Producing Value
The track record of our multi-product facili-
ties include inspections by the Food and Drug
Administration (FDA), the European Medicines
Agency (EMA), Health Canada, MHLW, SFDA,
and many other authorities.
Our Biopharmaceuticals Production Sites
Fremont, California, USAVienna, Austria
Shanghai, China
Biberach, Germany
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Boehringer Ingelheim BioXcellence™
Get your Product to Market faster
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Producing Value
Finding the optimal strategy together
It is our ambition to maintain our position as one of the
industry’s most trusted manufacturing partners.
As your partner, we offer you the opportunity to leverage
our expertise and process excellence at any stage of the
development and production process. Our transparent
and modular approach guarantees you complete project
flexibility while maintaining full control over the process.
Together with you, we will be happy to identify the project
design that is most suitable for your strategic objectives
and then implement it — while ensuring maximum
efficiency, safety, quality and cost effectiveness.
Lean-to-Clinic
Reaching investigational new drug application (IND)
is a critical milestone for most companies. Boehringer
Ingelheim BioXcellence™ has established a ‘Lean-to-Clinic’
program for monoclonal antibodies which consists of
streamlined work packages based on platform technologies
and standardized processes. It significantly speeds up
cell line development, Phase I process development and
preclinical and clinical supplies.
Smart-to-Launch
Our Smart-to-Launch approach ensures fast track project
transfer to commercial scale. We transfer your project
into our facilities and deliver clinical phase III material,
commercial product or early second source supply focused
on extremely short timelines.
Tailored Transfer
We provide established and proven transfer procedures to
enable seamless, reliable second source- and legacy product
supply. Our well experienced transfer teams develop together
with you a tailored transfer scenario. In a ‘one team ap-
proach’ all necessary work packages for facility adaptation,
production transfer and installation of product specific ana-
lytical quality methods are identified and executed focused
on product- and process comparability.
Pharmaceutical Development
Boehringer Ingelheim BioXcellence™ offers pharmaceutical
development of biopharmaceuticals, applying state-of-
the-art technologies for sophisticated pre-formulation,
formulation and pharmaceutical process development.
The dosage form portfolio ranges from solutions, highly
concentrated liquid formulations, suspensions, lyophilized
or spray-dried powders to inhalable presentations
combined with state-of-the-art proprietary application
systems.
Fill and Finish
We provide the entire drug product manufacturing chain
comprising filling, lyophilization and visual inspection.
Within our global manufacturing network we can supply
different dosage forms such as liquid or lyophilized
preparations in vials and technically more complex
dosage forms such as prefilled syringes and dual-chamber
cartridges.
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Local Business Development and Key Account
Management – globally
Boehringer Ingelheim BioXcellence™ has
established Business Development and Key
Account Management (BD & KAM) teams in
the major markets (Americas, Europe and
Asia-Pacific). Our local expert representatives
are the first point of contact for our customers.
They take care of our customers and their
projects from early information exchange to
the end of the project, and ensure smooth
transfer to our project management at our
facilities in Germany, Austria, USA or China.
Your Product. Our Passion.
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Boehringer Ingelheim BioXcellence™welcomes your enquiries, questions and feedback.
Contact [email protected]
Contact [email protected]
Contact Asia/[email protected]
Producing Value
Copyright
© Boehringer Ingelheim Biopharmaceuticals GmbH, November 2015. All rights
reserved. No part of this brochure may be reproduced or transmitted in any form
or by any means, electronic or photocopy, without permission in writing from
Boehringer Ingelheim Biopharmaceuticals GmbH.
December 2015
www.bioxcellence.com