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.
Immuno-oncology drug development is inherently complex and requires special considerations across the entire spectrum, from preclinical to commercial support for the approved product.
This white paper provides an engaging background on cell and gene therapies, a look into recent therapeutic applications and future trends in the cell and gene therapy technology space.
This white paper provides the current position on the key cell types and their role in cancer immunotherapies, with a more in-depth focus on chimeric antigen receptor (CAR) T-cell therapies.
