Since the mid-1980s, when the first monoclonal antibodies
(mAbs) were launched to treat human diseases, this product
class has witnessed tremendous success. MAbs and mAb-derived
products are now routinely used to treat patients for a variety of
deadly or debilitating diseases. Many more compounds are currently
in various stages of clinical development for the treatment of
cancers, infections, inflammatory/autoimmune diseases, and other
disorders. Many mAbs have reached blockbuster status. Therapeutic
success, in turn, has spurred innovation in the technical
development and manufacturing of mAbs. The antibody structure
now serves as a framework to create related molecular entities, such
as fragments, Fc-fusions, bispecifics, and antibody drug conjugates,
with the goal of optimizing therapeutic potential. Scientific
advances in molecular biology have enabled the transition from
murine to fully human mAbs, thus, reducing the risk of unintended
Improvements in expression systems and the development of
novel cell substrates have boosted titers, and efficiency gains have
been realized in manufacturing by adopting platform processes for
upstream and downstream operations. Many mAb manufacturers
were early adopters of Quality by Design (QbD) principles.
Years of accumulated process knowledge,
platform approaches, and application
of QbD-enabled control strategies have
enabled solutions for adventitious agent
clearance, and even elimination of routine
testing for certain impurity types.
Despite these achievements, changes in
regulations and advances in in silico and
computational technology continually drive
the need to reexamine existing practices and
identify opportunities for improvement.
In 2008, PDA launched the first of a
series of workshops on mAbs to sustain an
ongoing dialogue between industry and
regulators. This dialogue was initiated after
publication in 2007 of the draft EMA
guideline, Development, Production, Characterization
and Specification for Monoclonal
Antibodies and Related Products.
PDA had provided comments to the draft
guideline and was subsequently invited
to meet with the Biologics Working Party
to discuss industry feedback. The need to
discuss current and emerging topics on a
periodic basis emerged. PDA’s mAb workshops
over the years have covered relevant
topics such as QbD, quality attributes,
immunogenicity, control strategy, and innovative
This year marks the 10th anniversary
of this series of successful workshops.
PDA Europe and the mAb workshop
planning committee are pleased to announce
the theme of this year’s mAb
workshop: “Manufacturing & Analytics
Considerations for Antibodies and
Related Products – A Decade of Progress.”
The objective of the workshop is
to highlight achievements reached in the
manufacturing and analysis of mAbs and
related products over the past 10 years
and explore innovative technologies and
approaches that will influence the next decade
of mAb development and manufacturing.
As in previous years, the workshop
program features a session on recent regulatory
developments, featuring renowned
European regulators, as well as case studies
and panel discussions on upstream and
downstream process development, control
strategy design, antibody-related products,
and technological innovations presented
by industry leaders.
This year, in addition to being the 10th
anniversary, the conference will also be
part of the PDA Europe Exchange Series.
This new format intends to give attendees
the chance to “Meet, Exchange and
Connect” with other professionals from
around the globe by also providing access
to the 2nd PDA Europe Particles in Injectables
Conference, which will take place at
the same time, in the same location.
Learn more about the Workshop on Monoclonal Antibodies and Particles in Injectables Conference.