26 BioPharm International eBook March 2021 www.biopharminternational.com
best practices for development of
patient-centric specifications. Case
studies were used to highlight how
individual IQ member companies
used process and product under-
standing to justify specifications
and specification ranges.
I n 2 019, t he WG publ i she d
a white paper on the FIH speci-
f icat ion ef for t, which includes
results of the blinded survey and
a specification platform to support
mAb/ADC FIH products (6). The
platform specifications and their
just if icat ions prov ide a f ra me-
work of attributes, methods, and
acceptance criteria that have been
found to be broadly applicable to
FIH mAbs and ADCs. The platform
specifications provide a guide for
industry and regulators that bal-
ances the depth of development
efforts at the FIH stage against the
critical requirement of ensuring
product quality and patient safety.
A subsequent white paper illus-
trates how systematic, risk-based
development approaches result in
a greater understanding of attri-
bute criticalit y, method perfor-
mance, and the potential for the
process to impact product qual-
ity (7). This white paper outlines
c r it ic a l e le me nt s a nd re qu i re -
ments of commercial specifica-
tions and explains how attribute
understanding can be combined
with ICH Q6B and pharmacopeia
requirements to provide flexibil-
it y for a grow ing supply chain
demand and lifecycle improve-
ment activities while ensuring the
product is safe and efficacious.
T he WG a lso com mu n icated
t hei r f i nd i ngs at major globa l
industry conferences and work-
shops (14–19) to drive acceptance
and application of the approach
outside of IQ , including collabo-
rations with the PhRMA Patient
Centric Quality Standards team
on commercial specifications (18)
and a panel discusison with regu-
latory representatives.
Shared authorship of the publica-
tions in the WG limited individual
effort but also allowed team reviews
and distribution of specific sections
to respective subject-matter experts.
Importantly diverse cross-company
participation in the WG facilitated
broader access to case studies from
IQ company network and ensured
output from the WG represented a
broad cross-industry position.
The publications and conference
presentations of the WG helped
close the gap in guidance on how
to implement science- and risk-
based principles for FIH and com-
mercial mAb and ADC products
by providing broadly applicable
industry standards. These stan-
dards can now be applied across
biopharmaceutical companies to
further development and accep-
tance of the approach. The WG's
collaboration w ith PhR M A and
inclusion of regulatory represen-
tatives in the public discussions
reinforced that the risk- and sci-
ence-based approach has w ide-
s p r e a d i nd u s t r y s up p o r t a nd
influenced current efforts to revise
ICH Q6 to incorporate science and
risk-based principles.
CONCLUSION
The Bio CMC LG will continue to
strategically focus on emerging
CMC challenges that are of high
priority to the IQ membership to
facilitate rapid, nimble responses
that foster innovative, science/
data-based solutions to support
patient access to critical medicines.
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BP
ABOUT THE AUTHORS
S a r o j R a m d a s i s G S K f e l -
low and director, CMC reg ula-
tory strategy and advocacy with
GlaxoSmithKline; Renata Varga
is principal scientist, Teva Branded
Phar maceutical P roduc ts R&D,
Inc; Mar tin Gastens is senior
director program management,
AbbVie Deutschland GmbH & Co.
KG; Twinkle R. Christian is pro-
cess development scientist, Bharat
Jagannathan is process develop-
ment senior scientist, and Barbara
Rellahan
*
, rellahan@amgen.com,
is director, product quality, all
at Amgen; Jillian Brady is man-
ager, science, regulation & policy,
Faegre Drinker Biddle & Reath LLP;
all authors are members of the IQ
Consortium.
*
To whom a l l cor re sp onde nce
should be addressed.
Regulatory Sourcebook Quality Collaboration
