White Papers
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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.
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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.
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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.
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PBPK Modeling For Optimized Controlled Release Formulation 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.
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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.
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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 additional insights. Discover how cell therapy manufacturers can combat these costs.
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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.
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Inspection Of Injectable Products For Visible Particulates
8/8/2023
Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.
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Critical Considerations For Buffer Preparation
8/7/2023
Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and other related buffer use topics.
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Topliss Sets In Drug Design Technical Notes For The Medicinal Chemist
8/3/2023
When considering new, innovative, and efficient drug design processes, you may want to review Professor J G Topliss's non-mathematical operational schemes for analogue design.