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Updated: Jul 9, 2026
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A Convenient and General Expression Platform for the Production of Secreted Proteins from Human Cells
Published on: July 31, 2012
Recombinant therapeutic proteins: production platforms and challenges
1Institute for Pharmaceutical Biology, Goethe University, Frankfurt/Main, Germany. Dingermann@em.uni-frankfurt.de
Biotechnology Journal
|November 28, 2007
Summary
Recombinant therapeutic proteins offer valuable treatment options, with minor modifications enhancing drug delivery and efficacy. Despite some immune response, these advanced protein drugs demonstrate good tolerability and clinical effectiveness.
Area of Science:
- Biotechnology and Pharmaceutical Sciences
- Molecular Biology and Drug Development
Background:
- Over 120 recombinant drug substances, including insulin since 1982, are now valuable therapeutics.
- Diverging from original human forms addresses pharmacokinetic challenges in recombinant drugs.
- Manufacturing and packaging changes can influence the safety of therapeutic proteins.
Purpose of the Study:
- To evaluate the therapeutic potential and safety of modified recombinant proteins.
- To explore the impact of cellular entry and intracellular targeting by recombinant drugs.
- To reassess the clinical significance of immune responses to recombinant protein variants.
Main Methods:
- Review of approved recombinant drug substances and their therapeutic applications.
- Analysis of pharmacokinetic challenges and solutions through structural modifications.
- Assessment of clinical data regarding safety, immunogenicity, and efficacy.
Main Results:
- Recombinant proteins capable of cellular entry enable novel intracellular targeting strategies.
- Immune responses to protein variants are generally well-tolerated, contrary to initial concerns.
- Dosing adjustments based on antibody titers can manage neutralizing antibody activity.
Conclusions:
- Modified recombinant proteins offer significant therapeutic advantages beyond exact human replication.
- Cellular-penetrating recombinant proteins open new avenues for treating intracellular targets.
- Clinical demonstration of efficacy and safety, proving superiority, remains essential for therapeutic proteins.
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