Innovative Methods for Prolonging Protein Drug Half-Lives: Implications for Drug Development

Macromolecular proteins and peptides have proven to be highly effective in treating serious human diseases. Over the past few decades, advancements in biotechnology have led to the development of numerous authorized protein therapeutics and drug products, which are now widely used in clinical research. However, a major challenge for protein therapeutics remains their short half-lives, primarily caused by rapid degradation in serum and swift elimination during clinical use. This is due to factors such as enzymatic degradation, renal clearance, liver metabolism, and immunogenicity.

In response to this challenge, researchers have made significant progress in developing strategies to extend the half-lives of protein therapeutics and biopharmaceutical products. One such approach is the use of polymers for drug half-life extension. Polymer conjugation, particularly PEGylation, has emerged as an efficient and widely used technique. PEGylation enhances pharmacokinetic properties by providing highly hydrophilic and largely non-toxic characteristics, making it a valuable tool in drug development.

As protein engineering technology evolves, bioactive natural protein conjugation has gained recognition as a promising strategy for prolonging drug half-lives, offering reduced toxic side effects. Various bioactive natural protein conjugation technologies are currently being developed, including:

Albumin-based half-life extension: Albumin conjugation is already widely used in several protein drugs available on the market.
Fc-Fusion-based half-life extension: The Fc-Fusion technique is highly effective for modifying most therapeutic proteins.
Transferrin fusion-based half-life extension: Transferrin fusion is an innovative approach with potential for clinical application in extending drug half-lives.
Moreover, the lack of efficacy remains a primary cause of drug candidate attrition. Drug half-life assays are essential in drug development as they determine the half-life of drugs, serving as the first critical step in selecting suitable candidates for clinical trials. To address this need, many contract research organizations (CROs) are offering advanced assay services. Creative Biolabs, for example, has developed a comprehensive half-life assay platform, providing high-quality in vitro and in vivo detection services for drug half-life evaluation.

As a leading global CRO specializing in drug development, Creative Biolabs has accumulated extensive experience in half-life extension, earning a strong reputation among clients worldwide. The company’s scientists continue to refine its half-life extension technologies, ensuring the delivery of optimal services to accelerate the progress of drug development.

Mon. Jan 6, 10:19pm

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