The chimeric antigen receptor (CAR) T-cell journey includes three distinct phases: collecting the patient's white blood cells through apheresis, modifying the patient's T-cells to manufacture the CAR T-cells, and, finally, infusing the new fighter T-cells into the patient.
An emerging biotech company was searching for an experienced partner to help their early-phase efforts to advance a gene therapy that targeted a rare neurodegenerative disease.
National AALAS 2023 -- The surgical implantation of intra-vascular catheters for chronic direct vascular access has produced an essential animal model in rodent preclinical research. Historically, rat catheterization systems included an external port secured via a thoracic harness.
As a promising therapeutic candidate targeting rare inherited retinal diseases was spun out of an academic medical center, an emerging biotech needed a knowledgeable and agile partner to provide analytical testing of their product and ensure the project followed an expedited timeline.
ACVP 2023 -- The introduction of vascular access button (VAB) devices has increased the availability and efficiency of long-term direct vascular access for preclinical research in multiple species. Life-limiting complications from their implantation and usage is rarely reported in the literature.
Biocompatibility endpoints required for assessment as a part of a risk-based evaluation of medical device safety are provided by ISO 10993-1 and various international regulatory body standards and guidance documents.
The biocompatibility evaluation of medical devices is governed by standards, guidance documents and other regulations from around the world. These include, but are not limited to, International Organization for Standardization (ISO) 10993; U.S.
SETAC NA 2023 -- Environmental risk assessments (ERAs) for chemical, crop protection products and pharmaceuticals are necessary to fulfil global registration requirements. The data needed to describe environmental fate and aquatic or terrestrial hazards can lead to large testing programs and potentially high vertebrate usage.
