Proven Approaches for
Excerpted from an article by
Jason Nisler, Bio Applications
Specialist at Colder Products
INTERPHEX Booth No. 3629
Global companies that effectively
share internal expertise, best
practices, platform technologies
and specifications enhance speed to
market, eliminate redundant work, and
Imagine three separate engineering teams
within one company simultaneously
performing the same single-use connector
study to evaluate extractables and product
performance. The problem? The teams are
unaware of their overlapping efforts until a
supplier informs them.
In this real-life example, all three groups
pursued the same path with three
separate timelines, three separate facilities
conducting testing, and three separate
risk evaluations — at three times the cost.
Had the engineers known that coworkers
at other sites were working on the same
project, they could have collaborated to
shorten timelines or redeployed resources
to other projects.
Forward-thinking global biotech companies
are addressing redundancy and inefficiency
by developing communities of practice that
coordinate global process development
and identify, share, and leverage worldwide
best practices and specifications.
With the increasing relevance of global
markets, companies have migrated
away from centralized manufacturing to
developing regional manufacturing located
closer to customers. This trend, however, is
not without challenges.
• Lack of local resources. New sites
can face difficulty in finding experienced
talent due to high demand and limited
availability in a specific geographic area.
Efficient sharing of expertise that already
exists within the company can augment
local capabilities when needed.
• Lack of experience with single-use systems. Along with localizing
manufacturing sites, more companies are
employing single-use systems (SUS) to run
entire processes within GMP. However,
single-use technology (SUT) has only been
applied at manufacturing scale for about
10 years, so limited SUS experience at
some regional sites might delay product
launches to accommodate learning curves
or develop process specifications. By using
processes already developed and validated
at other sites, however, front-end design
time can be shortened.
• Process risk and time efficiency.
Lack of experience also can introduce risk
to drug manufacturing. Each new process
or technology exposes both the process
and product to potential contamination
and can require extensive time to
“debug” the design. Replicating validated
approaches from other sites helps reduce
these risks. Tapping into partners’
expertise is certainly valuable, too.
• Higher costs. With cost estimates of
over $1 billion1 to bring a drug product to
market, efficient use of resources is critical
to drug companies. Customized processes
and technologies for each manufacturing
site add costs by not taking advantage of
suppliers’ reduced cost of scale; by running
redundant, unnecessary tests; and by not
using human resources productively. If one
manufacturing site develops best practices
and specifications, other sites should
leverage those successes, saving time and
money along the way.
How to Implement
• Form a global standards team.
The configuration of global teams can
vary depending on several factors like
company culture and the number of sites
that must be accommodated. The main
idea, though, is to build a collaborative,
cohesive team. Choose one point person
to lead a team of designated subject
matter experts (SME) from each site.
Or designate one person to travel from
site to site to collect and share global
learnings and technology advancements.
• Collect and house expertise. Form
a community of practice — a group
of multi-site SMEs who share new
technologies, current challenges by site,
and best practices.
• Anticipate potential resistance —
at first. One of the biggest challenges
in global collaboration is overcoming
individual employees’ perceived
ownership of company expertise.
Make clear that sharing and efficiency
is expected as company practice
and highlight examples of successful
collaboration that enhanced speed or
reduced costs for everyone involved.
• Allow flexibility for business needs.
The benefits of harmonizing across
global sites are powerful and compelling;
however, there are times when local
flexibility is required. As always in drug
production, good judgment must prevail
to deliver the best product in the most
efficient, practical and responsible way. n