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Accelerator Development Services
Providing targeted development and consultation
services customized to the needs of your project
On-Site Technical Support
Consultation Services to Speed Development
Comprehensive Cell Culture Process Development
Instrument Installation and Qualification
Customized Training Programs
Comprehensive Process Support
Pall Life Sciences is a leading provider of bioprocess solutions.
Our innovative single-use technologies are designed to maximize
product quality, optimize manufacturing costs and support bioprocess development. To ensure success, all of our products
are supported globally by an experienced team of scientists and
engineers. From on-site guidance to larger projects in our own
process development laboratories, we can help take your
process to the next level.
Bioprocess Consulting Services
Skilled cell culture scientists are available both remotely and
on-site to assist with process development and optimization.
Our broad exposure and experience can help identify critical
areas for process improvement.
Process Development Services
Innovative technologies, modern laboratories, and experienced
scientists combine to help take your process to the next level.
Our comprehensive services smooth the learning curve, allowing
adoption of advanced methods despite tight timelines.
Qualification Services
Our cell culture technologies are supported on site with
thorough services which simplify cGMP compliance.
Standard services such as installation, IQ/OQ and training
are complemented by custom services to meet the specific
needs of every process.
Streamlining Process Improvement
Speed-to-clinic and speed-to-market are often the primary
drivers of research timelines. Our customers tell us that suboptimal processes which can be quickly developed are often
commercialized, creating long term burdens to supporting future
campaigns. Opportunities to modernize and shape future projects
are lost when researchers are driven by timeline to develop
processes using dated methods. Pall Process Development
services remove the burden of learning curve and provides a
streamlined path to the most modern bioreactors and methods
available in the market.
2
The Effect of Experience
Learning curve and the related experience curve are well
studied phenomena which describe the large impact a lack
of familiarity can have on overall productivity, quality and
speed. Even experienced scientists can feel the impact of these
effects when presented with new technologies or methods. The
unknown time required to summit these curves can discourage
innovative approaches during a typical process development.
In addition, incorporating a learning curve into a project plan
reduces resources available for optimization and other necessary
tasks. Pall Process Development Services can demystify the
adoption of new technologies. Our clear timelines, targeted
expertise and process transfer support allow clients to meet
aggressive timelines successfully.
Novel Technologies to Support Diverse
Applications
Experience matters when timelines are tight. Accelerator scientists
have the skills and exposure to bring the latest methods to your
process. Clients benefit from this experience through timeline
reduction, process efficiency, compliance and future-readiness.
With unique bioreactors designed to support both large and
underserved cell culture markets, we have solutions for numerous
applications.
Targeted Experts for Accelerated Timelines
An extra hand or access to expert advice during crucial times
can be the difference between meeting project goals and
delivering late. Partnering with our team of experts provides
extra support when it is needed most.
Global Applications Support
Process development and optimization
Product lifecycle support
Global support and service
Pre-System/Product Delivery Service
Key Focus Areas
Stem Cell Production
Stem Cells (Adipose Derived, Bone Marrow, Hepatic
Progenitor), Cardiac Lineage Committed Cells
Case Study: Transfer of hepatic progenitor process from
flatware to the Xpansion® multiplate bioreactor in 8 months
Case Study: Transfer of adherent stem cell processes from
flatware to microcarrier-based culture in stirred tank
bioreactors
Protein Production
Optimization and scale-up of CHO and baculovirus
expression systems
Trial support
Customization support
Process feasibility studies
Factory Acceptance Test (FAT)
Installation Support Services
Site Acceptance Test (SAT)
Installation Qualification (IQ)
Operational Qualification (OQ)
Startup assistance and training
Process Optimization
Multiple suspended and adherent cell lines supported
Mixing and cell culture studies
Case Study: A QbD approach for the implementation
of a PadReactor® single-use bioreactor
Technology transfer
Viral Vaccine and Viral Vector Production
Supporting both human and animal health
Viruses (flu, polio, rabies, herpes, BHV etc.) and viral vectors
(adenovirus, AAV, etc)
Yield enhancement
Process scale-up/scale-down
Equipment Maintenance
Warranty and extended warranty
A549, HEK293, MDBK, Vero, MDCK, MRC5, BHK21, CEF,
SF9 cells, etc.
Service and maintenance agreements
Case Study: linear scalability of virus production in iCELLis®
fixed bed bioreactor in less than nine months.
Calibration, repairs and troubleshooting
Preventative maintenance
Case Study: Microcarrier-based Dengue virus expression
in Animal component-free media
Microcarrier-based influenza production
Whole-cell, microcarrier-based production of Marek’s vaccine
www.pall.com
3
Worldwide Support
Customized Service Proposals
Our laboratories are fully equipped with the most current Pall
single-use technologies for upstream and downstream processes.
Skilled Applications Scientists are available for on-site support
in the Americas from our North American facilities and throughout Europe and Asia from our European facilities.
We know that every project is different and there are no
standard research problems. Our team carefully evaluates
project requirements and develops customized approaches
for every proposal. Our five-step process focuses on
communication and understanding to ensure success.
DISCUSSION
Our team is trained to listen. We take the time
to collect background knowledge and ensure
complete understanding of research objectives.
DEFINITION
Each project begins with a translation of
existing data and research goals into a detailed
proposal which defines our planned approach.
Westborough, MA, United States
307 m2 of configurable laboratory space
Class 10,000 cleanrooms and BL2-grade suites
Newly designed laboratories with a focus on recombinant
protein and cell therapy processes
Ann Arbor, MI, United States
400 m2 of laboratory space
APPLICATION
Three rooms for BL-2 support and one BL-2+area
Focus on adherent microcarrier processes with training
facilities for small groups to learn techniques for microcarrier
process development
Brussels, Belgium
OPTIMIZATION
EDUCATION
At launch, projects are assigned project and
technical management. Then research begins
in our laboratories or at the customer site.
Experiments build on the last to quickly move
to an optimized process. Milestones conclude
with collaborative evaluation to plan next steps.
To ensure success, our scientists support
transfer of the optimized process through
on-site support, training and documentation.
2
360 m of laboratory space
Five BL-2 rooms with the capability to convert to BL-3
as projects require
Focus on cell therapy and viral processes
Portsmouth, United Kingdom
337 m2 of configurable BL2-grade suites
Newly designed laboratories with a focus on innovative
methods for recombinant protein and adherent cell culture
processes
Advanced analytics on site including QTOF, H-Class Bio
UPLC and ForteBio Octet® systems
Visit us on the Web at www.pall.com/biopharm
E-mail us at bioreactors@pall.com
Corporate Headquarters
Port Washington, NY, USA
+1.800.717.7255 toll free (USA)
+1.516.484.5400 phone
biopharm@pall.com e-mail
European Headquarters
Fribourg, Switzerland
+41 (0)26 350 53 00 phone
LifeSciences.EU@pall.com e-mail
Asia-Pacific Headquarters
Singapore
+65 6389 6500 phone
sgcustomerservice@pall.com e-mail
International Offices
Pall Corporation has offices and plants throughout the world in: Argentina, Australia, Austria, Belgium, Brazil,
Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, New Zealand, Norway,
Philippines, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United
Kingdom, and Vietnam. Distributors in all major industrial areas of the world. To locate the Pall office or distributor
nearest you, visit www.pall.com/contact.
The information provided in this literature was reviewed for accuracy at the time of publication. Product data
may be subject to change without notice. For current information consult your local Pall distributor or contact
Pall directly.
© 2015, Pall Corporation. Pall,
, Fortebio, iCELLis, Octet, PadReactor and Xpansion are trademarks of
Pall Corporation. ® indicates a trademark registered in the USA. Filtration.Separation.Solution. is a service
mark of Pall Corporation.
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