Outsourced Pharma White Papers

1. Next Generation Sequencing In Viral Safety Testing 7/25/2025

   Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving biopharmaceutical safety and accelerating regulatory-compliant product development.

2. Leak Rate Testing for Freeze Dryers: A Scientific Approach 10/16/2024

   Explore our innovative approach to establishing leak rate acceptance criteria and ensure the integrity of your freeze-drying processes for sterile pharmaceutical production.

3. Annex 1: Sterile Fill/Finish For Early Phase Clinical Supplies 5/5/2025

   Meeting stringent requirements for sterile fill/finish operations hinges on robust contamination control strategies, advanced isolator technology, and rigorous integrity testing to ensure patient safety.

4. Accelerating ADC Clinical Development Timelines 8/28/2024

   For ADC developers, obtaining the desired payload can be a challenge, as their synthesis is more complex than most other small molecules. Learn about a more efficient approach to payload synthesis.

5. A Faster Path To Genomic Medicine Feasibility 3/17/2026

   Life Edit accelerates genomic medicine by comparing five editing modalities, engineering new enzymes, and rapidly pinpointing optimal strategies that boost feasibility, cut risk, and speed clinical progress.

6. Regulatory Considerations For Excipients Used In Lipid Nanoparticles 8/15/2024

   Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.

7. Email Etiquette That Actually Saves Time for Pharma & Biotech 5/12/2026

   Smarter email habits cut wasted time, reduce inbox noise, and improve collaboration. Clear subject lines, careful recipients, and purposeful tool use keep teams focused on meaningful work.

8. A Simple And Powerful Solution For Accelerating Dissolution 5/5/2026

   Many poorly soluble drugs fail not because of low solubility, but because they dissolve too slowly. Learn how focusing on dissolution rate can unlock absorption gains using simple strategies.

9. Developing Effective Procedures 10/21/2024

   Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

10. Solve ATMP Aseptic Filling Challenges With Gloveless Isolators 1/9/2026

    Human intervention is the top contamination risk in ATMP manufacturing. Robotic gloveless isolators address that risk through full automation and real-time monitoring during aseptic filling.