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2 weeks ago | 
biopharminternational.com | Cynthia Challener
Emerging therapies provide new approaches to the treatment of many diseases and, in some cases, the potential for real cures. However, genetic medicines, cell therapies, multispecific antibodies, and other novel modalities are highly complex and present numerous challenges to their development across formulation, manufacturing, analysis, regulatory compliance, and other activities.
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3 weeks ago | 
pharmasalmanac.com | Cynthia Challener
Why Supply Chain Resilience MattersBiopharmaceutical companies must not only develop safe and effective drugs, but ensure reliable supply of those products once they are on the market. That requires ongoing access to sufficient quantities of high-quality raw materials, manufacturing equipment, and components; continued performance of production facilities; and control over storage and distribution, with all activities meeting regulatory compliance requirements.
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1 month ago | 
pharmasalmanac.com | Cynthia Challener
Why Single-Use Technologies? Single-use technologies (SUTs) for biopharmaceutical manufacturing find applications today across all aspects of upstream and downstream processing.
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1 month ago | 
biopharminternational.com | Cynthia Challener
Addressing the challenges posed by the limited bioavailability of many small-molecule APIs and the instability and inability of nucleic acids to pass through cell membranes has become an important goal within drug development. Most efforts have focused on finding delivery systems that enhance stability and solubility, facilitate cellular entry, and ideally allow effective targeting of specific cells, tissues, and/or organs.
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1 month ago | 
pharmasalmanac.com | Cynthia Challener
Historical Focus on IP ProtectionThe birth of the pharmaceutical industry took place in Germany during the mid-19th century, with the United States becoming a major player only in the early 20th century. As the industry matured, competition became fierce, and companies took great measures to protect their research activities and proprietary product data.
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1 month ago | 
pharmasalmanac.com | Cynthia Challener
Convoluted Route to the Orphan Drug Act The first use of the term orphan in relation to drugs occurred in the United States in the 1960s and referred to drugs approved for use in adults but not children, likely due to their limited profitability in the smaller market.1 A few years later, the term orphan was applied to drug substances developed prior to passage in 1962 of the Kefauver–Harris Amendments to the Food, Drug and Cosmetic Act and for drug products that had been previously marketed...
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2 months ago | 
pharmasalmanac.com | Cynthia Challener
Potential Advantages of Continuous BioprocessingContinuous processing has been leveraged by a variety of industries for many decades, providing a considerable range of benefits, including increased productivity in a smaller footprint, greater process consistency, lower resource consumption and waste generation for reduced environmental impacts, improved quality, reduced costs, and enhanced flexibility to respond to market demands.
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2 months ago | 
biopharminternational.com | Cynthia Challener
Successful production of recombinant proteins and viruses requires use of the optimum expression system for the target product. Mammalian cell culture predominates due to its ability to produce biomolecules with post-translational modifications that closely match those of human proteins. Microbial fermentation is quicker, but mostly suited for the production of smaller molecules such as peptides and antibody fragments.
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2 months ago | 
biopharminternational.com | Cynthia Challener
Accurate and timely analytics are essential to successful development and manufacturing of biopharmaceutical products, whether they are small-molecule drugs, recombinant proteins or antibodies, or novel modalities such as cell and gene therapies. The correct choice of analytical technologies for process monitoring and optimization during process development can reduce timelines and risk while increasing the ability to develop robust, readily scalable processes.
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Dec 6, 2024 | 
biopharminternational.com | Cynthia Challener
The rapid advance of next-generation therapies, such as gene and gene-modified cell therapies and messenger RNA (mRNA)-based vaccines, through the clinical phase to market has created significantly increased demand for DNA raw materials. Plasmid DNA (pDNA) produced via fermentation in Escherichia coli (E. coli) is typically used, but supply has struggled to keep up with demand.
