www.biopharminternational.com Manufacturing and Facilities eBook 2023 BioPharm International
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Facilities:
OligOnucleOtides
biotech faci lities, except t hat t hey a lso carr y t he
current good manufacturing practice compliance
requirements of an FDA regulated drug substance
facility. In the current therapeutic landscape of ad-
vanced modalities, SPOS processes are among the
most complex a nd cost ly faci lit ies to design a nd
construct.
A s la rge a nd sm a l l compa n ies a l i ke d r ive ad-
vances that bring more oligo therapeutics to mar-
ket a nd ex pa nd pat ient popu lat ion s t hey ser ve,
SPOS processes will continue to be a realit y. This
demands commensurate grow th in expertise and
nuanced understanding to ensure that production
facilities can be efficiently implemented with robust
designs for safe and sustainable operations to serve
the patients for whom this expanding therapeutic
area brings such promise.
References
1. Internationa l Code Counci l. 2024 Internationa l
Building Code. https://codes.iccsafe.org/content/
IBC2024P1. August 23, 2023.
2. Inter nat iona l Code Counci l. 2021 Inter nat iona l
Fire Code (IFC). https://codes.iccsafe.org/content/
IFC2021P2. August 23, 2023.
3. Nat iona l Fire Protect ion Associat ion. NFPA 30:
F l a m m able a nd Combu s t ible L iqu id s. ht t ps://
w w w.n f pa.org/codes-a nd-st a nda rds/a l l-codes-
and-standards/list-of-codes-and-standards/detail.
August 23, 2023.
4. Nat iona l Fire Protect ion Associat ion. NFPA 70:
National Electrical Code. https://w w w.nf pa.org/
codes-a nd-sta nda rds/a l l-codes-a nd-sta nda rds/
l i st-of-codes-a nd-st a nd a rd s/det a i l. Aug u st 23,
2023
5. National Fire Protection Association. NFPA 497:
Recommended Practice for the Classif ication of
Flammable Liquids, Gases, or Vapors and of Haz-
ardous (Classified) Locations for Electrical Instal-
lations in Chemical Process Areas. https://w w w.
nfpa.org/codes-and-standards/all-codes-and-stan-
dards/list-of-codes-and-standards/detail. August
23, 2023.
■
Oligonucleotide Market Update
metabion, a German manufacturer of custom oligonucleotides, announced on July 11, 2023 that it has increased its global
production capacity for both diagnostic and new therapeutic oligonucleotides, as well as derivatives, at its new facility in
Munich East, Germany. The company completed a double-digit million euro investment in the 2023 first quarter for the
expansion project.
The facility is dedicated to the manufacturing of small-, mid-, and large-scale oligonucleotide components for
in-vitro diagnostics/analyte-specific reagents oligonucleotides as well as mid-/large-scale oligonucleotides for
R&D and therapeutic applications. The increased capacity is intended to support the rising demand in Europe and
worldwide for diagnostic and therapeutic oligonucleotides, according to a company press release (1).
On Oct. 19, 2023, Waters Corporation announced that it has launched OligoWorks solid phase extraction (SPE) kits
and components, which are meant to improve sample preparation for liquid chromatography (LC)–mass spectrometry
(MS)-based bioanalytical quantitation of therapeutic oligonucleotides.
The kits are designed to deliver up to 2x higher oligonucleotide recovery from biofluids, according to a company
press release. The kits' design also delivers improved LC-MS sensitivity and reproducibility for supporting robust
quantitation. Because these capabilities enable lower limits of quantitation, the kits can reduce the need for repeat
experiments.
The kits also use an innovative, enzyme-enhanced, and detergent-free sample pre-treatment that, according to
Waters in the press release, reduces washing steps and improves mass spectrometer compatibility. This design
enables for direct injection LC–MS analysis and is also what allows for the lower limits of quantitation. The kits can
also be fully automated, which can improve productivity or simply help scientists gain back time via the reduction of
manual steps and oversight (2).
References
1. Mirasol, F. metabion Expands Oligonucleotide Production Capacity in Germany. BioPharmInternational.com, July 14, 2023.
2. Waters. Waters Accelerates Oligonucleotide Bioanalysis with the Launch of OligoWorks™ SPE Workflow and Kits. Press
Release. Oct. 19, 2023.
—The Editors of BioPharm International
®
