Search results for " drug"
Article
Best Practices in Qualification of Single-Use Systems
Figure 1 depicts a typical monoclonal antibody (mAb) drug manufacturing process. Single-use bioreactors are widely used in cell line expansion, and the use at production scale is increasing, notably i…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…Zeneca: We often use a modified version of the FMEA tool, similar to what is published in Parenteral Drug Association (PDA) Technical Report (TR) 44 and PDA TR 54 (for biopharmaceuticals) (3, 4). An …
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expected to be launched in the next few years as patents on key drugs, such as infliximab (Remicade…
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Biotechnology Innovation and Growth in Israel
Key regulatory considerations
New drugs registered in Israel, including biologics, must meet European Union (EU) standard GMPs in terms of quality and efficacy to ensure public safety. In ad…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
…gen peroxide, vaporous peracetic acid, or ethylene oxide) is preferred, but it is only applicable to drug substances that remain stable under the harsh conditions involved. For most biologics, theref…
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Genetic Vaccine Platforms Demonstrate Their Potential
“Such capacities may be limited worldwide, especially in pandemic situations, and facilities that are usually used for the manufacturing of ‘normal’ drug products cannot be used. Moreover, the virus p…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Stoll adds that some product-dedicated equipment must also be installed, in particular chromatography columns with packed resin for drug substance purification. “All these activities may potentially b…
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Emerging Therapies Test Existing Bioanalytical Methods
Specialty assays used to understand the distribution, function, efficacy, and immunogenicity of gene- and cell-therapy drugs—including cell-based neutralizing assays, qPCR, flow cytometry and enzyme-l…
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CDMOs Driving Emerging Bio/Pharma Success
… small molecule and monoclonal antibodies being augmented by highly potent small molecules, antibody drug conjugates, and gene and cell therapies
• A favorable regulatory environment that offe…
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Reducing Cross-Contamination Risks in Process Chromatography
Today, single-use bioreactors are widely used for biologic drug manufacturing, and downstream disposable technologies for commercial-scale production operations are being introduced and increasingly a…