Article
Pharmacology & Pharmacy
Jerry Li, Mina Nikanjam, Coleen K. Cunningham, Elizabeth J. McFarland, Emily E. Coates, Katherine V. Houser, Bob C. Lin, Adrian B. McDermott, Britta Flach, Lucio Gama, Richard A. Koup, Barney S. Graham, John R. Mascola, Julie E. Ledgerwood, Edmund V. Capparelli
Summary: This study used population pharmacokinetic modeling to characterize VRC01 PK for dosing selection in pediatric patients. Results showed differences in clearance and subcutaneous bioavailability of VRC01 between infants and adults, with rapid absorption observed in infants with potential therapeutic levels reached quickly.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2021)
Review
Medicine, Research & Experimental
Eva Germovsek, Ming Cheng, Craig Giragossian
Summary: The article discusses the biology of mAbs, similarities and differences in PK processes within different species and in humans, and provides a detailed overview of allometric scaling approaches for translating mAb PK from preclinical species to human and from adults to children.
Review
Pharmacology & Pharmacy
Tridib Chaira, Chandru Subramani, Tarani Kanta Barman
Summary: The search for new drugs is time-consuming and expensive, with a significant portion of resources dedicated to generating predictive human pharmacokinetic profiles from animal data. These profiles are crucial for optimizing antiviral drug research and extrapolating human pharmacokinetic parameters from animal profiles.
Article
Medicine, Research & Experimental
Peng Zou
Summary: This study compared the performance of two allometric scaling approaches and a body-weight-based dose conversion approach for dose prediction in gene therapy. The body-weight-based approach underestimated the dose in some vectors, while the allometric scaling approach overestimated the dose. The allometric scaling between log GEF and W-0.25 was appropriate in certain conditions.
MOLECULAR PHARMACEUTICS
(2023)
Review
Biochemistry & Molecular Biology
Anne van Rongen, Elke H. J. Krekels, Elisa A. M. Calvier, Saskia N. de Wildt, An Vermeulen, Catherijne A. J. Knibbe
Summary: This review evaluates the accuracy of allometric and other pediatric clearance scaling methods and finds that there is no universal exponent that can accurately scale clearance for all drugs. Therefore, decision tables based on various factors are proposed to select appropriate methods, reducing the need for full PBPK-based clearance predictions.
EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY
(2022)
Article
Engineering, Marine
Hans Ulrik Riisgard, Poul S. Larsen
Summary: Demosponges are filter-feeding organisms composed of modular units. The filtration rate of demosponges is related to their size, but the relationship varies depending on the type of sponge. Small single-osculum sponges exhibit a scaling relation between filtration rate and volume, while multi-oscula sponges and large single-osculum sponges have different scaling relationships. The observed decline in volume-specific filtration rate from small to large sizes is discussed.
JOURNAL OF MARINE SCIENCE AND ENGINEERING
(2022)
Article
Medicine, General & Internal
Rachel A. Bender Ignacio, Kara W. Chew, Carlee Moser, Judith S. Currier, Joseph J. Eron, Arzhang Cyrus Javan, Mark J. Giganti, Evgenia Aga, Michael Gibbs, Herve Tchouakam Kouekam, Eva Johnsson, Mark T. Esser, Keila Hoover, Gene Neytman, Matthew Newell, Eric S. Daar, William Fischer, Courtney V. Fletcher, Jonathan Z. Li, Alexander L. Greninger, Robert W. Coombs, Michael D. Hughes, Davey Smith, David Alain Wohl
Summary: These two clinical trials showed that tixagevimab and cilgavimab monoclonal antibodies were safe and effective for treating early COVID-19, but did not change the time to symptom improvement. The treatment outcomes were better for the intramuscular injection.
Article
Biochemistry & Molecular Biology
Ilias Semmouri, Jana Asselman
Summary: Allometric scaling can be used to overcome limitations in metatranscriptomics and provide accurate estimations of community structure and functioning.
MOLECULAR ECOLOGY RESOURCES
(2023)
Article
Pharmacology & Pharmacy
Rachel A. Bender Ignacio, David A. Wohl, Rosalin Arends, Venkatesh Pilla Reddy, Ying Mu, Arzhang Cyrus Javan, Michael D. Hughes, Joseph J. Eron, Judith S. Currier, Davey Smith, Kara W. Chew, Michael Gibbs, Courtney Fletcher
Summary: This study evaluated the pharmacokinetics of AZD7442 in different administration routes and found that the thigh intramuscular injection had similar serum concentrations compared to intravenous injection in symptomatic adults with COVID-19. Thigh injection can provide consistent antibody exposure and improve convenience of use.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2022)
Article
Immunology
Basudev Paudyal, Adam McNee, Pramila Rijal, B. Veronica Carr, Alejandro Nunez, John McCauley, Rodney S. Daniels, Alain R. Townsend, John A. Hammond, Elma Tchilian
Summary: Prophylactic intravenous administration of specific monoclonal antibodies in pigs showed significant reduction in lung pathology and virus loads, but not consistent reduction in nasal shedding. The effect on lung pathology and virus load is consistent across different doses, suggesting that lower doses may be effective in reducing disease severity.
FRONTIERS IN IMMUNOLOGY
(2021)
Article
Biochemical Research Methods
Ce Shi, Xu-Jun Chen, Biao Jiao, Ping Liu, Shu-Ying Jing, Xue-Zhao Zhong, Ran Chen, Wei Gong, Dong-Qiang Lin
Summary: Continuous process is a promising alternative in biomanufacturing, offering higher productivity and lower material consumption compared to traditional batch processes. However, the optimization of full continuous processes is often neglected due to their complexity and interactions, which cannot be effectively addressed by traditional experiment-based methods. In this study, the process simulation tool SuperPro Designer and continuous capture chromatography model were integrated into a model-assisted design platform to develop continuous processes more effectively. The influences of different operation modes and sub-lot numbers on equipment utilization were analyzed, and the optimal combination was determined for pilot-scale production. After process optimization, the equipment utilization of continuous processes was significantly improved to 27.3%, and a pilot-scale case study validated the success of scaling up and process design. The proposed approach also showed a 17.4% cost reduction compared to batch processes, demonstrating its potential for future industrial applications.
JOURNAL OF CHROMATOGRAPHY A
(2022)
Article
Medicine, Research & Experimental
Boris Grinshpun, Nels Thorsteinson, Joao N. S. Pereira, Friedrich Rippmann, David Nannemann, Vanita D. Sood, Yves Fomekong Nanfack
Summary: Understanding the pharmacokinetic properties of drugs is crucial for evaluating efficacy. The complexity of therapeutic antibody PK is influenced by various factors, including interactions with targets and antibody intrinsic factors. Studies have shown a link between biophysical properties of antibodies and rapid clearance, highlighting the importance of early selection and optimization of antibodies for desirable pharmacokinetic profiles.
Review
Biotechnology & Applied Microbiology
Ziyu Jiang, Paul A. Dalby
Summary: Accelerating AAV manufacture to meet the demand for gene therapies is important but challenging. Quality by design ensures product quality and safety. Rapid stress tests, developability screens, and scale-down technologies can simplify AAV product and manufacturing bioprocess development, but require improved analytical methods and tools.
TRENDS IN BIOTECHNOLOGY
(2023)
Article
Chemistry, Analytical
Beijun Ang, Xinxin Xu, Liguang Xu, Liqiang Liu, Hua Kuang, Chuanlai Xu
Summary: In this study, a method combining enzymatic hydrolysis with a colloidal gold lateral flow immunoassay (LFIA) was established to detect total homocysteine (tHcy) in blood, which has the potential to predict cardiovascular risk accurately.
Article
Pharmacology & Pharmacy
Xiaoqing Fan, Wojciech Krzyzanski, Dongyang Liu, Raymond S. M. Wong, Xiaoyu Yan
Summary: Recombinant human erythropoietin (rHuEPO) is an effective drug for anemia treatment in patients with chronic kidney disease. However, EPO-resistance is a significant issue. Combining rHuEPO with romiplostim, a thrombopoietin receptor agonist, can overcome EPO-resistance.