Abridged 2020 Aseptic Conference Program 

Track Sessions

Barrier Track

  • Alternate Technologies – UV Decontamination, Tub Decontamination with Pulsed Light, E-Beam, H202 or UV-C
  • Practical Approaches to Implementing Barriers – High Speed Syringe Filling, Modernization of a Legacy CDMO Parenteral Manufacturing Facility
  • Materials Transfer and Disposable Technologies – Sterile Connectors, Standardization of Extractables Testing for Single-Use, Single-Use Assemblies for Drug Product

Aseptic Track

  • Viral Vectors, CAR-T, and Production Approaches – Autologous Cell Therapy Scale Out Planning, Formulation-Filling a Viral Vector for CAR-T Cell Cancer Therapy, Gene Therapy Facility Start Up
  • Robotics – Robotic Filling Isolators, Robotized Environmental Monitoring, Robotics in Clean Rooms
  • Small Scale/Clinical Batch Production – Sterile 503B Outsourcing Facility, Innovative Facility/Process Design, Clinical Scale Flexible Filling Line using Single Use Systems

Containment Track

  • Case Studies Part 1 – Cytotoxic, Robotics, High Potent Products, GMP, and Occupational Safety
  • Case Studies Part 2 – Flexible Fill & Finish, Validation of a Modular System, and Sterile API Manufacturing
  • Science & Technology – Glove Management, Robust Short Decontamination Cycles

Plenary Sessions

Monday 2 March

  • Opening Plenary Session – FDA Representative Invited
  • Industry Panel – Automated Visual Inspections

Tuesday 3 March

  • Women in Pharma Breakfast Session
  • Plenary Session – David Doleski, Compliance Head for Biologics Quality Operations, Sanofi
  • Hot Topics Group Discussion Sessions and Report-Out
  • Interactive Regulatory Panel – FDA Representatives Invited

Presentations Confirmed from These Companies

Bausch Advanced Technologies

Bristol-Myers Squibb

Commissioning Agents





Fresenius Kabi

Gilead Sciences

Kite Pharma


Oncotec Pharma


Oxford Biomedica

Project Farma

Robert Bosch Packaging Technology



Shook Pharma


Steriline Srl

United Therapeutics

Vetter Pharma–Fertigung GmbH & Co.