The development of biopharmaceutical
products is shifting from a traditional
platform approach to one comprised of
complex modalities like chimeric antigen
receptor T-cell therapies, oligonucleotides
and oncolytic immunotherapy viruses. This
means traditional reliance on a platform
comprised of monoclonal antibody (mAb)
products may not be adequate for newer,
unconventional therapies. Instead, an
end-to-end holistic strategy that integrates
formulation and package development with
manufacturing and administration is necessary
to ensure that drug product quality,
safety and efficacy are not compromised
throughout the shelf life of a product.