Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 29
PharmTech: What are some of the themes that are
driving new research?
Ganguly: Lyo is a batch process, and, as FDA
pushes the industry to consider continuous pro-
cessing, we are seeing greater interest in looking
into continuous lyophilization processes. Another
industry trend is the move to smaller batches. In
the future, we will need equipment that can deal
with custom batches of varying sizes.
Yet another major trend for the future is the
move to patient self-administered devices, which
will require different vials and container systems,
cartridges, syringes, and specialized devices/
equipment. And then there is the move to per-
sonalized medicine.
Each of these areas poses more challenges, and
today, most processing equipment is still largely
based on legacy designs.
PharmTech: Where is work going on to develop
continuous lyophilization processes?
Ganguly: A number of academic groups are look-
ing into developing continuous lyophilization,
including the University of Ghent, MIT, and the
University of Torino.
PharmTech: What will be needed to facilitate
use of dual chamber syringes and cartridges and
smaller batches?
Ganguly: Work began in this area over 10 years
ago years ago. One of the first papers was from
the University of Lyons, and there have been sev-
eral contributions from the late Prof Mike Pikal's
research group at Purdue, as well as from the
University of Munich, Vetter, and Pfizer to name
just a few. As far as the move to smaller batches
are concerned, we surely will see a move towards
smaller, more efficient systems with better reli-
ability and control enabled by PAT from today.
PharmTech: What are your goals for the commit-
tee, in the short and mid term?
Ganguly: Short term, we are inviting members to
contribute to E-55.05. We want the group to reflect
the different voices involved in different points of
view , including members from industry, academia,
tech equipment vendors, vial manufacturers, ex-
cipient manufacturers, and regulatory profession-
als. Mid-term goals will be to convert best prac-
tices paper issues into fundamental standards and
standard practice within the industry. We've had
good conversations so far within the industry on
the first best practices paper.
PharmTech: Your PhD work involved modeling for
pressure and vapor f low. Is the industry becoming
more accepting of advanced modeling and control
for lyophilization?
G a n g u l y: As I see it, t he lyo com mu nit y is
showing increasing levels of confidence in using
modeling to understand processes, equipment,
and product (3). Specific examples include use
of t he LyoCa lcu lator or a li ke physics based
models, computational f luid dynamics to better
understand processes, and qualif y equipment
and address any gaps in understanding of its
characteristics.
References
1. PharmTech Editors, "Experts Set a 10-Year Roadmap for Op-
timizing Lyophilization," PharmTech.com, September 14, 2017,
www.pharmtech.com/experts-set-10-year-roadmap-optimizing-
lyophilization-0
2. S. Nail et al., "Best Practices for Process Monitoring Instrumenta-
tion of Pharmaceutical Freeze-drying," AAPS PharmSciTech, 18
(7), 2379-2393 (October 2017).
3. S. Tchessalov et al., "An Industry Perspective on the Applica-
tion of Modeling to Lyophilization Process Scaleup and Transfer,"
Americanpharmaceuticalreview.com, www.americanpharmaceu-
ticalreview.com/Featured-Articles/335416-An-Industry-Perspec-
tive-on-the-Application-of-Modeling-to-Lyophilization-Process-
Scale-up-and-Transfer/PT
