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FAQs

FAQs
Differencese of Quality Research Between Phase Ⅰ and Ⅲ?
Phase 1 clinical No need for comprehensive and complete validation of analytical methods (need for specificity, sensitivity, etc.)
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Classification Based on the Structural Form of Bispecific Antibodies
1) IgG-like bispecific antibody: ​Igg-like BsAb has an Fc part and has Fc-mediated effect function, such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cell-mediated phagocytosis (ADCP).
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Types of Bispecific Antibodies
With the development of technology and platform, bispecific antibody-hydrolyzed forms have been developed into more than 100 molecular forms. The whole can be divided into:Symmetric formats,Asymmetric formats and Fragment formats.
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How to Optimize Oral Bioavailability in the Drug Discovery?
1) Understanding the structural boundaries associated with oral absorption 2) Identifying/determining the cause of poor oral bioavailability of a compound family
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Importance of Pilot Scale-up
Uncertainty, the pilot scale is generally a production activity where the process is greater than kilogram level for the first time, and there are various uncertain factors.Security risks are uncertain.
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What is Ideal Synthetic Route?
​Economic and reasonable •Simple synthesis route, few synthesis steps •FDA: The proposed starting material should react multiple steps apart from the final intermediate of the API •The raw materials are easy to obtain and stable. •Intermediates are easily separated and stable.
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Characteristics of an Excellent API Synthesis Process
Feasibility,Controllability,Rationality
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What is the Goal of Process Development?
The purpose of API manufacturing process development is to establish a commercial manufacturing process that can consistently produce the API of expected quality.
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To What Extent does PGI Study Need to be Done?
In the late stage of process optimization, the impurities in the typical sample are systematically analyzed and exceed the identification limit. if it is speculated and confirmed as PGI, a purification study is needed, and limit control is carried out according to ICH M7.
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What are the Main Factors that Affect the Speed of R&D?
Long lead time for salt structure screening and crystal structure screening. Analysis method development and optimization is not deep enough, repeated development and optimization. The ability to find a better API purification method in a short time during process optimization. Lag in impurity study, methodological validation cannot be carried out quickly ❖The impurity coverage of the safety assessment batch is not comprehensive
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