PharmTech.com Trends in Manufacturing eBook May 2024 Pharmaceutical Technology
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MULTIMODAL
on outside walls in order to comply with building and
safety codes for hazardous materials (Class 1, Divi-
sion 1) (7). Oligo manufacturing is also more likely to
implement bidirectional f low to improve efficiency
during manufacturing and will not require any form
of biosafety classification or higher-level cleanliness
classification for product protection (Grade D).
mRNA and LNP. While these are two distinct com-
ponents used in the manufacture of mRNA-based
therapeutics, both are critical to providing the ther-
apeutic benefit to the patient. In simple terms, the
mRNA provides the genetic instructions for cells to
produce a specific protein, while the LNP encapsu-
lates and delivers the mRNA into cells, protecting it
from degradation and facilitating its uptake.
Neither mRNA nor LNP requires special biosafety
considerations. Nor do either rely on a need for uni-
directional f lows or higher-level cleanliness classifi-
cations. However, as with oligo products, LNP manu-
facturing requires the use of water-miscible solvents
in a buffer solution (Figure 3).
Summary
Multimodal manufacturing is progressively becom-
ing a part of the ATMP manufacturing landscape. In
an industry survey, more than half of survey respon-
dents plan to implement multimodal solutions within
the next two years (Figure 4) (8).
FIGURE . Illustration shows a messenger RNA (mRNA) and lipid nanoparticle
(LNP) layout. MFG is manufacturing. mRNA is messenger RNA. LNP is lipid
nanoparticle. CNC/NC is controlled non-classified/non-classified.
