Articles in this Issue
The principal advantage of the three different filtration/separation techniques is that the operation is achieved without change or interphase transfer, thus any desired product is continually maintained in an aqueous environment....
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In the absence of definitive guidance on microbial testing in R&D and Marketed Product Stability Programs for Drug Substances and Drug Products, the pharmaceutical industry makes inconsistent and sometimes misguided choices with ...
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Rare diseases present substantial challenges in terms of diagnosis and care navigation. For 25% of patients, obtaining an accurate diagnosis can take an average of five to seven years from the onset of the disease, necessitating ...
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Aseptic manufacturing is changing. Regulations like the EU GMP Annex 1 encourage modernization. Technologies such as gloveless isolators and single-use systems that automate processes and limit human interventions are becoming the...
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Every day counts for manufacturers of short-shelf-life biologics/treatments who need to release their products and have them administered to patients as fast as possible. This is particularly the case for biologics as well as cell...
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Absorption, distribution, metabolism, and excretion (ADME) studies are a critical component of preclinical drug discovery, providing important insights into the pharmacological properties of a drug, including indicators of a drug ...
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Pharmaceutical formulation refers to the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. This process is vital, as it can influence a drug’s efficacy, ...
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Over 80% of new molecular entities (NMEs) are poorly soluble, often making it impossible to formulate them using conventional technologies, such as micro-milling, salt formation, or complexation. That has triggered a range of ...
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The world of healthcare and technology are undergoing a period of rapid transformation especially when it comes to evolving regulatory compliance requirements for medical devices. On one hand advancements in medical technology, ...
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In a 2022 life sciences industry report,1 70% of biopharmaceutical professionals indicated a maturity gap in the efficiency of safety signal analytics processing. Transforming signal detection, as well as signal validation, in ...
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Underpinned by universal risk-management and scientific principles, QbD’s systematic approach enhances product quality and predictability. For pharmaceutical professionals, embracing it has become a strategic necessity.
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Time matters. Everyone in pharmaceutical manufacturing is busy, making it imperative to find better monitoring tools. In particular, bioburden monitoring and bacterial endotoxin testing (BET) are areas in need of improvement.
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As scientific research into new treatments continues to grow, the need to effectively test and contain infectious agents is increasingly becoming a top priority.
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In August 2023, the revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products came into force, with implications for contamination control strategies and, by extension, for plant facilities, ...
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Microbial environmental monitoring (EM) is a semi-quantitative assessment that is extensively limited by method, sample size, technical variables, and biological variables. EM action level or out of trend excursions should be ...
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The pharmaceutical packaging industry is facing increasing pressure to adopt more sustainable practices and to use more sustainable materials. This is in part due to the carbon footprint of pharmaceutical packaging, which is ...
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In today’s life science industry, the adoption of digital technologies for greater efficiency and compliance has become commonly accepted, whether it is the patient using apps and wearables that report data to healthcare providers...
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Biopharmaceuticals have greatly increased in the market year over year with current analysis indicating an increase in the range of 8-15% during the rest of the decade. As biopharmaceutical products are coming off patent, ...
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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 August-September, 2023.
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Have you ever had the feeling you were heading too fast towards something that was inevitable?
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