Featured Editorial
-
5 Keys to Supplier/Purchasing Controls – And Product Quality
10/1/2024
The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Every drug device combination product will utilize third parties for various services, constituent parts, or other components. In this article, Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.
-
Improving Medical Device Testing With Robotic Automation
9/25/2024
Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in verification testing can help with regard to precision, efficiency, and more.
-
Araris Doubles Down With Dual-payload ADC
9/24/2024
Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.
-
Are You Compliant? States Are Issuing New Regulations For IV Therapy Compounding
9/13/2024
The regulatory environment surrounding IV therapy and med spas has become fragmented. In some states, the definition of compounding has been expanded.
-
Preparing For The FDA QMSR: Will You Be Ready?
9/3/2024
The new FDA Quality Management System Regulation (QMSR) becomes effective in February 2026. In this article, Fran DeGrazio discusses the implications for combination product and medical device developers as they prepare to demonstrate QMSR compliance.
-
Drug Product Formulation & Process Development: The Must-Have Skills At A Glance
8/26/2024
Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.
-
FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
8/14/2024
The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.
-
Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection
8/7/2024
This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.
-
Takeda Cut Its PPQ Timeline With beePFS — Here's How
7/31/2024
The company broke from the norm and used a layered approach — as opposed to a linear one — to develop a new filling line for prefilled syringes of IBS therapy Entyvio.
-
Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD
7/30/2024
The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.