Biosimilar Manufacturing solution center
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FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals
9/11/2024
The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.
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Wish SUS Cost Less? Survey Says Your Peers Do, Too
9/6/2024
BioPlan Associates 21st Annual Report found biopharma companies want lower cost single-use system options over any other new product development area.
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A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions
8/30/2024
Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.
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The Role Of Extractables Data In The Adoption Of Single-Use Systems
8/29/2024
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
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Drug Product Formulation & Process Development: The Must-Have Skills At A Glance
8/26/2024
Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.
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Should You Be Using Unique Container Identification?
8/22/2024
Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.
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The Influence Of Flows In cGMP Architectural Design
8/22/2024
In drug manufacturing facility layout, balancing the roles of layout and procedure plays a critical role. This article examines how the interplay may be resolved, and how this resolution affects facility layout during design.
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Are You Taking The HPCs In Your ADCs Seriously?
8/16/2024
The wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design.
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NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level
8/16/2024
Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations.
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Optimizing Virus Bank Manufacturing
8/16/2024
Gain insight into two cases where clients were enabled to overcome obstacles during virus bank manufacturing.