Featured Pharma Online Editorial

  1. Addressing Blind Spots In Assuring Therapeutic Equivalence 1/14/2025

    The new FDA commissioner-designee's focus offers a timely opportunity to expose root causes to distinguish between "special" and "common" causes of deviation and variability in public health and regulatory oversight.

  2. Can Our Current Operational Processes Survive In 2025 And Beyond? 12/19/2024

    As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?

  3. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

  4. FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics 12/11/2024

    FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.

  5. 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.

  6. Bayer's Supply Network-Centric Approach To Digitalization 12/5/2024

    Shifting away from paper records is the nonnegotiable first step toward implementing novel technology. Here's how one company is approaching the monumental task.

  7. Oral Solid Dosage Formulation And Process Development: A Case Study 12/4/2024

    This case study involves a drug substance currently in the preclinical phase. Discussion includes API physical chemical characteristics, enabling technologies, formulation assessment, and more.

  8. AstraZeneca's Digitally Connected Strategy For API Manufacturing 12/3/2024

    The company's packing in the latest technology at its APICOM facility in Dublin. A key feature is more effective and timely use of process data.

  9. 2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality? 12/3/2024

    The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.

  10. Enteric Coatings For Oral Solid Dosages: A Short Guide 11/19/2024

    Enteric coatings play a pivotal role for drugs/APIs that need to withstand the harsh conditions of the stomach in order to dissolve in the intestine. This article shares an overview, commonly used excipients, and more.