Downloads

51. Trends In FDA FY2023 Inspection-Based Warning Letters 2/13/2024

    The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.

52. FDA Issues Final Guidance: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene 2/6/2024

    Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products.

53. Tangential Flow Filtration 101 — The Tech, The Need, And The Market 1/26/2024

    Here's a high-level summary of what is increasingly becoming an essential part of the downstream bioprocessing production line.

54. FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance 1/25/2024

    The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance. The public comment period ends March 27, 2024.

55. Animal Testing Isn't Perfect. Is There An Alternative? 1/8/2024

    Statistics have been showing that rodent and non-rodent experiments predict human toxicity in only 48-71% of drugs. The FDA Modernization Act 2.0 of 2022 permits the use of suitable animal-free new approach methodologies, and the European Parliament launched a program to eliminate animal studies "as soon as scientifically possible." Let's take a data-driven, research-driven look at the topic.

56. 4 Strategies To Formulate Poorly Soluble APIs 12/18/2023

    One of the toughest challenges facing small molecule drug development today is poor solubility of the API. No single technique has universal application, so several strategies exist. This article examines four notable strategies.

57. Best Practices For Preformulation In Drug Development 12/14/2023

    Preformulation testing encompasses all studies performed on a new drug compound in order to produce useful information for subsequent formulation of a suitable drug dosage form. There is preformulation across the stages of drug discovery, early development, and late development. The route of administration dictates what is important.

58. Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices 12/11/2023

    The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.

59. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

    In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

60. Designing Facility Monitoring Systems For Cleanrooms 12/4/2023

    Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.