Drug Discovery/ Development & Delivery
Reduce Costs and Gain Expertise by Outsourcing
your Cell Culture and Cryostorage
Cell culture has evolved over more
than a century into a core technique
that is central to a diverse range of
research and clinical applications.
These range from the study of basic
biological processes through to stem
cell therapy and tissue engineering.
As well as contributing to ethical
progress by helping to reduce the
use of animals, cell culture provides
a number of key scientific benefits.
In pharmaceutical research and
development, cell culture has an
increasing number of cutting-edge
roles, including a contribution to
reduced attrition rates by allowing
sophisticated early-stage safety and
efficacy screening. Scientists are able
to rapidly assess the potential efficacy
of large numbers of compounds in
high throughput screening (HTS)
assays, as well as using the technique
for target validation and to investigate
issues arising in toxicology and ADME.
In addition to these established
applications in an R&D setting, cells
now play an increasingly dominant role
in the biomanufacture of therapeutics
– the fastest growing area of the cell
culture industry. In parallel with these
developments,
establishing
and
maintaining optimal systems for the
culture, cryopreservation and storage
of a wide variety of cell types has now
become a priority.
The Challenges of Cryostorage
Cryopreservation is essential to
maintain a long-term, consistent
supply of precious cultures. In the
absence of good cell banking practices
and cryopreservation procedures, the
continuous culture of cell lines leads to
an array of problems including genetic
drift, loss of key characteristics and
an increased probability of microbial
contamination.
Such
a
significant
role
in
biopharmaceutical R&D creates a
need for specialist expertise in a wide
variety of cell culture technologies.
Screening applications utilise both
normal and diseased cell lines from
humans as well as key toxicology
species. Increasingly, there is a need
for primary cells in order to address
specific disease mechanisms. Primary
cells are those that have not undergone
an immortalisation process. They
therefore generally reflect the in vivo
situation more effectively than an
immortalised cell line, but as they only
have a finite lifespan, expanding the
culture to provide sufficient cells for
an HTS assay often requires specialist
expertise. Every cell type requires an
optimised system of culture medium
and reagents, and needs some
validation prior to use. In many cases,
safety assessment departments face
constantly changing requirements in
the cell types that need to be cultured,
as in vivo toxicology studies can raise
issues and questions that need to be
examined more closely in vitro, using
a specific cell type in one or more
species. Some studies require the
use of specialised 3D human tissue
models, which require significant
operator training. This constantly
changing landscape inevitably brings
corresponding challenges in terms of
maintaining in-house expertise within
budgetary restrictions.
As the pharmaceutical industry
undergoes major structural changes,
with mergers, acquisitions and site
consolidations now regular features,
the demands of keeping up with
constantly changing requirements
can become increasingly complex.
Key team members may be lost or
face significant downtime during
relocation and/or the merging of
company cultures. Maintaining key
operational cell culture activities and
the secure storage of cell banks is a
critical requirement during this time.
Advantages
of
Outsourcing
Support Services
Outsourcing selected activities can
significantly ease the pressure and
a good outsourcing laboratory will
work alongside you as a partner,
supporting both current and upcoming
needs, allowing you to dip in and out
of additional support as and when
required. You may choose to use an
outsourced cell culture laboratory
occasionally to enhance existing inhouse expertise when an unusual
short-term requirement arises. Or
you might go for a more substantial
44 INTERNATIONAL PHARMACEUTICAL INDUSTRY
Summer 2012 Volume 4 Issue 3
Drug Discovery/ Development & Delivery
outsourcing option. Key services
include the expansion of cells into
master and working cell banks, cell
line characterisation, genetic profiling,
mycoplasma and sterility testing.
When required, the cells can be
thawed and grown in the outsourced
lab and provided to your team in any
format as assay-ready cells, or assays
can be carried out for you. If you only
have a one-off or short-term need for
a cell type, rather than optimising the
culture methods in-house, consider
asking your outsourced lab to expand
the cells for you and provide them
in a no-fuss, assay-ready format.
There is a good chance they will have
prior experience with the cell type
in question – and utilising existing
expertise could lead to beneficial
savings in both time and cost.
Choosing the Right Partner
The flexible array of outsourcing
choices opens up a whole new
approach to cell culture, changing
and growing alongside your evolving
business. However, the right choice of
partner is critical. A good outsourced
laboratory should be willing to invest
the time to listen to and support your
needs to at least the same standard
and thoroughness that you would
expect from your own in-house
scientists.
Trust,
approachability
and flexibility are all preferable to
a rigid structure that does not lend
itself to reacting quickly to changing
requirements. The presence of the
right equipment, volume capacity,
turnaround time, quality systems and
data security are all crucial factors
when selecting your potential partner.
You may choose to work with multiple
laboratories to gain the best access to
specialist expertise. XCellR8 (www.xcellr8.com) is a company that aims
to maximise the productivity of cell
culture-based research by providing
easy access to specialist services.
They adopt a unique approach by
combining an outsourcing facility
for cell banking services and in vitro
contract testing with training events
and technical support. In effect, the
UK-based company in Manchester will
either take on your cell culture work
for you, or help to empower your own
team through training and technical
support. XCellR8’s philosophy is to
46 INTERNATIONAL PHARMACEUTICAL INDUSTRY
share its expertise and maximise the
benefits, so support is available at
whatever occasional level is required
even if your day-to-day policy is not to
outsource. The company believes that
in doing so it is fulfilling a previously
unmet need for the biopharmaceutical
industry. In today’s climate, flexibility
is key, and you need to be able to
choose whatever level of external
support is best for you and your
team.
Outsourcing Cryogenic Storage
Successful outsourcing of controlled
environment storage provides access
to state-of-the-art facilities while
enabling significant cost reduction
due to economy of scale at the
outsourced facility. In addition, it can
provide peace of mind, whether the
goal is long-term storage or an interim
solution. During site consolidations
following a merger or acquisition for
instance, outsourced storage could
be the ideal solution. However, if
handled badly, any type of business
process outsourcing can unsettle your
organisation, resulting in lower quality
of services. The right outsourced
storage organisation will seek to
build effective partnerships and
respond quickly to specific market
requirements, giving guidance on
critical aspects including laboratory
processing and liaison with regulatory
bodies. Choosing a partner that
understands your market sector, and
the pressures that are exerted on it,
will ensure a more efficient process to
help motivate your own plans for the
future.
In drug development, cost control
is a critical component of maintaining
a competitive advantage. If you
want to free up aspects of your own
operations that might not be running
efficiently, it may be worth considering
the merits of outsourcing some of
your more routine services. Cryogenic
storage will allow your team to focus
on core competencies while enabling
instant access to state-of-the-art,
secure facilities without the need
for capital outlay, additional space,
equipment maintenance or additional
training and labour costs.
When choosing your preferred
outsourcing
partner
(POP)
for
cryogenic storage, you should
question
whether
the
selected
company has the following attributes:
• A proven track record.
• State-of-the-art facilities.
• Computer-controlled guarantees for
temperature integrity, with constant
monitoring.
• Full emergency backup, including
spare equipment.
• Dedicated service teams on call
24/7/365.
• High-security environment, including
access control systems, motion
detectors, smoke detectors and
continual CCTV surveillance.
• Reliable sample tracking.
• Simple but secure access to
your sample information and a
straightforward process for sample
retrieval when required.
• A
fully
documented
disaster
recovery plan.
• Affordability.
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Drug Discovery/ Development & Delivery
•T
he financial capability to match the
continued investment needed for
your requirements and assurance
that long-term requirements will be
met.
If the answers to all of these questions
are affirmative, you’ve found your
perfect POP. The chosen company
must also have a comprehensive
quality assurance programme with
best practice standard operating
procedures, as well as systems in
place to demonstrate the use of
regular internal audits for compliance
with appropriate regulatory bodies.
The company should be able to
provide security, absolute visibility of
process, and reliable access to the
materials using current compliant
procedures.
A
comprehensive
information
management system is at the heart
of all storage solutions. The inventory
management solution should enable
the user to record all data associated
with the samples, including location
and temperature, as well as recording
all user-defined information. Every
sample handled must be given
a unique barcode label and then
recorded on the compliant database
system.
This
significantly
simplifies
handling, tracking and processing.
Supplementary information relating
to individual samples in terms of
movement within the facility, time
and duration of storage vessel
openings and who accessed the
vessel must also be available as
part of a comprehensive audit trail.
All staff should be fully accountable
and provide a service that complies
with regulatory requirements. Cells
destined for biomanufacturing and
therapeutic applications must be
handled at all times according to
cGMP guidelines. Clearly the cGMP
service provided by your POP should
always meet legislative obligations.
Effective Disaster Backup
Commercial
organisations
are
increasingly looking at their approach
to
disaster
recovery.
Backup
secondary storage is considered to be
an effective insurance policy against
the various mishaps that are beyond
your control and is an alternative to
48 INTERNATIONAL PHARMACEUTICAL INDUSTRY
total outsourcing. With this model,
in parallel with the primary in-house
storage facility, a set of duplicate
samples is retained by a third party,
in a secure second geographical
location. The purpose of any disaster
recovery plan would include the
following benefits:
• Minimise potential economic loss.
• Insure against the loss of products
in storage.
• Counteract the disruption to stability
storage activities.
• Reduce critical loss to your
company.
• Provide an orderly recovery of
product.
This
approach
is
well
worth
considering on the basis that it virtually
eliminates the risk of a disaster
scenario destroying a company’s
valuable stability storage samples
and causing commercial damage to
the organisation.
The use of outsourcing for
the cryogenic storage of cells is
becoming increasingly popular in
the
biopharmaceutical
industry.
Vindon
Scientific
(www.vindon.
co.uk), based in the UK near
Rochdale, has significant experience
in controlled temperature storage for
the pharmaceutical industry, and its
state-of-the-art CryoBank provides
companies with access to premium
facilities and specialist expertise,
while helping to reduce their costs.
Some organisations still prefer total
control of their own storage. However,
depending on the company strategy,
it can make more sense to outsource
cryogenic storage to an experienced
entity based elsewhere. Quite clearly,
this kind of move needs careful
thought in terms of price, quality of
service and flexibility of approach.
Conclusion
As the pharmaceutical industry
undergoes major changes, this could
be the ideal time to reassess your
current facilities and to carry out a
cost-benefit analysis of outsourcing
cell culture services and / or cryogenic
cell storage for your organisation.
Outsourcing isn’t right for everyone
but it is well worth consideration,
bearing in mind that you can pick and
choose exactly which activities make
sense for you to outsource. There
may be opportunities to reduce costs
and avoid significant project delays
through rapid access to specialist
expertise.
Outsourcing can be strategic, costeffective, efficient and productive –
all of which are tempting incentives.
When handled competently, the results
are well worth the initial effort and can
add a valuable new dimension to your
biopharmaceutical R&D.
Patrick Jackson
Patrick Jackson
is
Business
Development
Director, Vindon
Scientific
Limited, he is a qualified engineer,
with over 35 years’ experience in
senior management and business
development
and
marketing.
Patrick has held a number of Board
appointments as; Sales Director,
Commercial Director, Operations
Director and Business Development
Director for a diverse range of
companies, he has a successful
record of developing business
systems to sustain growth in highly
competitive markets focussing on
formulating working relationships with
clients and major sub-contractors
and negotiating exclusive trading
agreements by developing a client
and supplier partnership philosophy.
Email: [email protected]
Dr Carol Barker
is the co-founder
of XCellR8 Ltd
with 15 years
of cell culture
experience.
Carol has a BSc (Hons) in Physiology
and Pharmacology and a PhD from
FRAME
Alternatives
Laboratory,
University of Nottingham (FRAME =
Fund for the Replacement of Animals
in Medical Research). She has 5 years
experience in drug development
(Glaxo, Roche), and 8 years business
development experience as Manager
of European Operations of the cell
culture company, Cascade Biologics.
Email: [email protected]
Summer 2012 Volume 4 Issue 3