ARTICLES BY TIM SANDLE

• EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class

  6/23/2026

  The European Medicines Agency’s Guideline on the Development and Manufacture of Synthetic Peptides, adopted in Dec. 2025 and effective from June 1, 2026, is an important regulatory development for peptide manufacturers.

• Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline

  4/28/2026

  The EMA's December 2025 draft guideline on expectations for the quality documentation of radiopharmaceuticals replaces the earlier 2007 guideline and reflects significant developments.

• Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

  3/17/2026

  A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

• FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs

  12/11/2025

  The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

• 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.

• Enhanced Risk? EMA Issues New Guidance For OSD Co-processed Excipients

  10/9/2024

  In recent years, there has been a drive toward the use of co-processed excipients to aid leaner manufacturing. This has prompted the European Medicines Agency (EMA) to develop a new guidance document, Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V). The public consultation period is open until the end of 2024.

• 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.