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FAQs

FAQs
What are Gene Therapy Products?
Nucleic acids (plasmids, RNA) that play a role by transcription or translation of transmissible genetic material, gene-modified microorganisms (viruses, bacteria, fungi) that express specific genes, in vitro gene-modified human cells, products that edit the host genome, etc.
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Demonstration Method for Control Limits of Organic Impurity
•Scientific literature and main metabolite method: If the scientific literature has proved that a certain level of an impurity is not a safety concern, then the limit established based on that level does not need further justification. In addition, if the scientific literature has proved that an impurity itself is also the main metabolite of the drug substance metabolized in the body, its safety is obvious, so even if the impurity is set a limit higher than the ICH demonstration limit, it can usually be considered that the impurity is reasonably controlled.
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What is the Main Difference Between siRNA and ASO?
The chemical structure,ASO is single-stranded, and siRNA is double-stranded.ASO either degrades target mRNA through RNase H, interferes mRNA function with steric effects or affects mRNA shearing, or acts on miRNA.siRNA degrades mRNA mainly through RISC.
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What are the Types of Nucleic Acid Drugs?
There are DNA drugs and RNA drugs •antisense oligonucleotide,ASO •small interfering RNA, siRNA •microRNA, miRNA •short hairpin RNA, shRNA •messenger RNA, mRNA •Plasmid DNA, pDNA •RNA aptamer •The guide RNA for the gene-editing tool CRISPR •A catalytically active RNA, ribozyme
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What are the Advantages and Disadvantages of Nucleic Acid Drugs?
Advantages: Short development cycle, fast target screening; A wide range of treatment areas; Resistant to drug resistance; Long-lasting effect; High success rate of R&D. Disadvantages: The drug itself has no targeting; Unstable in the body, easy to be removed.
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Advantages of PROTACS
1. For the undruggable targets:Transcription factors,Scaffolding proteins.2. Eliminate pathogenic proteins. 3. Ease of developing compounds with high potency/selectivity. 4. Could overcome drug resistance in cancer therapy
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What is a Cerebral Stroke?
"Cerebral stroke" is also called "stroke" or "cerebrovascular accident." Stroke is an acute cerebrovascular disease, a group of diseases caused by the sudden rupture of blood vessels in the brain or the blockage of blood vessels that prevents blood from flowing into the brain and causes brain tissue damage.
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When to Choose a Metastable Crystal Structure for Development?
The solubility and bioavailability of stable crystals are too low;A fast-release agent with a high dissolution rate is required.Polycrystalline forms will also have different mechanical properties, such as hardness, powder fluidity, compressibility, and bonding strength.
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Why Choose a Thermodynamically Stable Crystal Form for Development?
Without the influence of solvent and humidity, a polymorph which is thermodynamically stable at room temperature is the only stable form that is guaranteed not to convert to another polymorph.
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Why is the Study of Crystals Important in Meeting Registration Regulations?
Regulatory agencies require the thorough screening of drug polymorphisms and require pharmaceutical companies to make a validated choice of one of the forms or a prescribed mixture of forms. The U.S. FDA and the NMPA have set forth on this in the drug declaration, requiring research on drug polymorphism and providing corresponding data.
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