Industry Insights

1. Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3 12/20/2023

   This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.

2. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

   The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

3. A Custom Path To The Clinic: Inside A Collaborative Model 6/19/2026

   Balancing speed, compliance, and control is no small task. A different approach to external support is emerging—one that prioritizes knowledge transfer, collaboration, and long-term confidence.

4. Balancing Timelines In Outsourced R&D With GXP Compliance 5/27/2026

   Outsourced R&D balances speed and quality by integrating strong governance, clear planning, and GXP compliance, enabling efficient execution while reducing risk, rework, and development delays.

5. Optimizing Drug Discovery And Development Collaborations 8/15/2023

   As demand for more precise, tailored CRO services grows, so does the emphasis drug developers place on their partners’ flexibility, agility, and enthusiasm for collaboration.

6. How Recent Trends Impact Bringing Your Molecule To Market 7/9/2024

   With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

7. The Current Landscape Of mRNA Vaccines In Clinical Research 3/17/2022

   With the Pfizer-BioNTech and Moderna products, mRNA vaccines made global headlines in 2021 in the fight against COVID-19. As we recognize National Immunization Awareness Month, this article shares how mRNA vaccines currently in clinical research and clinical trials may be soon used to fight HIV-1, herpes, cancer, and more.

8. Formulation Development Experience For Effective Particle Identification 1/14/2026

   Combining advanced analytics with deep formulation knowledge enables precise root-cause analysis, preventing manufacturing delays and ensuring that products remain high-quality and safe for patients.

9. 5 Promising Applications Of RNA Therapeutics 7/28/2023

   Ribonucleic acid (RNA), once considered a mere messenger molecule, has now emerged as a versatile tool in the development of novel therapies. In this article, we will delve into the world of RNA therapeutics, exploring their potential and five applications that could impact the future of medicine.

10. Top 10 Inspection Findings From FDA, MHRA, Russia's Ministry Of Health 10/7/2020

    Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.