www.biopharminternational.com April 2019 BioPharm International eBook 21
Outsourcing Resources Manufacturing
often limited material safety data
available on the clinical batch size
product, which can make it dif-
ficult to establish a cleaning proto-
col, thereby driving up costs. Many
larger customers do not want their
product on a line with clinical
batches, and this leads CMOs to
favor established products. Finally,
the smaller targeted patient popu-
lations per indication and the high
efficacy of biologicals have a direct
ef fec t on commercial demand,
which ca nnot be compa red to
standard blockbusters: CMOs have
to find a way to adapt their fill/fin-
ish technologies and business mod-
els to provide more flexibility for
their clients. This situation is not
simple and requires finding the
right balance between the parties'
different interests. Both have the
need to find a win-win solution,
which is the essence of a fruitful
and long-standing partnership.
There has been an increased
demand for clinical size batches of
lyophilized biologic products within
the CMO sector. In addition to the
usual concerns about process—
lyophilization cycle parameters, for
example—there is often an issue of
how to adequately clean the line
and equipment between each batch.
Within the sterile manufacturing
sector, for example, there has been a
general trend to transfer sterile prod-
ucts to CMOs. This is largely driven
by the fact that large bio/pharma-
ceutical companies want to trans-
fer their older sterile products out
and use that valuable manufactur-
ing space for newer biologic prod-
ucts. The cost of maintaing sterile
fill/finish facilities keeps increasing;
so do the challenges of complying
with more demanding regulatory
scrutiny. Furthermore, the pressure
around drug pricing has never been
higher. These factors are pushing
companies to strategically harmo-
nize their manufacturing capabili-
ties. In this case, outsourcing a larger
portion of the pipeline to CMOs can
provide more flexibility and access
to additional technology resources
and capacity.
A naly tical as well as chemis-
try, manufacturing, and control
(CMC) ser v ices are an integ ral
part of the drug manufacturing
process, even more so in sterile
and topical product manufactur-
ing. An ability to provide these
ser v ices on-site enhances qual-
ity, allows faster response times,
reduces produc t rejec t ion, a nd
enhances data integrity.
NAVIGATING
REGULATORY REQUIREMENTS
BioPharm: What should be in the
CMO's arsenal when there are sig-
nificant regulatory and legislative
changes afoot?
D a n z i (L e g a c y Ph a r m a c e u t i c a l s):
Being aware of, and ahead of, reg-
ulatory and legislative changes is
an important part of being suc-
cessful in the CMO industry. For
example, recent changes requir-
ing serialization have demanded
significant investment in equip-
ment and software to support the
reg ulator y requirements. CMOs
have to be ahead of their clients'
d e m a nd s wh i le i mple me nt i n g
these complex changes. This is
only possible when a CMO has
the experience as well as the flex-
ibilit y to rapidly adapt to offer
these services.
A not her e xa mple is t he ba n
on animal testing (for toxicit y
studies), which has required that
CMOs find alternative methods
to ensure products comply with
these new laws, while also com-
plying with existing dossiers and
regulatory requirements.
DEVELOPING GOOD
CMO/SPONSOR RELATIONSHIPS
BioPharm: How does a CMO appro-
priately manage the customer rela-
tionship?
Danzi (Legacy Pharmaceuticals): At
the end of the day, CMOs are a
customer-service business like so
many others in other industries.
It is important to focus on being
a seamless, responsive part of the
customers' supply chain. For new
customers, CMOs should be able
to provide complete product trans-
fer technical services to ensure
smooth transition and continuity
of supply to the market through
open, efficient and professional
communication during all stages.
Essentially, CMOs are an exten-
sion of the customer's global sup-
ply chain and as a partner, should
be easy to reach and talk to on a
daily basis.
REFERENCES
1. Research and Markets, "Biologics
Outsourcing Global Market—
Forecast to 2025," Report, August
2017, www.researchandmarkets.
com/reports/4375383/biologics-
outsourcing-global-market-forecast-to.
2. Results Healthcare, "Pharma &
Biotech 2017—Review of Outsourced
Manufacturing," Report, January
2017, https://resultshealthcare.com/
wp-content/uploads/2017/01/Results-
Healthcare_Pharma-Biotech-2017-
Review-of-outsourced-manufacturing_
Whitepaper.pdf.
BP
"… outsourcing
a larger portion
of the pipeline to
CMOs can provide
more flexibility and
access to additional
technology resources
and capacity."
—Mike Danzi
