www.biopharminternational.com Partnerships for Outsourcing eBook May 2023 BioPharm International
®
27
Fill/Finish
• Optimize flexibility—Sterile fill/finish capacity
has to be f lexible and dynamic to address the
future needs of the market. The f lexibility and
resiliency of the supply chain are also crucial.
How to scale up efficiently and be operationally
agile to quickly address issues and opportunities
is essential.
• Ensure diversity—Drugs destined for multiple
international markets demand f lexible process-
ing and manufacturing capabilities as well as
advanced digital automation to handle the com-
plexity and diversity of primary packaging rang-
ing from vials and ampoules to prefilled syringes
and cartridges.
• Harness advances in lyophilization—The in-
herent cryogenic logistics and storage costs as-
sociated with many vaccines pose a challenge,
especially when shipping to emerging markets
where the necessary cold-chain infrastructure is
not in place. Advances in lyophilization mean it
is increasingly possible to lyophilize vaccine for-
mulations to reduce temperature requirements
and ease distribution complexity.
• Collaborate—Communication and openness be-
tween vaccine developers and CDMOs are crucial
to the success of any aseptic processing project.
By working together, and harnessing collective
expertise, it is possible to identify potential bot-
tlenecks and arrive at viable solutions to ensure
projects are delivered on time, whatever their
size or nature.
The benefits of expert partnerships
The COVID-19 pandemic highlighted various vulner-
abilities in the pharmaceutical ecosystem. However,
the speed and flexibility of the vaccine roll-out demon-
strated the industry's many strengths, including the
effectiveness of its aseptic filling and other contract
partners to support developers' innovation.
A sept ic f i l l/f i n i sh c a n be a c h a l leng i ng a nd
time-consuming necessity for vaccine production.
But the past two years have demonstrated that, by
engaging expert CDMO partners with the high-qual-
it y sterile infrastructure in place, it is possible to
overcome c h a l lenges a nd del iver l a rge-volu me
projects rapidly. With such partnerships in place,
pharmaceutical companies can be confident that they
are well-equipped to accelerate vaccine development
in the future.
References
1. Statista. Revenue of the Worldwide Pharmaceuti-
cal Market from 2001 to 2022 (in billion US dollars).
Statistca.com (accessed April 13, 2023).
2. IQVIA. Global Medicine Spending and Usage Trends:
Outlook to 2025. Institute Report. April 28, 2021. ■
Sterilization's Horizon: Improving Automation,
Single-Use Technologies, and Annex 1
In this exclusive Drug Digest video interview, editors from
BioPharm International
®
's sister publication, Pharmaceutical
Technology
®
, interview experts in sterilization and aseptic
processing. Alex Van Hagen of Watson-Marlow Fluid Technol-
ogy Solutions discusses how to approach selecting sterilization
methods, installation of aseptic machinery, how single-use
technology factors into aseptic processing, and areas for
improved automation. In a quick-fire interview, Hamish Hogg
of Cherwell Laboratories talks about the eagerly anticipated
publication of the revised EU GMP Annex 1 guidance,
potentially problematic aspects of the revised guidance,
and tips and tricks for companies to ensure compliance.
For more episodes, visit our PharmTech.com!
Dr. Alex Van Hagen
is a molecular biologist by training and the
current North UK life sciences sector specialist
for Watson-Marlow Fluid Technology Solutions.
Hamish Hogg
has been the microbiology product specialist
at Cherwell Laboratories since January 2019.
