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FEATURED REPORT
Formulation,
Fill and Finish
Finding Solutions for
Evolving Modalities
JUNE 2025
01 Trends in Biologics Formulation, Fill–Finish,
and Delivery
Peggy Wright
06 Overcoming Complexities in Technology
Transfer for Sterile Injectables
Jim Donovan
10 Mastering Protein Stability in Injectable
Biopharmaceuticals
Andrea Allmendinger, Michael Adler, and
Hanns-Christian Mahler
14 Improving Polysorbate Stability in Drug
Substance Through Process Optimization
Dong-Gu Oh, Dongok Shin, Lalit Saxena,
Dongsun Ryu, and Yonghwan Jin
21 Resources
IMAGE COURTESY OF VETTER PHARMA
(HTTPS://WWW.VETTER-PHARMA.COM)
Breakthroughs
in Every Drop
Introducing WuXiHigh 2.0 for
TM
High-Concentration Biologics
Quality.
FEATURED REPORT Formulation, Fill and
Breakthroughs in Every Drop Introducing WuXiHigh
Trends in Biologics Formulation, Fill–Finish, and
Antibody formulations become extremely VISCOUS wh
Advanced Technologies and the Future of Drug Deli
The filling industry predicts that GLP-1 demand w
tradeoff.” For example, some product proteins ine
Overcoming Complexities in Technology Transfer fo
relative to 14 reference products (2). The global
Proactive Planning and Risk Management: A s
; ov -c E v
Mastering Protein Stability in Injectable Biophar
need to understand and potentially mitigate chall
)LJXUH ɄStress factors that can affect the qualit
design studies of each unit operations within a f
Polysorbate Stability in Bulk Drug Substance Cont
7DEOH ɄSample information used for scaled-down mo
charged aerosol detector (CAD) with high- perform
)LJXUH ɄPS80 kinetics study results of eluates fr
)LJXUH ɄScatter plot of Monte Carlo simulation re
)LJXUH ɄCharge-variant profiles of biological dru
of Current Root Causes. Int. J. Pharm. 552(1–2) 2
Industry Resources Microneedle Manufactur