Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
- Understanding And Navigating Diverse Regulatory Environments
- Developing & Implementing A Continuous Bioprocess Control Strategy
- Huh? Where Did That Environmental Monitoring Hit Come From?
- A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
- New DSCSA Guidance Details Layers Of Verification System Requirements
- Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry
- Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
Understanding And Navigating Diverse Regulatory Environments
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.
Developing & Implementing A Continuous Bioprocess Control Strategy
A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.
Huh? Where Did That Environmental Monitoring Hit Come From?
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.
A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
New DSCSA Guidance Details Layers Of Verification System Requirements
A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.
Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.
BIOSIMILAR WHITE PAPERS
Remote Access And Monitoring Of Bioprocess Unit Operations
Digital transformation projects require a scalable connectivity solution for the manufacturing floor that is easily and rapidly deployed. Explore elements that enable connectivity among equipment.
Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
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.
The State Of Plastics Recycling In BioPharma8/9/2023
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.
Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass5/12/2023
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development12/27/2023
Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
COGs Process Economics For Autologous Cell Therapy8/11/2023
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.