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Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

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Building better drugs: developing and regulating engineered therapeutic proteins.

Chava Kimchi-Sarfaty¹, Tal Schiller, Nobuko Hamasaki-Katagiri

¹Laboratory of Hemostasis, Division of Hematology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA.

Trends in Pharmacological Sciences

|September 25, 2013

Summary

Engineered therapeutic proteins offer significant advantages over native proteins but require careful safety and efficacy assessments. Advancements in basic science aim to create predictable, risk-based criteria for developing these complex, vital medicines.

Keywords:

drug development drug safety immunogenicity quality by design risk mitigation

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Area of Science:

Biotechnology
Pharmaceutical Sciences
Protein Engineering

Background:

Native proteins often lack optimal drug characteristics, necessitating protein engineering.
Second- and third-generation therapeutic proteins are increasingly developed to enhance product attributes and process efficiency.
Rapid advancements in platform technologies facilitate the engineering of therapeutic proteins.

Purpose of the Study:

To review key technological innovations in engineered therapeutic proteins.
To discuss advancements in underlying basic science for risk assessment.
To highlight the development of science-based criteria for predicting and managing risks associated with engineered proteins.

Main Methods:

Review of technological innovations in protein engineering for therapeutics.
Analysis of advancements in fundamental biological sciences relevant to protein therapeutics.
Discussion on developing risk assessment and management strategies.

Main Results:

Engineered therapeutic proteins present considerable advantages but can impact drug safety and efficacy.
Technological innovations have significantly improved the development of engineered proteins.
Basic science advancements enable science-based risk prediction and management.

Conclusions:

Engineered therapeutic proteins are crucial in modern medicine, despite development challenges.
Developing science-based criteria for risk assessment is essential for predictable licensure.
Integrating technological and basic science advancements promises safer and more effective protein-based therapies.