The global pandemic outbreak, SARS-COV-2, which causes COVID-19, has
coerced numerous pharmaceutical companies to sprint for the vaccine and
therapeutic biologics development. Most of the therapeutic biologics are
common human IgG antibodies, which were identified by next-generation
sequencing with the B cells from the convalescent patients in less than
one-month post-infection. While the global public health emergency calls
for medications urgently, it saves lives to expedite the clinical trials
of biologics as much as possible, hence the biologics development
strategies are unprecedentedly challenged. Since the advent of
therapeutic biologics, transfection, and selection strategy has been
continuously improving for developing more robust cell lines with
greater productivity and efficiency. Next-generation sequencing (NGS)
has also been implemented into cell bank testing for acceleration. These
recent advances enable us to rethink and reshape the chemistry,
manufacturing and controls (CMC) strategy against the pandemic
outbreaks, to start supplying cGMP materials for the life-saving
clinical trials as soon as possible. We elucidated an accelerated CMC
workflow for biologics against pandemics, including using cGMP-compliant
pool materials for Phase I clinical trials, selecting the final clone
with similar product quality as Phase I materials for late-stage
development and commercial production and matching product quality among
different manufacturing stages.
Efficacy of Immunobiologic and Small Molecule Inhibitor Drugs for Psoriasis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials