White Papers

  1. Purity Analysis Methods For Synthetic Prime Editing Guide RNAs 9/8/2023

    Develop a fast, easy workflow for the purity analysis of complex pegRNA molecules along with a robust denaturing technique for pegRNA with high levels of secondary structure.

  2. RFID-Based Unit-Level Traceability: Could It Be The Key To Operational Excellence For Fill-Finish Lines? 9/5/2023

    Radio frequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

  3. Single-Use vs. Stainless Steel Debate In Biopharmaceutical Manufacturing 9/1/2023

    Investigate the advantages and disadvantages of single-use technologies and stainless steel systems with a focus on performance, adaptability, and economics.

  4. Comparing Single-Use To Fixed Bioprocessing Systems 9/1/2023

    Several life cycle assessments have been conducted comparing the environmental impact of SUTs to conventional fixed systems, leading to results that could inform changes in bioprocess system use.

  5. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  6. Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization 8/25/2023

    There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.

  7. PBPK Modelling For Optimizing Controlled Release Dosage Form Development 8/24/2023

    Examine the benefits of controlled release, the application of PBPK modeling in controlled release formulation development, and how modified release products can be developed to deliver optimal patient outcomes.

  8. Recommendations For Successful IND Approval Of RNA-LNP Drugs 8/22/2023

    The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.

  9. COGs Process Economics For Autologous Cell Therapy 8/11/2023

    Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how cell therapy manufacturers can combat these costs.

  10. The State Of Plastics Recycling In BioPharma 8/9/2023

    Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.