A solution-driven partnership focused on solving real

Solution-driven innovation for biomanufacturing
A solution-driven partnership
focused on solving real challenges for our clients
Putting it all together
SAFC and SSB have you covered for all your biomanufacturing
needs including media development and manufacturing,
downstream raw materials, packaging, single-use mixing,
sterile filtration, storage and transportation of liquids.
A Profile of SAFC
SAFC is a leading developer and
manufacturer of critical raw materials and services that support the
biopharmaceutical industry. Using
unrivaled expertise, SAFC’s scientists
identify and anticipate customer
requirements and work to resolve
the bioprocessing obstacles that can
occur at every stage – from preclinical to commercialization. SAFC is
known for safe, productive and consistent raw materials and services,
providing customers with a greater
feeling of confidence and control.
The SAFC portfolio includes proficiency in developing and manufacturing upstream and downstream
solutions, single-use packaging and
scale up services. It offers the widest
selection of liquid media available to
the market, encompassing custom
media, supplements | feeds, buffers,
water and reagents. SAFC’s extensive
liquid offerings are produced in
state-of-the-art Centers of Excellence facilities that are cGMP compliant and employ fully validated processes. The Centers of Excellence act
as an extension of a customers’
organization, designed to operationally deliver continuity of supply, consistency in raw material and process
control and industry leading quality.
Currently comprised of the company’s Broadway (St. Louis, Missouri),
Lenexa, (Kansas) and Irvine (UK)
facilities, these Centers address
industry demands for efficiency,
cost containment and increased
regulatory compliance.
With locations across the globe, SAFC
is able to serve customer needs at
source and without limitation. The
global footprint of SAFC’s facilities
offers customers supply chain
security and mitigation of process
delay risk through tailored solutions,
ready-to-use formats, and on-time
delivery.
A Profile of
Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading
provider of cutting-edge equipment
and services for the development,
quality assurance and production
processes of the biopharmaceutical
industry. Its inte-grated solutions
covering fermentation, filtration,
purification, fluid management and
lab technologies are supporting the
biopharmaceutical industry around
the world to develop and produce
drugs safely, timely and economically. Sartorius Stedim Biotech focuses
on single-use technologies and value-added services to meet the rapidly
changing technology requirements
of the industry it serves. Strongly
rooted in the scientific community
and closely allied with customers and
technology partners, the company
is dedicated to its philosophy of
‘turning science into solutions’.
Headquartered in Aubagne, France,
Sartorius Stedim Biotech is listed on
the Eurolist of Euronext Paris. With
its own manufacturing and R&D sites
in Europe, North America and Asia
and a global network of sales companies, Sartorius Stedim Biotech enjoys
a worldwide presence. Its key manufacturing and R&D site is in Germany.
Single-Use Solutions
are enabling liquid outsourcing
Increasingly, biopharmaceutical
manufacturers are looking towards
outsourced single-use liquid packaging solutions for their processes in
order to realize resource benefits
such as avoiding the infrastructure
and time needed to prepare liquid
reagents.
Now, SAFC, a global leader in bioproduction raw materials for upstream
and downstream processes, and SSB,
a world-class supplier of single-use
fluid management, cell culture,
purification, filtration and process
monitoring technologies and services,
have come together to create an
industry leading alliance in liquid
solutions.
The partnership offers:
– Unmatched product portfolio
and expertise on all aspects of
single-use packaging and liquid
raw materials
– Lower resource requirements
as customers can rely on
pre-done application data
to support validation needs
– Extensive technical support
– Service coverage to support the
customer from cell line development through to downstream
process development and all steps
in between for lower costs and
lower development time
Technology scale up, application development, process design and validation services
Product and
service examples
ZFNs, CHOZN
Development
Preclinical
Phase I
Phase II
Phase III
Cell line development
Custom media development, IA, Quickscale
Media development and scale-up
Process development
Ongoing support services
Single-Use & multi-use process technology integration and services
Product examples
Media
preparation
Bioreactor
Ex-Cell CHO Fusion, EB66
Media
Ex-Cell Antifoam, CD
Hydrolysate
Supplements, feeds and
growth factores
Cell harvest
Buffer
preparation
Purification
HEPES, TRIS
Biological buffers
NaOH, Sucrose
Purification buffers and reagents
You need a partner who has deep control over their
supply chain with multiple sources and disaster
control protocols in place – a partner who also has
the experience to help you install multiple layers
of control to your processes to minimize risk.
Commercial
Launch
Understanding your needs
lets us turn science into solutions
Commitment to Continuity
of Supply and Quality
Any problems with raw materials or
in-process products can lead to lost
revenue from delays in development
and manufacturing or even product
recalls. Therefore you need to insure
not only that your supply of raw
materials is uninterrupted but also
it is of the highest possible quality.
SAFC and SSB each have decades
of experience at reliably providing
products that are consistently of
the highest quality.
We manage supply
continuity through
– Supplier Qualification and
Management Program
– Long-term supply agreements
with key suppliers
– Dual validation & sourcing
of critical RM
– Multi site production for
component suppliers and finished
single-use products
– Vertical integration for critical
components
– Robust change control process
– Pre-done validation work relating
to changes
– Maintenance of safety stock
Quality by Design and
Risk Management
We quantify risk in order to prioritize
it. We identify factors that could
impact delivery or quality and then
develop a risk mitigation plan such
as secondary sourcing, maintaining
a safety stock, and insuring that the
supplier has excellent quality
controls in place.
In our manufacturing processes we
are dedicated to minimizing the
risk of contamination by providing
multiple layers of security including
removing animal origin raw materials
from our processes where possible
and vigorous treatment of agricultural | commodity origin raw
materials where not.
Our expertise in qualifying singleuse components provides quality
by design and robust solutions with
proven functionalities. Single-use
custom products are built from multiple components assembled together
to meet the pre defined functional
specifications.
We control your risk by
– Robust internal quality systems
including CAPA and OOS control
– Industry leading compliance:
ICH Guideline Q8, Q9 and Q10;
Orange Guide-Annex 1 adherence
– Controlling process risk by working
directly with you on application
support and training
– Dedicated ACF production
– Disaster recovery plan
“Robust, predictable
solutions every step
of the way”
Efficiency enhancement
for cost and resource benefits
Operational Support
Resources are limited and it is
important to find ways to do more
with less. The primary approach has
been to improve productivity while
looking to streamline and optimize
operations.
The biomanufacturing industry is
investing heavily in new technologies, training, and facility improvements, and is turning to outsourcing
partners as a way to control costs
using external resources as
an extension of their own so that
the internally focus is only on critical
value-added activities.
When considering your options for
developing a new process or the
improvement of an existing one,
you don’t have to start from scratch.
We’ve organized our commercial and
technical teams and our manufacturing facilities to be an extension of
your operations, providing product
and process improvement through
specialized teams so that you can
enjoy shorter development times,
lower resource requirements and
ultimately lower costs.
We support your operations by
– Custom media & feed development
– Concentrate and complex formulation development and support
– Joint SAFC | SSB coordinated technical teams
– Analytical testing
– Chemical compatibility testing
– Site Acceptance Tests (SAT)
– Operator training
Products and Validation
Our expertise allows us to recommend optimal solutions on raw materials and packaging so that you order
just the right amount of material
and use packaging designs that have
just the connections and fittings
that make sense for your process to
reduce cost and waste.
We have performed extensive studies
on the combination of SAFC liquid
products in SAFC packaging including mixing, filterability, extractables | leachables and shipping. You
can leverage these data packages
to aid in the design of your processes and to validate your protocols,
thereby saving time and effort.
We support your validation
needs by
– Joint SAFC | SSB application-based
data packages including extractable | leachable testing
– Joint SAFC | SSB coordinated
commercial and technical teams
– Filter validation testing
– Mixing protocol development
– IQOQ of instruments and hardware
“The right products
and the right support”
You need a partner with the cell culture experience
to guide and support your efforts – a partner that
can provide operational support to find the right
product and process solutions to fit your needs and
minimize costs without generating waste.
Increasing speed and flexibility
Flexibility to Meet Your Needs
We understand that there are constant pressures to speed processing
and to reduce the time to market.
In this environment, single-use technologies have become an important
part of a wide range of biopharmaceutical applications.
Standardized, turnkey solutions and
unit operation platforms can help
speed process development and production through the use of pre-done
validation packages and fast delivery
of orders.
At other times, however, you need
to address a unique aspect of your
process, and so customized solutions
such as pre-mixed formulations
packaged in an optimal volume
are required.
Standardization
Biopharmaceutical companies need
to get to market quickly and for that
you need fast and flexible process
development solutions. SSB and SAFC
offer a wide range of standard products to help you get moving from
initial development through scale-up
and to manufacturing including
media, buffer and packaging.
We offer choice in standardized
products
– imMEDIAte ADVANTAGE packaging
– Flexboy® bags from 1 L to 20 L
– Flexel® bags from 1 L to 20 L
– QUICKSCALE packaging
– Flexboy® bags from 10 L to 20 L
– Flexel® bags from 10 L to 200 L
– EX-CELL media library
– A wide selection of supplements,
feeds, buffers and other reagents
Customized Solutions
Every process is different. Although
standardization is a great place to
start, formulation may require custom solutions, and we stand ready
to find the right answer for your
process. We provide customer led
innovation, as by working side by side
we can create innovative solutions
just right for you.
We are ready to work with you
– Media, feed, and concentrate
development
– Downstream buffer development
– Cell line development
– Process development support
– Custom liquid packaging solutions
Responsiveness
You may be looking to quickly determine the best media formulation for
a cell line, or you may need to scaleup rapidly so that you can move on
to the next stage of development. Or
you may simply be facing unforeseen
demand and you need a vendor who
can respond quickly. SAFC and SSB
are ready help.
We’ll be there when you need us
SAFC
– Manufacturing in the US and
Europe for global responsiveness
– Over 80 scientists, engineers,
project managers and technical
service scientists
SSB
– Global manufacturing
– Over 200 application specialists,
project managers,validation
scientists and service technicians
You need a partner who has a broad range of standardized raw materials
and packaging available for upstream and downstream applications, but
is able to work with you to design and develop custom solutions when
standardized ones are not available – a responsive partner who has the
support infrastructure and solutions in place to accelerate your process.
“Easing the path to market
through process development
and nimble manufacturing”
SAFC & SSB global facilities
For more information on the partnership and a full list of our worldwide offices,
please visit www.sartorius-stedim.com/safc.
United Kingdom
Irvine
Germany
Göttingen
France
Aubagne
SSB Facilities
Göttingen
August-Spindler-Strasse 11, 37079 Goettingen
Phone +49.551.308.0 | Fax +49.551.308.3289
Aubagne
ZI Les Paluds, Avenue de Jouques – BP 1051
13781 Aubagne Cedex
Phone +33.442.845600 | Fax +33.442.845619
Concord
1910 Mark Court, Concord, CA 94520
Toll Free +1.800.914.6644 | Fax +1.925.689.6988
New York
5 Orville Drive, Bohemia, NY 11716
Toll-Free +1.800.368.7178 | Fax +1.631.254.4253
SAFC Facilities
Lenexa
13804 W. 107th Street, Lenexa, KS 66215
Phone +1.800.255.6032 | Fax +1.913.469.5584 | [email protected]
St. Louis
3506 South Broadway, St. Louis, MO 63118 USA
Phone +1.800.244.1173 | Fax +1.314.286.8036
Irvine
Second Avenue, Heatherhouse Industrial Estate, KA12 8NB,
Irvine, Scotland, United Kingdom
Phone +44.1264.333311 | Fax +44.1264.332412 | [email protected]
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USA
St. Louis
Lenexa
New York
Concord