Biosimilar Manufacturing solution center
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Developing & Implementing A Continuous Bioprocess Control Strategy
2/20/2024
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.
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Huh? Where Did That Environmental Monitoring Hit Come From?
2/16/2024
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.
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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
2/16/2024
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.
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Using Relational Risk Analysis To Control Procedure Failures
2/15/2024
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).
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The Cure For The Cure
2/14/2024
Traditional aseptic filling solutions can introduce contamination and variability. Learn about Cytiva's commitment to finding innovative solutions and improving patient outcomes in the field of medicine.
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Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety
2/14/2024
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.
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Continuous Manufacturing: Many Want It, But Here’s Why Few Have It
2/13/2024
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.
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Trends In FDA FY2023 Inspection-Based Warning Letters
2/13/2024
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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Consolidating The Supply Chain For mRNA
2/12/2024
Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing
2/9/2024
Learn how following strict laboratory practices and conducting routine testing for Mycoplasma contamination using nucleic acid-based assays can help ensure the production of safe and high-quality biopharmaceutical products.