Diagnostics
THE NATIONAL EXAM ONE MUST PASS TO BECOME A LICENSED CLINICAL LAB SCIENTIST
MLS ASCP CM
The technique that involves passaging, freezing, and thawing cultured cells
CELL-CULTURE
THE TEAM WITHIN THE DRUG SPONSOR THAT HANDLES FDA SUBMISSIONS
REGULATORY AFFAIRS
An aspect of QA that ensures products are consistently produced and controlled by a set of standards
GMP
These cells are used for personalized medicine to treat degenerative diseases
INDUCED PLURIPOTENT STEM CELLS (iPSCs)
These are measured through blood, tissue, or even breath
The technique required to perform cell-culture on stem cells
ASEPTIC TECHNIQUE
The most common regulatory pathway for IVDs in the US
510(k) PREMARKET NOTIFICATION
These bridge the gap between lab research and large-scale production
PILOT PLANT MANUFACTURING
These innate immune cells are used in cancer therapy
NATURAL KILLER (NK) CELLS
Typically used in drug discovery research, this can be used to measure cell health, viability, proliferation, migration, invasion, chemotaxis, apoptosis, angiogenesis, oxidative stress, cell signaling and live cell analysis
CELL-BASED ASSAYS
The most rigorous regulatory pathway that requires extensive preclinical and clinical data demonstrating safety, efficacy, and quality
NEW DRUG APPLICATION (NDA)
A crucial process between a drug developer and CDMO that enables successful manufacturing
TECH TRANSFER
These cells actively seek out and bind to cancer cells, unleashing powerful toxins to destroy the cancer cells
CAR T cells
This technology enables a data-driven approach to developing multi-cancer early detection (MCED)
AI/ML
Steps taken to improve an assay's precision and reproducibility
ASSAY OPTIMIZATION
THIS FDA DESIGNATION PROVIDES INCENTIVES FOR DEVELOPING DRUGS FOR RARE DISEASES (AFFECTING <200K PEOPLE IN THE US), INCLUDING TAX BREAKS, EXTENDED MARKET EXCLUSIVITY, AND EXPEDITED REVIEW
ORPHAN DRUG
These systematic checks monitor critical parameters like cell viability, protein expression levels, and purity
IN-PROCESS CONTROLS (IPCs)
Scientists engineer these as a way to deliver therapeutic genes into cells to treat various diseases
Adeno-Associated Virus or AAV
A type of IVD that is designed, manufactured, and used within the same laboratory and doesn't go through the same rigorous premarket approval process by the FDA
LABORATORY DEVELOPED TEST (LDT)
This assay can be used to detect antibodies, tumor markers, and even help screen drug candidates
This landmark legislation formally established the Food and Drug Administration, consolidating regulatory authority over food and drugs previously scattered across different departments
PURE FOOD AND DRUG ACT (1906)
This instrument is used in release testing to check for purity, potency, and safety
HPLC
These target T cells through specific interactions with molecules on the cell surface
LIPID NANO-PARTICLES (LNP)