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 FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance 1/25/2024

    The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance.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.

42. 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.

43. 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.

44. 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.

45. 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.

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 FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

    In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is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.

47. 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.

48. A Brief Introduction To Environmental Monitoring For Startups 11/17/2023

    Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.

49. Why Lactococcus Lactis Might Be The Best Membrane Protein Factory 11/17/2023

    The bacteria lactococcus lactis has emerged as a promising alternative expression system for membrane proteins, which are difficult to manufacture. L. Lactis is inexpensive and easy to grow. It also doesn't produce endotoxins, which makes it a good fit for therapeutic applications.

50. Liquid Biopsy: The Next Evolution In Personalized Prostate Cancer Screening 11/7/2023

    The prostate-specific antigen (PSA) blood test has long been the gold standard in prostate cancer diagnostics. More recently, liquid biopsy, which includes the analysis of circulating tumor material in the blood or urine, has emerged as a promising non-invasive tool.