Search results for " efficacy"
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Advances in Engineering of Protein-Based APIs
Fully human mAb therapeutics with fully human sequences have reduced immunogenicity potential and improved safety and efficacy, enabling chronic treatment without liabilities, according to Jennitte St…
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Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities and their consequence to the ultimate quality, safety, and efficacy of biopharmaceuticals--as well as improvements in analytical technology that provide…
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mAbs to Watch in 2016
Although the company will first seek an approval for the medication for the treatment of eosinophilic asthma, it is also researching the drug’s efficacy in the treatment of eosinophilic esophagitis. R…
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Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
In 2012, the EMA also published final guidance, the non-clinical and clinical requirements for biosimilar mAbs, including information on pharmaco-toxicologic, pharmacokinetic, pharmacodynamic, efficac…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
…eference product to which biopharmaceuticals will have to show comparability in quality, safety, and efficacy to be approved as biosimilars.
Revised guidelines on general principles
In i…
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Regulatory Challenges in the QbD Paradigm
The key steps for QbD implementation include: identification of the product attributes that are of significant importance to the product's safety or efficacy (i.e., target product profile and critical…
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EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The paper will address options for introducing a new strain into an existing approved vaccine; the minimal regulatory requirements for quality, safety, and efficacy; and bridging studies required to p…
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Biosimilar Quality Requirements
To demonstrate interchangeability, a sponsor typically sets up switching studies to show that the risk of safety of diminished efficacy from switching between the proposed interchangeable product and …
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Scalable Viral Vector Manufacturing
The interest for robust and scalable viral vector manufacturing is rapidly increasing, with the recent developments of both cell and gene therapy and oncolytic virus-based therapies. As cost pressur…