SPS 2023 -- Lipid nanoparticle (LNP)-encapsulating messenger RNA (mRNA)-based therapeutics and vaccines are an established and emerging drug modality for various indications.
APA 2023 -- A study assessing the feasibility of performing quantitative analysis of Pembrolizumab in human whole blood collected using Mitra� (Neoteryx) volumetric adsorptive microsampling (VAMS) devices was conducted.
ESCCA 2023 -- With the recent advances in cancer vaccines and the use of immunotherapy for treatment of multiple tumor types, immune monitoring has become increasingly critical to define patient immunological profiles and guide treatment decisions.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q14 is a new quality document describing analytical procedure development. Previously, no ICH guidance specifically covered analytical method development, resulting in a lack of clarity on what to present to regulators.
The underlying principle for biopharmaceutical development and manufacturing is to provide a drug product that is both safe and efficacious for the patient. Therefore, manufacturing of any drug substance and drug product must demonstrate consistent production of a quality product, which must be shown to be stable over its intended shelf life.
BEBPA EUR Bioassay 2023 -- RNA vaccines, comprising a mRNA encapsulated in a lipid nanoparticle (LNP), are a new modality for rapid development of synthetic prophylactic and therapeutic vaccines.
BEBPA EUR Bioassay 2023 -- RNA vaccines, comprising a mRNA encapsulated in a lipid nanoparticle (LNP), are a new modality for rapid development of synthetic prophylactic and therapeutic vaccines.
Cell and gene therapies (CGT) are bringing new options to patients while revolutionizing the future of medicine. As you drive this innovation, we're here to provide the global infrastructure you need combined with the personalized experience you deserve.
When setting out to start a cell or gene therapy program, many biotech and pharmaceutical companies inadvertently assume that the preclinical drug development milestones will be similar to traditional therapies.
