RAPS Workshop: Biologics CMC: Phase Appropriate Development

With an emphasis on the product development challenges and regulatory expectations in the US, Europe and other highly regulated regions, this workshop provides an in-depth study of the chemistry, manufacturing and control (CMC) product development requirements and best practices associated with biopharmaceuticals.

Specifically designed for RA/QA professionals, managers, development scientists and others responsible for biopharmaceutical CMC development and preparation of dossiers, this in-depth discussion will take a regulatory approach to the technical issues that arise during biopharmaceutical product development and registration.

Topics will include:

Biological Product Development From Early Phase to Commercialization
Source Material
Cell & Seed Banks
Upstream and Downstream Processing, Formulation and Final Product Production
Characterization and Testing
Setting Specifications at Early and Late Stages
Demonstrating Comparability
CMC Regulations and Guidance Applicable to Biologic products
Adventitious Agents Risk Management

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 the lifecycle aspects of process development, manufacturing, product characterization, specification setting 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 scientists, subject matter experts (SMEs) regulatory and quality professionals in CMC working in development, registration lifecycle management for biological products. There are no prerequisites for participation. It is recommended that the Workshop: Biologics CMC: Regulatory Challenges and Trends be taken prior to this course for early career SMEs.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

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
Establishing the TPP and QTPP and cross-functional 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)
- 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
Adventitious agent risk management
Sterility Assurance/Aseptic Processing

***The agenda may vary based on changing requirements.

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 [email protected]. 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 [email protected] with the event title, name of the original registrant and the contact information for the new attendee.