Micro-lesson · Module 1
Discovery, manufacture, and clinical use have different dates
Place a manufacturing advance in the correct stage of development.
Educational information for healthcare professionals and the general public. Not individual medical advice, diagnosis, treatment, or a recommendation to use a compound.
Learning objective: Place a manufacturing advance in the correct stage of development.
The concept
In 1963, Merrifield published a paper on solid-phase peptide synthesis. The method used a support to facilitate assembly and separation during the process. Its historical significance was expanding the practical possibilities of producing defined sequences. In 1979, Goeddel and colleagues published the bacterial expression of synthetic genes for human insulin. This work linked genetic information and the production of peptide components. It represents an experimental milestone in recombinant technology.
Check your understanding
A timeline lists the 1979 publication on recombinant insulin production. Can it label that date as approval of every recombinant insulin product?
Answer and explanation
No. An experimental publication establishes what that investigation achieved. Manufacturing development, characterization, clinical testing, and authorization are different events. The historical contribution remains valuable without assigning it a later regulatory outcome. Use the date attached to the actual source and name the milestone precisely.
Continue learning
Explore Module 1 in PEPTIDE Academy for the complete lesson and further case discussion.
References
Bibliographic sources shown for transparency. Citation verification pending; no citation is marked verified.
- Sanger F. The Chemistry of Insulin. Nobel Lecture, December 11, 1958. Nobel Foundation. Primary historical source; the date identifies the lecture, not every experiment it recounts. No DOI or PMID.
- Vincent du Vigneaud — Nobel Lecture, December 12, 1955. Descriptive reference; original title not transcribed. Nobel Foundation. No DOI or PMID.
- Merrifield RB. Solid Phase Peptide Synthesis. I. The Synthesis of a Tetrapeptide. J Am Chem Soc. 1963;85(14):2149–2154. Primary research. DOI 10.1021/ja00897a025.DOI 10.1021/ja00897a025
- Goeddel DV, Kleid DG, Bolivar F, et al. Expression in Escherichia coli of chemically synthesized genes for human insulin. Proc Natl Acad Sci U S A. 1979;76(1):106–110. DOI: 10.1073/pnas.76.1.106. PMID: 85300.DOI 10.1073/pnas.76.1.106 · PMID 85300
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