Regulation, Quality & Compliance in ADC Manufacturing - Masterclass

About:

The manufacturing of Antibody-Drug Conjugates (ADCs) is intrinsically complex and a strong chemistry, manufacturing and control (CMC) strategy is vital due to the complex nature of these therapeutics and history of failures at both early and late stages. This training encompasses a comprehensive understanding of the primary technical and regulatory (FDA and EMA) challenges; focusing on the specific requirements for ADCs, which combine the targeting capabilities of antibodies with the cell-killing or effector capabilities of payload drugs. The overall operational excellence and Quality approach is highlighted as well as the critical points for control to ensure the consistency, purity and stability of ADCs, given their high potency and specific targeting mechanisms. Training also covers good manufacturing practices (GMP) procedures - especially tech transfer, documentation and facility controls. The latter being crucial for minimizing cross-contamination risks. This training combines theoretical knowledge with workshopping for deeper understanding to prepare professionals for the unique challenges in ADC manufacturing

Trainer Profile:

Dr. Len Pattenden, Managing Director, CMC Biopharma Ltd

Len has over 30 years of experience in both industry and academia. Len has been a company founder, COO and GMP site head/license holder, overseeing biopharma development and manufacture as well as outsourced CDMO activities. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. Len’s regulatory and licensing experience covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large pharmaceutical companies. He is a member of a Regulatory working group, the ISPE and BIA

Who Should Attend?

This training is essential for professionals from leading pharma manufacturing companies, including:

Quality
Quality assurance
Quality Control
CMC Managers/ Heads
Compliance
Regulatory Affairs
QA/QC Managers
Analytical Scientists
Development Scientists
Manufacturing
Process Development
Upstream/Downstream
R&D Scientists
Operations
& VC/investors in Biologics

Methodology:

The participants will acquire knowledge through interactive sessions that are structured like lectures, allocating ample time for various activities, Q&A sessions, and discussions. Additionally, the training emphasises practical learning, incorporating case studies, breakout sessions, interactive polls, and examples from real-case scenarios.

‍Key Outcomes:

• An understanding of the mechanism of action and pharmacology important to success of ADCs
• An understanding of the key steps and technical challenges of GMP ADC manufacture that create market-approval delays
• An insight into Regulatory drivers and how this impacts assessment of filings
• Operational excellence and Quality by Design (QbD) principles applied to ADCs
• Change management and tech transfer for ADCs
• Critical points for control to establish good CMC-compliant regulatory practices for ADCs
  

Training Schedule (10th & 11th September, 2024)

‍14:00 - 18:15 PM UK time

Additional Features:

• Online participants zone – a single source for all training materials as well as pre and post training communications
• Access to the recorded sessions for 7 days

Agenda

DAY 1     |     10 SEPTEMBER, 2024 (UK Time)

14:00 -15:00 Lecture 1: Introduction to ADCs and Mechanism of Action

Title: Unveiling the Complexity: Introduction to ADCs and Their Mechanism of Action

• Foundational lecture delves into the intricate world of ADCs
• Exploring ADC unique mechanisms of action to leverage the  targeting precision of antibodies combined with the potent  cell-killing abilities of payload drugs  
• Understand the critical role of this mechanism in the success  of ADCs and the challenges associated with their complex  nature

15:00 -16:00  Lecture 2: GMP ADC Manufacturing: Key Steps and Technical Challenges

Title: Navigating Complexity: GMP Manufacturing of ADCs - Steps and Challenges

• Dive into the heart of ADC manufacturing, exploring the key  steps and technical challenges that often lead to  market-approval delays
• This lecture provides a comprehensive understanding of the  intricacies involved in producing high-quality ADCs  
• Emphasis is the critical need for a robust CMC strategy to  overcome challenges and ensure manufacturing success.

16:00-16:15  Coffee Break

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