UPSTREAM PROCESS INTENSIFICATION: REAL-WORLD RESULTS

• Upstream Process Intensification: Real-World Results

  Sonnet BioTherapeutics Chief Technology Officer Susan Dexter, single-use and process intensification pioneer Parrish Galliher, and Bioprocess Online Chief Editor Matt Pillar joined at the last Bioprocess Online Live for an in-depth discussion on upstream process intensification in practice.

• Why Invest In Process Intensification?
• Supplier Qualification & Cost Of Perfusion Intensification
• Process Intensification: ROI Realities & Implementation Considerations
• Regulatory Considerations For Process Intensification

GENE & RNA THERAPIES: REGULATORY REQUIREMENTS TAKE SHAPE

• Gene & RNA Therapies: Regulatory Requirements Take Shape

  Unprecedented progress in advanced therapy medicinal product development platforms leveraging AAV, mRNA, and oligonucleotide technologies are testing the mettle of biopharmas and regulatory bodies alike. Check out our On-Demand presentation of BioProcess Online Live - Gene & RNA Therapies: Regulatory Requirements Take Shape. Learn how to form up your own regulatory strategy, align your data with the most current FDA guidance, and develop a mutually-beneficial relationship with regulators in this interactive discussion with executives on the front lines of emerging ATMP regulatory requirements.

• Forming Up A Regulatory Strategy: When And How To Start
• Regulating Personalized Therapeutics: Are There Precedents?
• Accommodating The FDA: Handling Change Management In Your Regulatory Strategy
• FDA Regulations: What's Guidance, What Are Requirements, & What Matters Most?

VACCINE MANUFACTURING & REGULATORY ADVANCES: RIDING COVID'S COATTAILS

• Vaccine Manufacturing & Regulatory Advances: Riding COVID's Coattails

  Accelerated by the COVID-19 pandemic, nucleic acid, viral vector-based, inactivated, and other vaccine tech targeting a host of disease states are experiencing a rapid resurgence among biopharmas large and small. Learn how next-generation vaccine manufacturers are changing the egg yolk manufacturing paradigm and seizing an unprecedented regulatory momentum.

• Today's Biggest Vaccine Manufacturing Challenges
• Vaccine Platforms & Platform Variables
• Will Biopharma Regulators Maintain Their Accelerated Pace?
• Post-COVID Biopharma Regulatory Reactions

TACKLING THE CELL & GENE MANUFACTURING TALENT CRUNCH

• Tackling The Cell & Gene Manufacturing Talent Crunch

  Join Project Farma and Precision ADVANCE leaders Anshul Mangal and John Khoury for a discussion with BioProcess Online Chief Editor Matt Pillar to address solutions to the biotherapeutic and cell and gene therapy process and manufacturing talent gap.

BIOPHARMA'S TOP TRENDS 2020 - PROGRESS, ACCELERATED - LOOKING TOWARD 2021

• Biopharma's Top Trends 2020 - Progress, Accelerated - Looking Toward 2021

  BioProcess Online hosted a presentation on the biopharma trends that will continue impacting your facility and business in 2021—and how to address them—with BioPlan Associates, Inc.’ Eric Langer and Fujifilm Diosynth Biotechnologies’ Jonathan M Haigh, Ph.D.

• Cell & Gene Therapy Capacity Crunch
• Bioprocessing Manufacturing Productivity, Single Use Displaces Stainless In 2021
• Biopharma’s Response To The Covid-19 Pandemic