To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
- 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
- Continuous Manufacturing: Many Want It, But Here’s Why Few Have It
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.
Continuous Manufacturing: Many Want It, But Here’s Why Few Have It
In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.
BIOSIMILAR WHITE PAPERS
COGs Process Economics For Autologous Cell Therapy
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.
Quantitation Of Monoclonal Antibodies In Serum2/8/2024
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
Sterile Filtration And Quality Risk Management8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
The Dynamic Regulatory Environment Of Drug-Device Combination Products11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
How Can The Industry Drive Down The Cost Of Viral Gene Therapies?4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
Regulatory Considerations For Alternative Microbial Methods2/28/2022
We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.