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Introduction to Chemical Modification of Protein Therapeutics Release 1.5

online course

Delivery methods

Course content

downstream course
Downstream

This course can count toward your Professional Certificate in Biomanufacturing Science.

Why should you take this course?

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.

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.

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. Note that although lecture recordings are not downloadable, PDF versions of slides are available to participants.

Modules

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

  1. Background and application of chemical modifications
  2. Manufacturing methods
  3. Analytical/characterization methods
  4. Process optimization

Instructors

Register and you will receive

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

Register

Fee

$399

Payment

Payment by credit card must be made at the time of registration. Prior to registration, please direct any questions to mswoodya@ncsu.edu.

Pre-course communication

Upon successful registration for a course, you will receive an automatically generated email with information about how to access the online materials. If you do not receive this email within one business day of registering, please contact Serena Hodge, Industry Training Coordinator, at shodge@ncsu.edu.

Extensions

After registering, you will have 90 days to complete the course, which is always available (except for brief maintenance periods). Requests for extensions beyond the 90 days must be requested within 30 days of course access end date and will be considered on a case-by-case basis. Extensions are limited to one additional 30-day access window.

Short course cancellations

CANCELLATION BY REGISTRANT

Enrollment may be canceled within 10 business days (minimum two weeks) of the registration, subject to the conditions noted below. A 50% cancellation fee is charged for each registration canceled. Refund of the remainder of the registration price is subject to the following conditions:

  • The course material must not have been accessed by the registrant.
  • The registrant must request the cancellation within 10 business days of the registration.

To cancel a registration and be eligible for a refund of course fees, you must notify BTEC by e-mail to mswoodya@ncsu.edu.

CANCELLATION BY BTEC

Cancellation by BTEC does not apply to this course.