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Antibody–Drug Conjugates (ADCs): CMC Development and Regulatory Strategies

15 July 2026 | 1-Day Live Online Course

Original price was: £595.Current price is: £476.

Gain the knowledge and strategies to navigate CMC challenges and regulatory requirements for successful ADC development.

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Enrol before 12 June to save 20% (July Course)

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Antibody–Drug Conjugates (ADCs) represent a rapidly growing therapeutic class that combines the targeting capabilities of monoclonal antibodies with the potency of cytotoxic drugs. Their complex structure presents unique CMC (Chemistry, Manufacturing & Controls) challenges, spanning antibody production, linker chemistry, conjugation, and formulation.

 

This course provides a comprehensive overview of CMC considerations for ADC development, including manufacturing challenges, regulatory expectations in the EU and US, and strategies for clinical and commercial development. Participants will gain insights into regulatory guidelines, comparability, and quality requirements that underpin successful ADC submissions.

Key Learning Objectives

 

  • Understand the structural complexity of ADCs and their implications for CMC.
  • Identify key challenges in manufacturing and analytical characterisation.
  • Interpret regulatory expectations for ADC CMC submissions (FDA, EMA, ICH).
  • Apply risk-based strategies for control of critical quality attributes (CQAs).
  • Anticipate challenges in scale-up, comparability, and lifecycle management.
  • Integrate CMC considerations into ADC development strategies.

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

15 July 2026

1-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (trainer, venue, who should attend?)

Course Information

Course Information

  • The course begins at the time stated below
  • The course is broken up into sessions outlined below
  • There will be breaks between sessions

15 July 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

180 mins | 9:30 AM UK

Introduction to ADCs and Their CMC Challenges

  • Overview of ADC structure: antibody, linker, and payload
  • Comparison with monoclonal antibodies and small molecules
  • Unique CMC challenges of ADCs

 

Manufacturing Considerations

  • Antibody production and characterisation
  • Linker and payload: synthesis, stability, and safety considerations
  • Conjugation strategies and process development
  • Formulation development and drug product challenges

 

Analytical and Quality Considerations

  • Defining and controlling Critical Quality Attributes (CQAs)
  • Analytical methods for ADCs (potency, DAR, heterogeneity)
  • Impurities, stability, and comparability
Session 2

180 mins | 1:30 PM UK

Regulatory Landscape for ADCs

  • FDA and EMA expectations for ADCs
  • Relevant ICH guidelines (Q5, Q6, Q8–Q12, Q14/Q2(R2))
  • Quality and safety considerations in regulatory submissions
  • Common regulatory questions and challenges

 

CMC Development Strategies

  • Linking CMC to clinical development stages
  • Scale-up and tech transfer considerations
  • Control strategies and risk management approaches
  • Lifecycle management and post-approval changes

 

Case Studies and Best Practices

  • Examples of ADC development and regulatory approval pathways
  • Lessons learned from past submissions and regulatory feedback

 

Wrap-Up and Q&A

  • Key take-home messages
  • Open Q&A discussion
Andrew Willis - Educo Trainer

Andrew Willis is a regulatory and development consultant with 35 years of experience. His management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

 

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

 

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.

 

He currently delivers extensive training courses in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.

This course is suitable for professionals in:

  • CMC Development and Manufacturing
  • Regulatory Affairs and Quality Assurance
  • Analytical Development and Characterisation
  • Process Development and Tech Transfer
  • Project Management for Biologics and ADCs

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Antibody–Drug Conjugates (ADCs): CMC Development and Regulatory Strategies

15 July 2026 | 1-Day Live Online Course

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