Registration Fees & Deadlines

Learning Objectives

At the conclusion of this workshop, participants should:

• Be familiar with various types of biologic products and their structural/functional characteristics
• Understand development phase-appropriate regulatory agency expectations associated with biologics characterization, development, production and testing
• Understand best practices in establishing a comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biologic and biosimilar products
• Understand Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biologic products
• Translate an effective biologics CMC strategy into effective regulatory submission content for biologic and biosimilar products

Who Should Attend?

This program will benefit early, mid-career, and senior subject matter experts (SMEs) and regulatory professionals in CMC working in development, registration and post-approval lifecycle management for biological products. There are no prerequisites for participation. It is recommended that Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges be taken prior to this course for early career SMEs.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

Day 1 (9:00 am – 4:00 pm EDT)

• Overview of types of biologic products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies)
• Regulation of Biologics in the US
• Establishing the TPP and QTPP and product teams
• Clinical-phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars. Each of the topics that follow will be discussed in depth from an early- and late-phase perspective of regulatory requirements. Early stage requirements will be emphasized in day 1 and later phase in day 2.
• Cell substrates & source materials, cell banks (storage, testing and other requirements)
• Upstream processing (preparation of media, fermentation, harvesting/recovery, critical process parameters, PAT)
• Downstream processing (purification strategies, process impurities, clearance studies)
• Final product formulation (stability issues, considerations in choosing storage temp)
• Characterization Testing
• Determination of cQAs
• Release and Stability Testing (Control Strategy)
• Setting Specifications
• Validation of analytical methods

Day 2 (9:00 am – 4:00 pm EDT)

• Comparability studies during the development stages
• Pre-IND meeting planning and strategy
• Clinical-phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued from day 1 for later stage products).
• Process development and validation
• Post approval changes – what is required?
• Adventitious agents risk management
• Sterility Assurance/Aseptic Processing

The agenda may vary based on changing requirements.

Speakers

Pat Cash
Analytical/Regulatory Expert in Biotechnology, Independent Consultant

Joseph Quinn
Biopharmaceutical Regulatory Affairs Consultant & Educator

Erica Shane, Ph.D
Independent Biotechnology Consultant

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions