Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges

When:  Apr 17, 2019 from 9:00 AM to 4:00 PM

This workshop provides an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other highly regulated regions. The class is designed to orient professionals, managers and scientists responsible for biopharmaceutical CMC development and preparation of dossiers to technical issues that must be addressed in biologic product development and registration. Topics will include biological product characteristics; CMC regulations and guidance applicable to biologics; Quality by Design, adventitious agents risk management; source material, cell & seed banks; upstream and downstream processing, formulation and final product production; characterization and testing; demonstrating comparability.  

Program Dates:  17-18 April 2019
Registration Closes:  10 April 2019 
Refund Deadline: 18 March 2019 

RAC Credits: 12 (Upon attending and completing the program)
Will the meeting be recorded?  No

Registration to 18 March 2019
RAPS Members:  $1050
Nonmembers:  $1150

Registration from 18 March to 10 April 2019
RAPS Members:  $1150
Nonmembers:  $1250

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.

Program Schedule

Wednesday, 17 April (9:00 am – 4:30 pm)

  • Types of biologic products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies)
  • Biologics/Biosimilars product characteristics and corresponding regulatory implications
  • Biologics/Biosimilars CMC regulation and guidance framework
  • Clinical phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars
    • Cell substrates & source materials, cell banks
    • Upstream processing

Thursday, 18 April (9:00 am - 3:00 pm)

  • Clinical phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued)
    • Downstream processing
    • Final product formulation
    • Characterization
    • Testing & specifications
  • Adventitious agents risk management
  • Validation
  • Demonstrating comparability & comparability protocols

NOTE: The agenda may vary based on changing requirements.

Location
The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850

Faculty

Patricia Cash, PhD, Independent Biotechnology Consultant, LLC  
Joseph Quinn, Biologics Regulatory Consultant

Program 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 and biosimilars 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 regulatory professionals in CMC working in development, registration and post approval lifecyle management for biologic/biosimilar products. There are no prerequisites for participation.

Cancellation

All requests for cancellation must be received in writing or by calling customer service by 18 March 2019. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS.

Proof of Attendance
RAPS will send an electronic letter or a certificate of attendance upon request.

Questions
Call RAPS Solutions Center at +1 301.770.2920, Ext 200

Other Information
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.

Registration Form 

If it is your preference, please use the Registration Form to register by mail, email or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer. When mailing your payment, please ensure that you attach a completed registration form.

Program Contact
Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, Ext 291

Area Hotels

Hilton Garden Inn Rockville
14975 Shady Grove Road
Rockville, MD 20850
(240) 507-1800

Courtyard by Marriott Rockville
2500 Research Boulevard
Rockville, MD 20850
(301) 670-6700

Radisson Hotel Washington DC - Rockville
3 Research Center 
Rockville, MD 20850
(301) 840-0200


Location

9630 Gudelsky Dr Bldg II
Rockville, MD 20850-3481