Search results for " safety"
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use in assessing the safety, effectiveness, quality, and performance of products.…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
…al and overarching, and adherence to strict quality standards is essential to ensure consistency and safety for patients.
Scaling considerations
Scaling itself does not necessarily increase the…
Article
Gene Therapies Push Viral Vector Production
“For lentiviral packaging, there are iterative cycles of safety improvements. Agilent vectors, for example, are suitable and compatible with generation-four packaging systems (i.e., the latest version…
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An Analytical Approach to Biosimilar Drug Development
By Feliza Mirasol
The long-term safety and efficacy of biosimilars are largely based on clinical studies that have already been conducted on the reference biologic, but these studies may…
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Evaluating E&L Studies for Single-Use Systems
Regulatory guidelines require that the product contact items “shall not be reactive, additive, or absorptive” to assure drug product quality and safety (2). The manufacturer is, therefore, responsible…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
…eutical or reference product to which biopharmaceuticals will have to show comparability in quality, safety, and efficacy to be approved as biosimilars.
Revised guidelines on general principle…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
QTPP is defined in ICH Q8 (R2) as "a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and ef…
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Putting Viral Clearance Capabilities to the Test
Bergmann, manager, viral safety and clearance services, Eurofins Lancaster Laboratories. “The key parameters that determine the scope of the study are the clinical stage and indication of the product …
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Cleaning in the GMP industry is a critical process intended to prevent or, in more modern terms, reduce risk of contaminating the subsequent product with undesirable residues that may impact patient s…
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Innovative Therapies Require Modern Manufacturing Systems
Most of its $132 million budget increase goes to expanding food safety programs, but small amounts are allotted to ensuring the accuracy of genetic tests important to precision medicine, expanding for…