More and more therapeutic proteins are coming to market, including biosimilars. With the support of our advanced protein engineering platform established for many years, Creative BioMart has successfully designed a variety of therapeutic proteins with novel topologies and functional activities based on computational design. However, due to the complexity of therapeutic proteins and the presence of contaminants such as host cell proteins and nucleic acids) require extensive analysis of their exact chemical composition. Our scientists provide you with a comprehensive customized therapeutic protein species assessment service to analyze and characterize therapeutic protein species, ensuring their safety and reliability.

Therapeutic proteins have become the leading drugs in the vaccine and diagnostic biological classes of the drug market. Compared to traditional small-molecule drugs, these therapeutic proteins are produced by a very wide range of expression system platforms, such as E. coli, yeast, mammals, insects, etc. Various process-related impurities such as host cell proteins and contamination with different kinds of therapeutic target proteins are generated during this process. In addition, the structures of therapeutic proteins range from relatively disordered to highly ordered multimeric states. Their activity and side effects are highly influenced by their exact chemical composition. Small changes in the exact composition can lead to the appearance of unwanted protein species, which can lead to dangerous outcomes such as reduced or complete loss of activity of the active pharmaceutical ingredient leading to changes in the intended efficacy or potential toxicity to the patient. Contaminants can be co-purified with therapeutic target proteins and variant protein species are mostly present at lower concentrations, thus requiring very robust, sensitive and selective identification as well as efficient and economical purification techniques.

Fig 1. Schematic illustration of some of the many applications of LC-MS for the biophysical characterization of antibody-based therapeutics. (Robotham A C, et al., 2020 )

Services

To reduce the generation of contaminants and variant protein species during therapeutic protein development, candidate proteins need to be carefully evaluated for their developability early in the process, including manufacturability, biophysical properties, stability, and in vivo adaptation. Creative BioMart has successfully established a therapeutic protein analysis and characterization assessment platform to accurately analyze its contaminants (host cell proteins and DNA) and chemical composition. Our scientists have employed a variety of easier, more reliable, faster, and automatable tools for in-depth evaluation of therapeutic proteins. For example:

(1) Enzyme-linked immunosorbent assay (ELISA).

(2) Western blot.

(3) Liquid chromatography (LC).

(4) Mass spectrometry (MS).

(5) Sodium dodecyl sulfate capillary electrophoresis analysis.

(6) Microfluidic capillary electrophoresis-electrospray ionization (ESI) method.

(7) Chromatographic staining method.

(8) Affinity-based methods (e.g. lectin blotting).

(9) Immunoaffinity technology.

Given that the development of biologics in new protein forms has entered a new era, the methods and aspects of the production of therapeutic proteins for preclinical research need to be strictly controlled. We are committed to providing a one-stop service for the development process of therapeutic proteins, not only for the expression and purification of therapeutic proteins, but also for analytical characterization. We offer tailor-made services for your project:

• Screening service: allowing for a highly targeted and project-specific set of molecular parameters or responsibilities to be assessed early in a project to overcome or eliminate key developability issues and screen candidate proteins. Analysis factors include: expression vector and host, titer and molecular integrity, process conditions, etc.
• Profiling service: distinguish candidates based on initial production method (expression and purification) and preliminary quality attribute assessment for relative ranking of candidates.
• Lead development service: Utilizing advanced analytical characterization methods to provide comprehensive developability and risk/effort assessments of final candidates as well as final cell lines, initial scalable purification processes, and preformulation data.

Service Principle

Creative BioMart is based on innovative, pragmatic and honest, adhering to the tenet of "Quality is our life, providing customers with the best quality service", providing customized services to customers around the world.

We will be glad to discuss details of intended interaction studies with you and develop experimental strategies/methods tailored to your requirement. Our customer service representatives are enthusiastic and trustworthy 24 hours a day, Monday to Friday. If you are interested in our services, please do not hesitate to contact us for more information or to discuss in detail.

Reference

1. Fuh M M, Steffen P, Schluter H. (2016) Tools for the analysis and characterization of therapeutic protein species[J]. Biosmilars. 6: 17-24.
2. Robotham A C, Kelly J F. (2020) LC-MS characterization of antibody-based therapeutics: recent highlights and future prospects[M. Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics. Elsevier, 1-33.

• B Cell Epitope Prediction Service
• Ion Channel Modeling Service
• Molecular Dynamics Simulation of RNA Systems
• T Cell Epitope Prediction Service
• Therapeutic Protein Folding Recognition Service
• Therapeutic Protein Functional Motion Analysis Service