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Introduction to Chemical Modification of Protein Therapeutics

online course

Sept. 7–10, 2021

Why should you attend?

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, there are a number of antibody-drug conjugates (ADCs) on the market that consist of an anti-cancer agent linked to an antibody for targeted delivery of the agent to a specific tumor.

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

Attend 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, and
  • Identify basic analytical methods used to assess quality of the modified protein

Participants will apply the knowledge gained from the self-paced online materials in a live lab-based workshop that concludes the course. This live session, which is facilitated by the course instructors, focuses on the reaction and purification steps to produce a model PEGylated protein.

Who should attend

Anyone with some background knowledge of biochemistry and processing 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 and schedule

This four-day online course, which begins Tuesday, Sept. 7 and ends Friday, Sept. 10, 2021, is delivered via a blended live and on-demand format. This format mixes instructor-led training in two live sessions with approximately five to six hours of online content designed for independent, self-paced learning.

On-demand materials

Once the course begins, participants can complete the on-demand materials at any time before the second live session, which concludes the course. NC State's learning management system, Moodle, hosts the on-demand portion of the course, which consists of recorded lecture material with interactive elements and related resources (e.g., discussion forums). Four modules make up the on-demand materials:

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

Upon registration, participants will be provided with instructions for accessing the course website. The Moodle course site will remain available to participants for 30 days after the course ends.

Live sessions

This course features two live discussion sessions/workshops. These will be led by the instructors via Zoom on the following dates:

  • Tuesday, Sept. 7, 1:00–2:00 p.m. EDT – This session provides an introduction to the course, its instructors, and the website hosting the self-paced lecture materials. The session also defines and establishes the importance and benefits of chemically modified protein therapeutics.

  • Friday, Sept. 10, 8:30 a.m.–12:30 p.m. EDT – This session focuses on process optimization and provides participants with the opportunity to apply their knowledge of chemical modifications, protein chemistry, modification benefits and techniques, and manufacturing and analytical/characterization methods. Participants will work through and discuss an example of chemical reaction parameters for a specific modification and its purification, characterization, and troubleshooting. Ample time will be provided for questions.
    • Note! Because this live session emphasizes active participation and discussion, participants are expected to complete the on-demand modules in advance.

Important: To ensure the privacy of participants, live sessions will NOT be recorded. Therefore, participants unable to attend at the dates and times specified will miss those sessions.

Instructors

Register and you will receive

  • All information necessary to participate in course activities
  • Approximately 10–12 hours of instruction
  • Certificate of attendance

Register


Fee

$1,375

Payment

Payment by credit card must be made at the time of registration. Prior to registration, please direct any questions to melody_woodyard@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 email Erica Vilsaint at embrown4@ncsu.edu.

If a course is full: Waitlist policy

If a course you want to take is already full, you are welcome to email melody_woodyard@ncsu.edu and ask to be placed on a waitlist for that course. The waitlist is used to fill any seats that become available when individuals registered for the course are unable to attend. If one or more seats become available, individuals on the waitlist are contacted in the order in which they were added to the list.

In addition to ensuring popular courses remain full, waitlists provide a means of tracking interest and determining if additional sessions are necessary. BTEC makes every effort to schedule additional course offerings if sufficient people are wait-listed. If a new offering is scheduled, those on the waitlist are notified before registration opens to the public.

Placement on a waitlist does not commit individuals to attending a course. It simply ensures that they are given first opportunity to enroll if a seat becomes available in a full course and that they are among the first to know if an additional course offering is scheduled during the current year.

BTEC is unable to provide information about the number of those wait-listed for any given course or an individual’s place on such a list.

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 melody_woodyard@ncsu.edu or fax to 919-513-1697.

CANCELLATION BY BTEC

BTEC retains the right to cancel a professional development short course no less than 10 business days in advance of the scheduled course start date. Registrants will be notified by BTEC if a course is canceled and will receive a full refund of registration fees paid. BTEC is not responsible for participants' costs incurred due to cancellation.