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The 2021 PDA Aseptic Processing of Biopharmaceuticals Virtual Conference will address topics related to the manufacturing of sterile drug products and patient-friendly application systems in addition to providing updates on the COVID 19 impact in the pharmaceutical manufacturing environment presented by industry leaders and regulatory inspectors. This conference will update you on the latest new technologies in fill-finish operations (robotics) considering current and upcoming GMP regulations. It will also provide updates into market and technology trends for more patient-friendly injection systems.


Presentation topics will be divided into two parts:


Manufacturing:

  • Aseptic Manufacturing in times of Covid-19
  • Manufacturing capacities
  • Primary packaging sourcing
  • Operations management
  • A CMO perspective
  • Filling Lines & Filling Systems
  • Best practices for Extractables testing of Single-Use components
  • Important considerations for Aseptic techniques

Container Closure Components and Devices:

  • Container Integrity Testing
  • Visual Inspection; auto vs. manual
  • Container Closure Components: Glass, Elastomers, etc.
  • Market Trends in Patient-Friendly Injection Systems
  • Devices: Pens, Autoinjectors, and Wearables


Stay tune for more event details, including an exciting line up of speakers and sessions.


Register and save now for the early bird rate!

Speakers

Luigi Annoni

Senior Aseptic Specialist at IMA Life

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Enrico Barichello

Product Manager at Stevanato Group

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Jia Min Boo

Technical Account Specialist at West Pharmaceutical Services

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Javier Camposano

Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.

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Richard Chai

Technical Service Manager at Steris

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Derek Duncan

Director of LIGHTHOUSE Instruments

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Michael Edey

Principal Engineer, Component Control & Optimization at Pfizer

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Max Fernandez

Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.

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Agenda

Welcome Remarks
Opening Address
SESSION 1: Aseptic Manufacturing Process in times of COVID-19, Supply Chain, Primary Packaging Materials
Keynote Speech: From Efficacy to Implementation: Regulatory Strategy and COVID-19 Vaccine Development
From Monoclonal Antibodies to Vaccines: Overcoming Barriers and Providing a Rapid Response to Meet Pandemic Requirements
SESSION 3: COVID-19 and Novel Technologies
Keynote Speech: The COVID-19 Pandemic – Where Did It Come From and Where Is It Going?
Clinical Production of Human Injectable siRNA Nanoparticle Therapeutics
Make it Right: Best Practices for mRNA Manufacturing
Panel Discussion and Q&A
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