Search results for " safety" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
The manufacture of biopharmaceuticals presents some unique challenges when ensuring product quality and patient safety. Analytical testing can provide the data needed to produce a safe and effective d…
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Manufacturers Struggle with Breakthrough Drug Development
The regulator understands that evaluations based on limited stability data and provisional specifications could mask safety issues and that permitting manufacturers to shift more CMC analysis and fina…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As this new class of biologic medicines is introduced into healthcare systems worldwide, there must be an uncompromising commitment to patient safety, which starts with high regulatory approval standa…
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Essentials in Quality Risk Management
…tion, analytical method, and associated process changes are understood and managed to ensure patient safety and drug efficacy. An effective QRM process can further ensure the high quality of the drug…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
…g more stringent impurity level targets than exist now because the technology is more mature and the safety and efficacy is well established. For example, early mAbs had levels of high molecular weig…
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Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
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Considerations in depth filter scale-up
This data will help process development scientists and engineers understand the structure of these devices, what parameters to focus on during development, and how to set appropriate safety factors du…
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Introducing the VH3 ligand ELISA kit
Ensuring the safety and efficacy of antibody-based therapeutics is crucial in biotherapeutic manufacturing. Accurate testing for ligand leakage from affinity resins is a key part of this proce…
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Purification strategies for antibody-derived entities: bispecifics and fragments
The safety and efficiency requirement of conventional mAb processes are key also for antibody variants. Here we present strategies for purifying bispecific antibodies and antibody fragments having the…
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Getting your investigational drug regulatory ready
From the submission of an investigational new drug (IND) application, regulators will want to see a purposeful plan to assess drug safety, quality, and efficacy over time. In this article, we outline …