SINGLE-USE TECHNOLOGIES FOR BIOPROCESSING: AN ESSENTIAL UPDATE

• Single-Use Technologies For Bioprocessing

  Expert panelist describe the latest in standardization efforts around single-use in biopharma, regulatory considerations, single-use applications, supply security strategies, single-use economics, and more.

BIOPROCESS MANUFACTURING ANALYTICS & CONTROLS: NEXT GEN TECHNOLOGIES

• Bioprocess Manufacturing Analytics & Controls: Next Gen Technologies

  What analytics technologies, tools, and instruments do leading biopharmaceutical developers consider requisite in the buildout of a modern biologics/ATMP, manufacturing facility?

BIOPROCESS R&D: BEGINNING WITH THE END IN MIND

• Bioprocess R&D: Beginning With The End In Mind

  In a period marked by resource constraints, focusing R&D on the most likely molecules to succeed is paramount. But, how do you do it? On this Bioprocess Online Live event, we explored the most efficient approaches to scalable discovery, molecular screening and assays, definition of CQAs, establishing a proof of concept, and assessing developability. Bioprocess Online’s Matt Pillar as joined by Amgen VP of Research Dr. Robert Stoffel, and Cullinan Oncology President & CEO Nadim Ahmed. Available on-demand.

HOW COMPUTATIONAL BIOLOGY SPEEDS DRUG DISCOVERY, DEVELOPMENT

• How Computational Biology Speeds Drug Discovery, Development

  Check out this discussion on two approaches to adopting computational technology – do-it-yourself and outsourcing – with two of the most innovative minds in the space, EVQLV’s Andrew Satz and Recursion President and COO Tina Larson.

• Meet Our Guests: EVQLV’s Andrew Satz And Recursion’s Tina Larson
• How Far We’ve Come: AI, ML Applications In Practice
• Managing The Hype: How Long Does It Take To Change The World?
• The Data Dilemma: How Much, And What Quality Drives AI Outcomes In Biotech?
• Tech Infrastructure: What It Takes To DYI Or Outsource Computational Biology
• The Marriage Of Wet Labs And Computational Biology
• Where Computation Beats Science, And Vice Versa
• Integrating Science And Computational Talent
• What’s Next For Computational Biology In Biotech?

MRNA UPDATE: BEYOND PROPHYLACTIC VACCINES

• mRNA Update: Beyond Prophylactic Vaccines

  mRNA-based therapeutics are widely regarded as a “next big thing” in biopharma, but manufacturing them is fraught with complex challenges. Check out this digital event from Bioprocess Online Live featuring a discussion with mRNA process development experts on the front lines of the mRNA therapeutics revolution.

• mRNA Therapeutics: To The Liver, And Beyond!
• Maintaining Stability: How We’re Getting RNA Where It Needs To Go
• The Launch Pad: Why Platforms Matter For mRNA Therapeutic Development
• Paths To mRNA Degradation, And How To Mitigate Them
• Analytics & Assays: Defining mRNA Therapeutic Impurities Early & Often
• Optimizing mRNA Formulations In A Bottlenecked & Bifurcated Supply Chain
• Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want?
• What Indications Can, And Will, mRNA Therapeutics Address?

RISK REDUCTION IN MRNA THERAPEUTIC DEVELOPMENT

• Risk Reduction In mRNA Therapeutic Development

  mRNA is at an inflection point. To reach its therapeutic potential in chronic, and even rare, disease applications, some biopharmaceutical manufacturing fundamentals must be addressed.

• Risk Reduction In mRNA Therapeutic Development: Meet The Panel
• Chromatography And Column-Free Processes
• Therapeutic Market Opportunities For mRNA
• Addressing Safety Risks In mRNA Therapeutics
• LNP Stability In mRNA Therapeutics
• mRNA Supply Chain And Critical Component Risks
• Novel Excipients Versus Active Substances And Inflammatory Response
• mRNA, TFF, And Next Steps To Tackle mRNA Therapeutic Challenges

PROCESS DEVELOPMENT FOR A DIVERSE MAB PIPELINE

• Process Development For A Diverse mAb Pipeline

  Our latest Bioprocess Online Live virtual panel event covered process development advances in a diversifying mAb market (i.e. bi- and tri-specific) with leading experts in the field.

• Multi-Specific Antibody Development: What Challenges The Need For Speed?
• Maintaining mAb Viability After The Exponential Growth Phase
• Maintaining Downstream Quality In Multi-Specific Antibody Manufacturing
• Purification Strategies For New Classes Of Antibodies
• PAT In Multi-Specific Antibody Manufacturing
• Legal & Compliance Impact On Speed In The Antibody Market
• Challenges To Developing High Concentration Formulation For Multi-Specific Antibodies
• Introducing New Technology To A Multi-Specific Antibody Line

MANUFACTURING THE 3RD BIOLOGICS REVOLUTION

• Manufacturing The 3rd Biologics Revolution

  NOW ON DEMAND: HDT Bio Chief Scientific Officer Peter Berglund, Ph.D., Codagenix EVP for Oncology Johanna Kaufmann, Ph.D., and Providence Therapeutics President & Chief Technology Officer Robert Georgantas III, Ph.D. share what's next for therapeutic cancer vaccines. 

• Why The Cancer Vaccine Concept Is En Vogue Again
• Why Therapeutic Cancer Vaccines Haven’t Worked To Date
• Capital, Manufacturing Market Acceptance Of Therapeutic Cancer Vaccines
• What Makes A Good Therapeutic Cancer Vaccine Antigen?
• Personalized Or Off The Shelf? Differentiated Approaches To Cancer Vaccines
• Maintaining Cost Efficiency In A Personalized Oncology World
• Manufacturing Challenges In Cancer Vaccine Development
• Shelf Lives & Logistics: Ensuring The Stability Of Therapeutic Cancer Vaccines
• Navigating Cancer Vaccines’ Regulatory Waters
• Where Therapeutic Cancer Vaccines Go Next

SURGE MANUFACTURING FOR BIOPHARMA RESILIENCE

• Surge Manufacturing For Biopharma Resilience

  Learn what surge manufacturing is and how mobility, modularity, single-use, and process train redundancy enable the scale required of biopharmas to meet variable public health demands.

• Get Acquainted With Kayla Hannon And Surge Manufacturing
• Meet Dr. Zoltán Kis And The Wellcome Leap RNA R3 Program
• Post-COVID Surge Manufacturing Progress
• Hiring Up For Surge Manufacturing Capacity
• The Roles Of Automation And Monitoring In Surge Manufacturing
• mRNA’s Impact On Cost And Capacity To Surge Biopharma Production
• Biomanufacturing Anywhere To Meet Demand, + Regulatory Concerns
• Where Has The Best Progress Toward Pandemic Response Happened?
• Building Biopharma Supply Chain Resilience, Cost Reduction
• Applying Pandemic Learnings To Future State Manufacturing

REVOLUTIONARY INCREMENTALISM FUTURE-PROOFING MRNA DRUG MANUFACTURING

• Revolutionary Incrementalism: Future-Proofing mRNA Drug Manufacturing

  Industry experts share go-to best practices, suggestions, and experiences for prioritizing and streamlining technical operations endeavors to prepare mRNA therapeutics companies for the clinic and, eventually, the commercial market.

• Assessing The Manufacturability Of Prospective Lead mRNA Candidates
• How To Foster Greater R&D And CMC Integration In Your Organization
• The Current State Of The mRNA Supply-Chain — In Brief
• Is The IVT Reaction A Coy Mistress? The Knowns & Unknowns
• Considerations To Better Understand/Mitigate Raw Material Variability
• “Continuous Improvement:” Defining Your Purification Process & Product Specifications
• Thinking Differently About The Future Of mRNA Manufacturing

DATA-DRIVEN CMC FOR PD SPEED, REGULATORY EFFICIENCY

• Data-Driven CMC For PD Speed, Regulatory Efficiency

  CMC sits at the heart of drug development and delivery efficiency, and it's becoming ever more dependent on a digitized, analytically-driven feedback loop. Veteran biopharma technology and CMC leaders, Brian Kirk, Ph.D. and Blair McNeill, Ph.D., joined Bioprocess Online Live host, Matt Pillar, for an interactive discussion on building data-centric CMC packages that support efficiency from the outset of the development, manufacturing, and regulatory processes. This webinar is available on-demand thanks to the support of Entegris.

• Where CMC Starts In Biopharma Drug Dev
• What Does CMC Infrastructure Look Like?
• The Right Tools For Data-Centric CMC
• Who’s Driving Adoption Of New PD/CMC Tech?
• PD, CMC Technology: Cost And Validation
• How Advanced CMC Packages Enable Regulatory Efficiency
• Early CMC Work Impacts Regulatory Submissions
• Who's Defining CMC Requirements?
• How AI And Machine Learning Will Impact CMC

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!

• Pre-IND Prep: A Primer
• Animal Testing & Tox: What’s Required Today?
• Why Clinical Holds Happen
• The Impact Of The Clinical Hold
• IND Submissions Are On The Rise
• How To Avoid A Clinical Hold
• So, You’ve Been Put On Clinical Hold…
• Resources For Successful IND Submissions
• IND Submission Advice From The Front Lines

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