Biologics development represents a substantial advancement in
the pharmaceutical industry because of their promise and huge success in the oncology,
immunoscience, and cardiovascular disease areas. Prior to entering the marketed
product development phase, each biopharmaceutical needs to go through series of
stages that will allow or disallow the biologics asset to become a commercialized
product. Each of those phases includes development planning and designing of studies
to test relevant hypotheses to support the drug label if approved.
The current thesis will focus on the principles, assumptions,
and processes that are established to designate an asset (biologics) as a targeted
first-in-human program. First-in-human studies are included under phase 1 trials,
where initial human exposure is initiated to the investigational new drug (IND).
Phase 1 is critical since it affirms if a compound’s mechanisms of action in humans
and its development can result in a potentially new drug entity.
Subsequently, step by step initiatives and processes from the
perspective of different functional groups within the pharma will be revised to
outline the staged procedures, methods, critical, and non-critical paths taken when
a molecule is nominated as a clinical candidate. Overall alignment of deliverables
will be presented between the different functional areas that partake in the first-in-human
Strategic changes to the biologics development process, cell line
development with multiple candidate sequences, initial platform fit assessment for
a process, analytical and formulation will be acknowledged. Platform strategy for
drug substance production, as well as, drug product composition will be outlined
along with boilerplates for analytical method development to fit or not fit the
platform approach. The functional groups that
will be reviewed will be; Discovery, Cell line development, Drug Substance process
development, Formulation development, Toxicology, Quality, Drug Substance manufacturing,
Drug Product manufacturing, Stability and regulatory.
Keywords: Fast to First in Human,
Biologics, Development, Clinical.
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