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NIBRT Symposium in Association with West Pharmaceutical Services:

Understanding Risks Associated with Containment and Delivery Systems

The purpose of this symposium is to bring about awareness of the important characteristics of materials, processes and components of the system, which protect and deliver biologic products and ensure manufacturability. This event will provide an opportunity to hear from Irish regulators, understand the role of containment and delivery systems, as well as hear unmet needs from end users.

  • February 23, 2017
  • 8:00 a.m.
  • Dublin, Ireland
Agenda

For the complete event agenda please click the link above. 

Address:
National Institute for Bioprocessing Research and Training
Fosters Avenue
Mount Merrion, Blackrock, Co.
Dublin, Ireland

Phone: +353 (0) 1 215 8100

Email:info@nibrt.ie

Understanding Risks Associated with Containment and Delivery Systems Across the Biologic Product Lifecycle from Formulation to Commercialization

The purpose of this symposium is to bring about awareness of the important characteristics of materials, processes and components of the system, which protect and deliver biologic products and ensure manufacturability. This event will provide opportunity to hear from Irish regulators, understand the role of containment and delivery systems, as well as hear unmet needs from end users. A discussion forum on how alliances can be built to facilitate speed to market, enabling comprehensive product and process understanding will be a key outcome of the event. 

Learning Objectives:
There are multiple challenges to be considered when qualifying containment and delivery systems for intended use. This symposium will provide insight on:

  • Visible and sub-visible particulate contributions from containment systems
  • Risks for biologic de-stabilization or degradation when in contact with various materials
  • Assessment of extractables and potential for leachables
  • Assurance of sterility through integral containment systems
  • Compatibility of materials for intended use and cold storage

Efficiency to market can be achieved when delivery systems are considered in early stages of development. Concepts on developing delivery systems and lifecycle management will be addressed as they relate to:

  • Understanding delivery system performance and functional requirements
  • Options for fill-fill finish operations and tech transfer verification
  • Concerns for shipping and handling

Building upon information from development to commercialization

Audience:
Biologic Innovators/Formulators, Academics, Directors of Manufacturing Operations/Technology, Research/Analytical Scientists, Quality Assurance, Regulatory Affairs, Packaging/Device Engineers, Clinicians, Human Factor Engineers, Marketing Leads

Thursday, February 23

Registration and Networking Breakfast

8:00 - 9:00

Regulatory Trends and Emerging Issues for Developing and Manufacturing Biologics

9:00 - 9:30

Diane Paskiet, Director of Global Scientific Affairs, West Pharmaceutical Services

Awareness of the regulatory environment is an important aspect when planning to commercialize biologic product. Expectations from regulators will depend on the legislation in each country but a common trend is towards implementing risk based approaches in development and manufacture of biologic products. This section will provide a basic background on risk management and highlight similarities/differences between United States and Europe.

  • Regulatory Challenges and Need for Scientific Evidence
  • GMPs and Lifecycle management

Understanding Materials and Components of Delivery Systems

9:30 - 10:15

Fran DeGrazio, VP, Scientific Affairs & Tech Services, Research & Development

The advent of biologic drug products in the pipeline of many organizations is driving different challenges in packaging and delivery of parenteral products. Biologic drugs are more sensitive to their environment and materials they come in contact with. This presentation will take a review of technical trends and risks relating to biologic drug packaging including considerations relating to combining the filled drug package with its delivery system to assure patient safety and appropriate qualification for its final application. Specific topics will include:

  • Considerations for Selecting Components and Delivery Systems
  • Identifying Risk Factors Impacting Biologic Quality
  • Case examples including: Container Closure Integrity, Leachables /Extractables, Material Compatibility, Particles, Protein Aggregation
  • How to acquire knowledge to make informed decisions

Q&A

10:15 - 10:30

Networking Break

10:30 - 11:00

Development Strategies for Sterile Injectable Drugs

11:00 - 12:15

Luca Andretta, Senior Director, Sterile Operations, Patheon
Annalisa Barile, Patheon

  • Do you know what the regulators are looking for in a sterile injectables production facility?
  • The complexities of developing a new sterile injectable drug – understanding the target product profiles, formulation development and manufacturing strategies.
  • Challenges and latest solution for storage, handling and shipping of biologics 

Q&A

12:15 - 12:30

Networking Break and Lunch

12:30 - 13:45

Patient Centric Solutions: Self-Injection Devices

13:45 - 14:15

Nicolas Brandes, Director, Market Development EU/Asia, Innovation & Technology

Keeping up with new drugs in development and the technologies to support them requires a novel approach to drug delivery. With a steady pipeline of biologics and biosimilars poised to come onto the market, pharmaceutical companies need innovative device solutions that can keep up with the drug delivery requirements demanded by advanced biologics. From manufacturing to delivery, self-injection devices should be designed with patient safety and ease of use in mind, but must also suit the sensitivity of the drug product itself. The following will be covered:

  • Trends in Today’s Drug Delivery
  • Improving the Patient Experience Through Design
  • Understanding delivery system performance and functional requirements
  • Selection Criteria for Choosing the Right Self-Injection System
  • How can the right device selection help you?

Break-out Discussions: Ask the Experts

14:15 - 15:00

Networking Break

15:00 - 15:30

Panel Discussion and Closing Remarks

15:30 - 16:00