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

Claranor

CRB

Evonik

Exelead

Fresenius Kabi

Gilead Sciences

Kite Pharma

Merck

Oncotec Pharma

FDA

Oxford Biomedica

Project Farma

Robert Bosch Packaging Technology

Sanofi

Seqirus

Shook Pharma

SKAN

Steriline Srl

United Therapeutics

Vetter Pharma–Fertigung GmbH & Co.

Ziel