ARVO 2024 -- The mouse is an important species for the development of gene therapies because transgenic disease models are often available. Mouse eyes are susceptible to complications associated with the subretinal injection procedures because of their small size and relatively large lens.

ARVO 2024 -- Proliferative vitreoretinopathy (PVR) occurs in up to 10% of rhegmatogenous retinal detachments (RRDs) and is the leading cause of RRDs surgical failure, manifesting in poor visual outcomes and recurrent surgical interventions.

SETAC Europe 2024 -- Per- and polyfluoroalkyl substances (PFAS) are a class of synthetic organofluorine compounds that have become a concern due to their persistence in the environment following extensive use over the last few decades.

ASGCT 2024 -- Adeno-associated virus (AAV) remains the viral vector of choice for in vivo gene therapy. However, there continue to be safety concerns regarding AAV therapeutics. The empty:full ratio of AAV vectors has been highlighted as an important critical quality attribute (CQA).

ASGCT 2024 -- 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.