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In Silico Degradation/PTMs Evaluation and Improvement

A variety of post-transcriptional modifications (PTMs) and degradations shows subtle or significant effects on the structures, bioactivities, stabilities, immunogenicity of pharmaceutical proteins. Based on vast experience and solid technical strength, Creative Biolabs offers comprehensive in silico degradation/PTMs evaluation and improvement services to facilitate the commercialization of your therapeutic proteins.

Necessity of Degradation/PTMS Evaluation

Recombinant therapeutic proteins, especially monoclonal antibodies and Fc-fusion proteins, have achieved dramatic development and been one of the most efficient and fastest-growing pharmaceuticals in recent years. However, the increasing market demands bring new challenges for biologics manufacturers and developers in quality and safety assurance, the majority of which is resulted from degradation or PTMs of proteins.

Degradation and PTMs occur once proteins are synthesized or being translated from an mRNA molecule. Protein degradation (also known as proteolysis) is a series of peptide bonds hydrolysis processes by the influences of pH, enzymes, even PTMs. Degradation is part of protein conversion and therapeutic protein metabolism in living organisms. PTMs are a sundry set of chemical, biological, and functional modifications of proteins following protein biosynthesis, commonly including deamidation, oxidation, glycosylation, unpaired cysteine, C-terminal lysine cleavage, N-terminal cyclization, etc., which plays a fundamental role in structures, heterogeneities, half-life, immunogenicity, and biological activities of proteins.

In light of the universality and importance of degradation and PTMs, any a fine variation or change in degradation/PTMs may exert a great impact on the structures, functions, and activities of the therapeutic proteins. Thus, degradation/PTMs evaluation and improvement both in silico and experimental methods are required to assess and optimize the manufacturability of the multitudinous therapeutic protein candidates.

Services

Degradation/PTMs of recombinant proteins have important effects on their chemical stabilities, pharmacokinetic characteristics, therapeutic effects, and safety, which increase the risk of changes in protein product properties in further processes. To minimize resource waste and avoid potential clinical failure, Creative Biolabs has developed a set of in silico degradation/PTMs evaluation and improvement tools for computational manufacturability assessment of target therapeutic candidate proteins. Various potential degradation/PTMs, such as glycosylation, glycation, free cysteine residues, chemical degradation sites, etc., can be analyzed and conjectured based on primary structures of proteins and modeling by professional in silico module of our CreDA™ platform. In addition, we also provide customized improvement solutions for degradation/PTMs to optimize the feasibility and manufacturability of the target candidate.

Features of Our Services

As a trusted research partner in the field of biotherapeutics, Creative Biolabs must be a well-recognized partner of choice for your in silico manufacturability assessment and optimization projects by supplying either individual service modules or fully comprehensive service. If you have any questions, please contact us to discuss your requirements.


All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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