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Two-Component Regulatory Systems in Microbial Pathogenesis
Bacteria would adapt to ever-changing multifaceted environments. Two-component systems (TCSs) are predominantly used by bacteria to respond to...
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Nasal Drug Delivery System: Regulatory Perspective
Drugs administered intranasally are a viable alternative to parenteral delivery. The nasal route could be a viable option for medicines with low oral...
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Regulatory Aspects of Cultivated Meat
Cultivated meat is among the most disruptive, innovative alternatives to meet the growing global demand for food. Historically, regulators have...
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Regulatory Pathways Impacting Biopharmaceuticals
To obtain market approval from a regulatory authority for a new medicine, manufacturers must first initiate and then complete human clinical trials....
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Transgene Expression and Transposition Efficiency of Two-Component Slee** Beauty Transposon Vector Systems Utilizing Plasmid or mRNA Encoding the Transposase
The use of two-component transposon plasmid vector systems, namely, a transposase construct and a donor vector carrying the gene of interest (GOI)...
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Expression, Purification, and Characterization of the Recombinant, Two-Component, Response Regulator ArlR from Fusobacterium nucleatum
Fusobacterium nucleatum is associated with the incidence and development of multiple diseases, such as periodontitis and colorectal cancer (CRC)....
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Risk Management of the Minimum CMC Regulatory Compliance Continuum
The challenge of control of the biopharmaceutical manufacturing process coupled with the complexity of the resulting biopharmaceutical products...
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Nanotoxicological Issues in Agriculture and Related Regulatory Framework
The increased application of nanomaterials (NMs) in the agri-food system has been a matter of concern in recent years, which calls for the design of...
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Strategic CMC-Focused Interactions with Regulatory Authorities
The development, design and control of a biopharmaceutical manufacturing process to obtain product of required quality, safety and efficacy, has...
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Outer Membrane Channel Protein TolC Regulates Escherichia coli K12 Sensitivity to Plantaricin BM-1 via the CpxR/CpxA Two-Component Regulatory System
Plantaricin BM-1, a class IIa bacteriocin produced by Lactobacillus plantarum BM-1, has significant antibacterial activity against Gram-positive and...
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Deciphering the pathway-specific regulatory network for production of ten-membered enediyne Tiancimycins in Streptomyces sp. CB03234-S
BackgroundThe anthraquinone-fused 10-membered enediynes (AFEs), represented by tiancimycins (TNMs), possess a unique structural feature and promising...
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An Overview of Developments in Stability-Indicating Chromatographic Methods: an Essential Part of Regulatory Considerations
AbstractThe basic objectives of stability-indicating analytical methods are to provide information about the test settings and to establish the...
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Functional investigation of AfsKRS regulatory system for pristinamycin biosynthesis in Streptomyces pristinaespiralis
Three genes encoding AfsK, AfsR, AfsS homologues in Streptomyces pristinaespiralis were studied, respectively, to investigate regulatory role of...
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Regulatory Aspects and Barriers in Using Groundbreaking Technologies
New scientific discoveries and technological applications have been deeply influencing both the R&D and manufacturing of healthcare products,...
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Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs
Regulatory compliance is essential for patient protection, and it applies both to Clinical as well as to Chemistry, Manufacturing & Controls (CMC)....
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Research advances in the identification of regulatory mechanisms of surfactin production by Bacillus: a review
Surfactin is a cyclic hexalipopeptide compound, nonribosomal synthesized by representatives of the Bacillus subtilis species complex which includes B....
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Transcription Factors and Their Regulatory Role in Plant Defence Response
Plant diseases critically affect the growth and productivity with an eventual impact on global economy, food safety, and security. The regulation of...
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Management of ROS and Regulatory Cell Death in Myocardial Ischemia–Reperfusion Injury
Myocardial ischemia–reperfusion injury (MIRI) is fatal to patients, leading to cardiomyocyte death and myocardial remodeling. Reactive oxygen species...
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Role of a Two-Component Signal Transduction System RspA1/A2 in Regulating the Biosynthesis of Salinomycin in Streptomyces albus
The two-component system “AfsQ1/Q2” plays a crucial role to activate the production of antibiotics ACT, RED, and CDA through directly binding the...
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Biosensors: Ethical, Regulatory, and Legal Issues
The highest attainable standard of health is a fundamental human right as envisaged in important international human rights instruments. Biosensors...