The confluence of innovation in therapeutics and regulation: recent cmc considerations
Fecha
2020Autor
Gutierrez, Lucas
Cauchon, Nina S.
Christian, Twinkle R.
Giffin, Mike
Abernathy, Michael J.
Documentos PDF
Resumen
The field of human therapeutics has expanded tremendously from small molecules to complex
biological modalities, and this trend has accelerated in the last two decades with a greater diversity in the
types and applications of novel modalities, accompanied by increasing sophistication in drug delivery
technology. These innovations have led to a corresponding increase in the number of therapies seeking
regulatory approval, and as the industry continues to evolve regulations will need to adapt to the everchanging landscape. The growth in this field thus represents a challenge for regulatory authorities as well
as for sponsors.
This review provides a brief description of novel biologics, including innovative antibody
therapeutics, genetic modification technologies, new developments in vaccines, and multifunctional
modalities. It also describes a few pertinent drug delivery mechanisms such as nanoparticles, liposomes,
coformulation, recombinant human hyaluronidase for subcutaneous delivery, pulmonary delivery, and 3D
printing. In addition, it provides an overview of the current CMC regulatory challenges and discusses
potential methods of accelerating regulatory mechanisms for more efficient approvals. Finally, we look at
the future of biotherapeutics and emphasize the need to bring these modalities to the forefront of patient
care from a global perspective as effectively as possible.
Palabras clave
Antibody Drug(s); Automation; Drug Design; Gene Therapy; Immunotherapy; Liposome; Nanoparticle(s); Regulatory Science; Targeted Drug Delivery; VaccinesEnlace al recurso
https://doi.org/10.1016/j.xphs.2020.09.025Colecciones
Estadísticas Google Analytics
Comentarios
Respuesta Comentario Repositorio Expeditio
Gracias por tomarse el tiempo para darnos su opinión.