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\begin{document}

\title{Status and future developments for downstream processing of biological
products Perspectives from the Recovery XIX yield roundtable discussions}



\author[1]{Alois Jungbauer}%
\author[2]{Gisela Ferreira}%
\author[3]{Michelle Butler}%
\author[4]{Susan D’ Costa}%
\author[5]{Kevin Brower}%
\author[6]{Andrea C.M.E Rayat}%
\author[7]{Richard Willson}%
\affil[1]{Universitat fur Bodenkultur Department fur Biotechnologie}%
\affil[2]{AstraZeneca R\&D Gaithersburg}%
\affil[3]{F Hoffmann-La Roche AG Research and Development Division}%
\affil[4]{Genezen Laboratories}%
\affil[5]{Mammalian Platform}%
\affil[6]{University College London}%
\affil[7]{University of Houston}%


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  \date{June 16, 2024}


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\begin{abstract}
Governments and biopharmaceutical organizations aggressively leveraged
expeditious communication capabilities, decision models and global
strategies to make a COVID-19 vaccine happen within a period of 12
months. This was an unusual effort and cannot be transferred to normal
times. However, this focus on a single vaccine has also led to other
treatments and drug developments being sidelined. Society expects the
pharmaceutical industry to provide an uninterrupted supply of medicines.
However, it is often overlooked how complex the manufacture of these
compounds is and what logistics are required, not to mention the time
needed to develop new drugs. The overarching theme, therefore, is
patient access and how we can help ensure access and extend it to low-
and middle-income countries. Despite unceasing efforts to make
medications available to all patient populations, this must never be
done at the expense of patient safety. A major fraction of the costs in
biopharmaceutical manufacturing are for drug discovery, process
development, and clinical studies. Infrastructure costs are very
difficult to quantify because they often depend on whether a greenfield
facility or an existing, depreciated facility is used or adapted for a
new product. To accelerate process development concepts of platform
process and prior knowledge are increasingly leveraged. While more
traditional protein therapeutics continue to dominate the field, we are
also experiencing the exciting emergence and evolution of other
therapeutic formats (bispecifics, tetravalent mAbs, antibody-drug
conjugates, enzymes, peptides, etc.) that offer unique treatment options
for patients. Protein modalities are still dominant, but new modalities
are being developed that can be learned from including advanced
therapeutics like cell and gene therapies. The industry must develop a
model-based strategy for process development and technologies such as
continuous integrated biomanufacturing must be adopted. The overall
conclusion is that the pandemic pace was unsustainable, focused on
vaccine delivery at the expense of other modalities/disease targets, and
had implications for professional and personal life (work-life balance).
Routinely reducing development time from 10 years to 1 year is nearly
impossible to achieve. Environmental aspects of sustainable downstream
processing are also described.%
\end{abstract}%



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