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Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article 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…

Article A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
The need for harmonized standards was emphasized, but lacking any immediate consensus, the panelists recommended that drug companies take a risk-based approach to evaluating single-use system componen…

Article Technologies and Practices Must Evolve to Meet Demand
3, 2014, nearly 30% of FDA’s new drug approvals for 2014 were for biologic-based therapies, up from 7% in 2013 (1). As the percentage of large-molecule drugs grows, bioprocessing capabilities must kee…

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