Chemistry, manufacturing, and controls (CMC) ANSWER C-E a. What information is i

Question

Chemistry, manufacturing, and controls (CMC)

ANSWER C-E

a. What information is included in the Chemistry and Manufacturing Introduction of the Guidance for Industry “Content and Format of IND Applications…”? Why is this information important?

b. What are the five key components for Drug Substance and the six key components for Drug Product?

c. Provide 5-6 examples of analytical data (and the techniques used for analysis) you can use to propose acceptable limits of the clinical trials material? Remember that the product is a protein (specifically, a MAb). Example: analytical data = pH of the drug substance; technique = measurement with a pH meter

d. Briefly describe the requirements for the manufacture of the placebo that will be used for Phase I studies.

e. For the general method of preparation of the drug substance, what is suggested to be the usual, most effective way to present this information?

Explanation / Answer

IND or Investigational New Drug is a programme developed by The United States Food and Drug Administration.

C 1). Analytical data : hydrophobic interaction chromatography

Analytical technique: liquid chromatography

2) Characterize the mAb profiles systematically

By mAbprofiler

3) Measure quantitatively the binding of a mAb

By flow cytometry

4) Analyzing mAb

By human leukocyte differentiation antigens (HLDAs)

5) Measured the reactivity pattern ( of Mab)

By cytometric density histograms

d. Placebo should be highly flexible, up to date , highly specialised. In manufacturing the placebo, the batch formula of the batch should be used for the clinical trial, flow chart should be mentioned including components and process control factors, description of manufacturing process are required.

e. Pharmaceutical formulation is the method of preparation of the drug substance.

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