IND SUCCESS: NAVIGATE THROUGH THE REGULATORY GRAY

• IND Success: Navigate Through The Regulatory Gray

  Umoja Biopharma VP, Regulatory Affairs Helen Kim and NDA Partners' Expert Consultant Daniela Drago dig into the most common reasons for clinical holds, offer tips for avoiding and addressing them, and share best practices and resources for IND preparation in this special edition of Bioprocess Online Live!

BIOPHARMA PAT: GATEWAY TO CONTINUOUS MANUFACTURING

• Biopharma PAT: Gateway To Continuous Manufacturing

  Join Paul Testa, EVP of Supply Chain and Operations at Kyowa Kirin North America and Barrett Fallentine, Director, Process & Product Development at Pharmatech Associates to learn what process analytical technology is enabling, the efficiencies it's driving, and the role it's playing as early adopters work ever closer to continuous biopharmaceutical manufacturing.

• Who’s Ready For Continuous Manufacturing?
• Can Continuous Biomanufacturing Borrow From Small Molecules?
• Applications For PAT and Continuous: Seed Trains & Data Anomalies
• Why PAT Is Foundational To Continuous Manufacturing & What Stands In The Way
• Methods to Process Intensification, Downstream Challenges In Continuous Manufacturing
• How Industry Orgs, Associations Are Supporting Continuous Manufacturing
• How Do We Quantify Continuous Manufacturing Benefits?
• Sensors & Data: What Feeds Effective Continuous Manufacturing?
• Q&A On Continuous Manufacturing In Biopharma

LNPS & BEYOND: OPPORTUNITIES IN RNA DELIVERY

• LNPs & Beyond: Opportunities In RNA Delivery

  The rapid development, scale-up, and successful commercialization of mRNA vaccines served as a great case study on the importance of mRNA/RNA therapeutics. For those striving to develop next-gen RNA therapeutics, achieving more specifically targeted non-viral delivery is a large hurdle to broadening their applicability, durability, and effectiveness.

• The Scientific Underpinnings of mRNA/LNPs
• mRNA’s Future Beyond The COVID Vaccines
• Q&A on Formulation & Stability of LNPs
• Defining A “Next-Gen” LNP
• Q&A on LNP Cell-Specific Delivery
• Overcoming Regulatory, Safety/Efficacy, and Toxicity Hurdles
• Achieving mRNA-LNP Delivery Beyond the Liver

REGULATORY HARMONIZATION MEETS CMC REALITIES

• Regulatory Harmonization Meets CMC Realities

  For developers and manufacturers of biopharmaceuticals with international commercialization intentions, the concepts of regulatory harmonization and convergence sound like sunshine and roses. For CMC teams challenged to keep stride with shapeshifting and jurisdiction-specific changes, maybe not so much.

• Taking The Regulatory Path Of Most Resistance
• Which Regulations Impact CMC The Most?
• CMC Changes & Regulatory Interaction
• Q&A On ICH Q12 Guidelines
• Comparability Assessment Protocols
• CDMO’s Role In CMC & Regulatory Considerations
• Importance Of Cross-Functional Teams In The Regulatory/CMC Dynamic
• Understanding Differences Among Global Regulatory Jurisdictions
• Where Is Global Regulatory Harmonization Going From Here?

OVERCOMING PLATFORM INEFFICIENCIES IN MAB MANUFACTURING

• Overcoming Platform Inefficiencies In mAb Manufacturing

  Gene Lee, Ph.D., Chief Technical Officer at AltruBio and Avril Vermunt, Sr. Director of Manufacturing Sciences and Technology at EQRx joined Matt Pillar, Chief Editor at Bioprocess Online to address how innovative biopharmas are manipulating process development and manufacturing protocols to drive efficiencies and cost controls.

• Why Efficiency Matters In mAb Manufacturing
• Impact Of Molecular, Process Complexity On mAb Manufacturing Efficiency
• Connecting Discovery, Development, And mAb Manufacturing Efficiency
• The Platform Problem: Why Legacy mAb Platforms Might Be A Liability
• mAb Production Capacity, Continuous Manufacturing, & CDMO/CMO Selection
• Managing mAb Manufacturing Risk
• What’s Holding Back mAb Manufacturing Efficiencies?
• Beyond The mAb: Tech, Collaboration Drive The Future Of Antibody Manufacturing

CMC, SCALE UP, & THE ROAD TO MRNA REGULATORY APPROVAL

• CMC, Scale Up, & The Road To mRNA Regulatory Approval

  Check out part two of our Bioprocess Online Live series on mRNA manufacturing challenges and opportunities. The panel discussion features Dr. Akhilesh Bhambhani, Sr. Director, Biologics Drug Product Development at Ultragenyx Pharmaceuticals and Roberta Duncan, VP and mRNA Program Lead at Seqirus. These two experts discuss some of the most critical steps to mRNA vaccine and therapeutic commercialization, including CMC, scale-up, tech transfer, and regulatory strategy.

• mRNA Manufacturing: In House Or Outsourced?
• CMC Considerations For mRNA Manufacturing
• Regulatory Concerns In mRNA Therapeutic Development
• A Q&A On CMC In mRNA Manufacturing

THE NEXT PANDEMIC: BIOPHARMA'S OPPORTUNITIES AND OBLIGATIONS

• The Next Pandemic: Biopharma's Opportunities and Obligations

  Bioprocess Online Live hosted an interactive discussion with Heat Biologics Founder & CEO Jeff Wolf, Massachusetts Biomedical Initiatives President & CEO Jon Weaver and Lakes BioScience Chief Strategy and Technology Officer Adrian Wallis on the role and value of public/private partnership in developing platforms for pandemic preparedness. Check out this On-Demand version where we explored the collaborations enabling agile response to public health emergencies, therapeutic manufacturing flexibility, vaccine platform development, and supply chain resiliency.

• Grading The Life Science Community’s Pandemic Performance
• The Fundamental Role Of Public/Private Partnerships In Pandemic Response
• Public Resources For Pandemic Response Manufacturing Capacity
• Building A Task Force For Public/Private Partnership
• The Roles Of Vaccines AND Therapeutics In Pandemic Response
• The Importance Of Supply Chain, Manufacturing Resilience In Pandemic Response

MRNA MANUFACTURING: BRIGHT FUTURE, BIG CHALLENGES

• mRNA Manufacturing: Bright Future, Big Challenges

  The rapid development of mRNA vaccines demonstrates the potential of the technology's breadth, speed, and scale, but manufacturing hurdles and bottlenecks remain. Biopharma executives on the front lines share the manufacturing efficiencies required to enable the prophylactic and therapeutic potential of mRNA technology.

• Three Leaders In mRNA Therapeutics
• Process Development Challenges In mRNA Therapeutics
• Addressing mRNA’s Scalability And Supply Challenges
• The Market For mRNA Vaccines & Therapeutics

BIOPROCESS AUTOMATION: TRUTH OR ILLUSION?

• Bioprocess Automation: Truth Or Illusion?

  Join iBio COO Randy Maddux, Kyowa Kirin EVP Paul Testa, and Sutro Biopharma VP Devendra Luhar for a spirited discussion on aversions to and advantages of biopharma manufacturing automation.

• BioProcess Automation: Three Leaders On Where They Stand
• What Motivates A Process Automation Investment?
• Who Champions Process Automation, And Who Runs It?
• Technical Implications, Cost Considerations Of BioProcess Automation
• The Incremental Approach To BioProcess Automation Adoption
• BioProcess Automation ROI And Next Steps

UPSTREAM PROCESS INTENSIFICATION: REAL-WORLD RESULTS

• Upstream Process Intensification: Real-World Results

  Join Sonnet BioTherapeutics CTO Susan Dexter, single-use/process intensification pioneer Parrish Galliher, and Matt Pillar 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?
• The Biopharma Regulatory Scene Post-COVID

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