Articles in this Issue
CPI Biologics, in collaboration with Cytiva, SCIEX, BiologIC Technologies, and Biopharm Services, have developed a bench-scale demonstration of continuous processing that operates from the perfusion bioreactor through the ...
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The pivotal role of human behavior in aseptic operations cannot be overstated, as it significantly influences the safety and efficacy of sterile drug products. This article delves into the incorporation of human factor principles ...
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The recent increase in the development of adenovirus-associated virus (AAV) based gene therapies has created a large demand for the analysis of AAV-based drugs for the determination of percent empty and percent full capsid as part...
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Worldwide, precision medicine treatment spending was almost $32 billion in 2022. By 2027, that number is expected to reach more than $124 billion. This increase underscores the growing emphasis on providing more personalized ...
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The industry has many tools available to deliver medicines, although there is certainly still a significant unmet need. There are essentially three main barriers to achieving high oral bioavailability, and hence achieving ...
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Despite advances in biotechnology, there are still more than 7,000 diseases today with no effective treatment. There also continue to be disparities in global health as treatments for many infectious diseases do not attract ...
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Using isolators for aseptic processing is fast becoming standard practice in the pharmaceutical industry. However, it is a well-known fact that the transfer of equipment and materials into and out of RABS and isolators is one of ...
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Over the last forty years technologies for the aseptic production of sterile products have advanced significantly. Where staffed clean rooms once provided most of the operational capacity, new production means have been gradually ...
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The pharmaceutical industry is a dynamic and rapidly evolving field, with data integrity and rapid microbial methods (RMMs) playing pivotal roles in shaping the future of microbiology labs. These elements are not just integral to ...
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Disinfectant efficacy testing is performed to qualify a wet contact time for disinfectants for use within classified areas of aseptic manufacturing facilities (e.g., Biopharma, Pharma, Medical Device, etc.). Disinfectant efficacy ...
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As we continue to discover new and innovative small molecules and therapeutic compounds, over 80% of those candidates in drug pipeline are challenging to development due to their poor solubility and bioavailability.
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Over time, humans’ fingernails and toenails have evolved from claws to what they are now. It is believed that human ancestors utilized claws to grab onto things, dig holes, and climb tree trunks. However, as they grew larger, ...
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In recent years, transformative strides in the treatment of sickle cell disease (SCD) have materialized with the FDA’s approval of groundbreaking cell-based gene therapies. Notably, in December 2023, the FDA granted approval for ...
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Too often, the traditional document-centric approach for solving regulatory compliance issues taken by pharmaceutical companies creates barriers in terms of efficiency, collaboration, and compliance.
Because pharma is one of the...
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The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in December 2023.
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In the simplest of definitions, to “Pay it Forward” means “respond to a person's kindness to oneself by being kind to someone else.”
This can take many forms – from holding the door open for the person behind you as the person ...
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