Advanced therapy medicinal products (ATMPs), such as somatic cell-therapy medicinal
products or tissue-engineered products for human use, offer new and potentially curative …

Adeno-associated viruses (AAVs) have become the delivery medium of choice for a variety
of genomic medicine applications ie, gene therapy, gene editing/regulation, and ex-vivo cell …

Background aims Advanced therapy medicinal products (ATMPs) are novel drugs based on
genes, cells or tissues developed to treat many different diseases. Stability studies of each …

Immuno-PET is a molecular imaging technique utilizing positron emission tomography (PET)
to measure the biodistribution of an antibody species labeled with a radioactive isotope …

The assurance of sterility of a parenteral drug product, prior to any human use, is a
regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must …

Biopharmaceutical drug products may be exposed to temperatures outside of the intended
storage temperature range (typically 2–8° C) during commercial distribution due to …

This chapter discusses aspects and challenges related to stability, formulation, and delivery
of biopharmaceuticals. While many of the stability elements are both applicable to drug …

As the complexities of the pharmaceuticals needed to prevail over serious diseases
continue to grow, the need for technologies to enable their efficient storage and delivery are …

Abstract Development of novel pharmaceutical drug modalities has created a need for
frozen storage and transportation. Accurate and easy assessment of container closure …

Biological drugs comprise a wide field of different modalities with respect to structure,
pharmacokinetics and pharmacological function. Considerable non-clinical experience in …