Biosimilar Manufacturing solution center
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Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD
7/30/2024
The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.
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Scaling Up The Learning Curve For Large-Scale AAV Manufacturing
7/26/2024
The complexity of manufacturing AAV products, coupled with the challenges linked to controlling their costs, underscore the importance of improving the efficiency and scalability of these processes.
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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
7/25/2024
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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Is Your Lab Ready For A LIMS Implementation?
7/25/2024
Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.
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The Scalability Of Depth Filters For CHO Cell Culture Clarification
7/19/2024
Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.
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5 Recommendations To Maximize CSV/CSA Outcomes
7/17/2024
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
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Bacterial Endotoxin Testing, Part 1: Overview
7/16/2024
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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CAR T Set The Pace So All Can Win The Cell Therapy Race
7/15/2024
Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.
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Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret Weapon
7/11/2024
The current geopolitical climate is leading drug developers to consider global manufacturing partnerships strategically. Identify a CDMO partner that will help protect your IP, save money, and mitigate risk.
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TFF Cassettes With 100 kDa Membranes For RNA And LNP Applications
7/3/2024
This study showcases the performance of regenerated cellulose flat sheet membranes with a 100 kDa molecular weight cutoff for UF/DF of RNA molecules by TFF.