Chemical modifications of protein therapeutics are common across approved drugs. Numerous examples exist, including PEGylated protein therapeutics, which have polyethylene glycol (PEG) chains attached to the protein to increase the systemic half-life in the body. In addition, a number of antibody-drug conjugates (ADCs) currently on the market consist of an anti-cancer agent linked to an antibody for targeted delivery of the agent to a specific cancer cell type.

This asynchronous online course provides participants with an understanding of important modification methods applied to protein therapeutics. It offers a unique opportunity to learn about the modification reaction, downstream processes, and analytical methods for the design and GMP manufacture of chemically modified biopharmaceuticals.

This course has been updated (June 2025) to expand coverage of one of the fastest growing anti-cancer biologics, the ADC. The course now highlights the site-specific conjugation and linker chemistry behind the clinical successes of third generation ADCs.

Fee

$399

Participate and you will learn

The course begins with an overview of protein chemistry as it relates to chemical modification and a survey of chemically modified proteins currently on the market. It then delves into the background and application of chemical modifications, manufacturing methods, analytical/characterization methods, and process optimization. By the end of the course, participants will be able to do the following:

• Identify the benefits of modification;
• Describe chemical modification techniques relevant to protein therapeutics;
• Explain how conjugation steps are carried out and list the reaction parameters that must be controlled to ensure consistency and quality of the product;
• Discuss the purification steps following modification that are required to remove process- and product-related impurities resulting from the conjugation reaction;
• Identify basic analytical methods used to assess quality of the modified protein;
• Apply the knowledge gained to evaluate analytical results from PEGylation steps, choose parameters that optimize conjugation reaction performance, and evaluate results from a study to chromatographically separate desired PEGylated product from impurities;
• Describe the chemistry and impact of site selective modifications with a focus on recent successes for ADCs.

Who Should Participate

Anyone with some background knowledge of biochemistry and processing who is interested in specialized chemistry and process considerations for chemical modification of proteinaceous therapeutics, including the following:

• Process development scientists (including advanced process development technicians) working on development of processes for chemically modified therapeutics;
• Validation specialists who want to know more about critical process parameters for modification reaction steps;
• Graduate students and postdocs interested in learning more about chemical modification of proteins.

Course Format

This course is self-paced and delivered totally online. This on-demand format enables participants to access—for 90 days—a series of recorded lectures with interactive components that have been created for independent, self-paced learning. The course is always available except for brief maintenance periods, and because no scheduled meetings or other real-time events are included, you can access materials whenever it’s convenient. The course is presented through NC State’s learning management system, Moodle; upon registration, participants are provided with instructions for accessing the course website.

Modules

Materials are divided into five modules, which are listed below.

1. Background and application of chemical modifications
2. Manufacturing methods
3. Analytical/characterization methods
4. Process optimization 
5. Chemistry of Site-selectivity

Instructors

• Gary Gilleskie, Ph.D.
• Kurt Selle, Ph.D.
• Sara Siegel, Ph.D.
• Miles Calzini, Ph.D.

Register and You Will Receive

• Access to approximately nine hours of instruction
• Course certificate upon completing all course assessments