24 BioPharm International eBook March 2021 www.biopharminternational.com
faced by biotechnology companies
and communicated proposed solu-
tions through peer-reviewed posi-
tion papers, conference workshops
a nd presentat ions (2 – 8), webi-
nars, and collaboration with other
industry and stakeholder groups,
including regulators (Figure 1).
The activities of two working
groups— on the safety handling
of biologic drugs in closed-system
transfer devices in healthcare set-
tings and the need for phase-ap-
propriate specifications—illustrate
the value of pre-competitve col-
l a b o r a t i v e e f f o r t s o f t h e I Q
Consortium.
BIOLOGIC DRUGS AND CSTDs
IN HEALTHCARE SETTINGS
Closed-system transfer devices (CSTDs),
when appropriately designed and
used, offer enhanced protection
to hea lt hc a re worke r s aga i n st
potential occupational exposure
to hazardous drugs during clinical
preparation and administration.
Although there has been much
focus on CSTDs in the context of
drug containment and safety, dis-
cussion on the compatibility of
CSTDs with biological drug prod-
ucts has been nascent.
CSTD use may result in incom-
patibilit y issues, including v ial
rubber stopper coring/shedding,
d r ug pro duc t ag g regat ion a nd
particle formation due to lubri-
cants or other mater ials in the
device fluid path, and inaccurate
dosing due to variability in CSTD
hold up volumes.
When the CSTD WG was estab-
lished in March 2019, the pend-
ing implementation of United States
Pharmacopeia (USP ) General Chapter
<800> "Hazardous Drugs– Handling in
Healthcare Set tings" at the end of
2019, would have made CST Ds
mandator y for biolog ics classi-
fied as hazardous by the National
Institute for Occupational Safety
and Health (NIOSH). The poten-
tial implementation of USP <800>
created a critical gap in the aware-
ness regarding technical challenges
among health authorities, phar-
macy/nursing associations, and
device manufacturers.
The CSTD WG works to influ-
ence the technical, clinical, and
reg ulator y landscape associated
with the usage of CSTDs with bio-
logics. Within three months of
conceptualization, the WG spon-
sored an Oct. 29, 2019 workshop,
Use of Closed System Tra nsfer
Devices with Biologics, to review
the risks and challenges associated
with the use of CSTDs with bio-
logics. Another objective was to set
the stage for further dialog towards
alignment on the appropriate use
and implementation of CSTDs for
biologics, in particular, the tech-
nical challenges and risks associ-
ated with CSTDs from a biologic
compatibility and product quality
Regulatory Sourcebook Quality Collaboration
Figure 1. Bio CMC Leadership Group portfolio and accomplishments. See reference section for cited references.
FIGURE
COURTESY
OF
THE
AUTHORS.
