ARTICLES BY TIM SANDLE

• EMA Issues Paper On Qualifying Non-Mutagenic Impurities For Drug Toxicological Safety

  2/28/2025

  There has been limited guidance for assessing new or elevated impurity levels. To address this, the EMA has issued a "reflection paper" to consider what is needed for a safety evaluation and how to make assessments. The public comment period ends April 30.

• 5 Characteristics Of Forward-Thinking Microbiology Labs In 2025

  12/6/2024

  Improving microbiology laboratory efficiency is a continuum. Here are five tech-forward trends that will impact cost and efficiency in 2025.

• EMA Issues New Draft Guideline: Chemistry Of Active Substances

  9/3/2024

  The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

• ChatGPT-4: Practical Applications For The Biopharma Laboratory

  7/3/2024

  AI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver?

• EMA Updates Guidance On Inhalation And Nasal Product Quality

  5/29/2024

  The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.

• Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations

  5/6/2024

  Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

• AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance

  4/8/2024

  The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.

• FDA Issues Draft Guidance For Cell & Gene Therapy Potency Assurance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  The FDA recently released a draft guidance, Potency Assurance for Cellular and Gene Therapy Products. This article summarizes the draft guidance.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.

• 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.

• Using Automation For Antimicrobial Screening

  10/5/2023

  A major challenge with antimicrobial drug development is the necessity to test millions of drug compounds in the hope of finding one that will kill a given microbial pathogen. Laboratories are using robotic machines and automated solutions to try growing previously unculturable organisms that might be sources of antimicrobial compounds — and these efforts are finding success.

• New ISO 14644-21:2023 Addresses Reducing Sampling Errors With Airborne Particle Counters

  9/11/2023

  The new ISO 14644 Part 21 addresses optimizing particle counter accuracy in cleanrooms, focusing on reducing sampling error and particle loss. Discussion includes the use of airborne particle counters, tubing, and isokinetic probes.

• CGMP Requirements For Automated Facility Monitoring Systems

  8/15/2023

  To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.

• FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity

  7/18/2023

  The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

• Key Considerations In Selecting A Robotic Solution For Endotoxin Testing

  7/6/2023

  The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

• FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors

  5/23/2023

  An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.