Month: December 2025
How to Get FDA Approval: Navigating Regulatory Compliance
FDA approval for drugs and biologics is not a single event, but a regulated process that spans development, manufacturing, and post-market oversight. Approval decisions are based on the cumulative evaluation of scientific data, manufacturing controls, and ongoing compliance with applicable FDA requirements. For organizations developing regulated products, understanding how these elements interact helps frame regulatory ... How to Get FDA Approval: Navigating Regulatory Compliance
What Is Plasmid DNA? Understanding Its Role in Biotechnology
Plasmid DNA is a small, circular, double-stranded DNA molecule that exists independently of the main bacterial chromosome and replicates autonomously using host cellular machinery. Plasmids often carry genes that confer selective advantages—such as antibiotic resistance or metabolic capabilities—but are not required for basic cellular survival. Plasmid DNA differs from chromosomal DNA in several important ways: Functional role: Chromosomal ... What Is Plasmid DNA? Understanding Its Role in Biotechnology
What Is ISO/IEC 17025? A Guide to Laboratory Accreditation
ISO/IEC 17025 is an international standard that defines the competence requirements for testing and calibration laboratories. It is sometimes described as a “certification,” though it formally establishes laboratory accreditation based on demonstrated technical competence. Laboratories accredited to ISO/IEC 17025 operate under a quality management system designed to support impartiality, traceability, and ongoing compliance. The standard ... What Is ISO/IEC 17025? A Guide to Laboratory Accreditation
What Are Advanced Therapeutic Medicinal Products (ATMPs)?
Advanced Therapeutic Medicinal Products (ATMPs) are a class of therapies that include gene therapy, somatic cell therapy, and tissue-engineered products. Designed to repair, replace, or modify biological functions at their source, they differ from traditional medicines that primarily manage symptoms. For researchers, quality teams, and regulatory professionals, understanding how ATMPs are defined, classified, and evaluated helps support development, ... What Are Advanced Therapeutic Medicinal Products (ATMPs)?
Guide to USP ‹661› Series for Plastic Packaging
Pharmaceutical packaging directly influences the safety, stability, and overall performance of drug products. The USP <661> series defines how plastic materials and packaging systems must be evaluated to confirm that they are appropriate for pharmaceutical use. For quality, regulatory, and product development teams, the standard is a key reference for: identifying packaging-related chemical migrants, assessing how materials interact ... Guide to USP ‹661› Series for Plastic Packaging
How to Calculate Endotoxin Limits
Endotoxin contamination remains a major quality concern in pharmaceutical and medical device production. Unlike sterility testing, which verifies the absence of viable microorganisms, endotoxin testing targets pyrogenic substances that remain even after sterilization. These lipopolysaccharides are heat-stable and difficult to remove once present. For manufacturers, knowing how to calculate endotoxin limits and applying validated test methods are necessary steps to meet global regulatory expectations ... How to Calculate Endotoxin Limits
What Is Raw Material Testing? Standards for Quality Assurance
Raw material testing is the process of verifying the identity, purity, composition, and quality of materials before they are used in pharmaceutical or medical device manufacturing. In regulated environments, these evaluations confirm that incoming materials meet predefined specifications and are suitable for cGMP- or quality-system–controlled production. For pharmaceutical manufacturers, raw material testing supports: confirmation that ingredients ... What Is Raw Material Testing? Standards for Quality Assurance
What Is Gene Therapy?
Gene therapy is a treatment approach that modifies, replaces, or regulates genes within a patient’s cells to address the underlying cause of disease. Instead of targeting symptoms, these therapies work at the molecular level by: replacing a nonfunctioning or mutated gene with a functional copy, inactivating a gene that is producing harmful effects, or introducing a ... What Is Gene Therapy?