In the past 7 years, the United States Food and Drug Administration (USFDA) has approved five Adeno-associated virus (AAV)-based gene therapy products treating a range of disorders and deadly monogenic diseases.

Adoptive cell therapies (ACTs) can deliver transformative approaches to patient care.

Antibody-drug conjugates (ADCs) are formed by antibodies targeting a specific antigen or antibody fragment covalently attached to payloads (such as small molecule cytotoxic drugs) via a linker.

BEBPA HCP 2024 -- Host-cell proteins (HCPs) pose a risk both to patient safety by means of immunogenic response, and to drug substance integrity by enzymatic digestion and degradation. Effective removal of the impurities while minimizing loss of the drug substance is a major challenge and milestone in the drug development life-cycle.

Bioburden testing of medical devices or products determines the presence of the total number of viable microorganisms present on and/or within a device, which is expressed as colony forming unit(s) (CFUs) per device.

To help you determine if in-house solvent compatibility testing is right for your medical device, this article will discuss the basic information to provide a framework of test material to be tested -- aligned with the steps to perform the testing, which are simple and require minimal supplies.

ECI Vaccine IX 2024 -- Self-amplifying RNA (sa mRNA) formulated in lipid nanoparticles (LNPs) is a novel vaccine modality and is being used to develop a Marburg Virus vaccine comprising the Glycoprotein (MARV) sa mRNA. Imidazoquinoline TLR-7 agonists have been encapsulated with the MARV sa mRNA-LNP with the aim of testing for adjuvancy in vivo.

ECI Vaccine IX 2024 -- Self-amplifying RNA (sa mRNA) formulated in lipid nanoparticles (LNPs) is a novel vaccine modality and is being used to develop a Marburg Virus vaccine comprising the Glycoprotein (MARV) sa mRNA.

ECI Vaccine IX 2024 -- Self-amplifying RNA (sa mRNA) formulated in lipid nanoparticles (LNPs) is a novel vaccine modality and is being used to develop a Marburg Virus vaccine comprising the Glycoprotein (MARV) sa mRNA.

OBN & University of Reading Pain Research and Therapeutics Conference 2024 -- Drug abuse liability assessment is required for drugs (parent or major metabolite) that penetrate the brain, regardless of the therapeutic indication.