Welcome to Bioprocess Online Live – An interactive forum to discuss some of the most important technologies and trends impacting the biotherapeutic space.
Throughout the year, our Chief Editor, Matthew Pillar, sits down with industry experts to discuss how biopharmaceutical companies are tackling the biggest bioprocess challenges they face in the development and manufacturing of biologic therapies. These discussions often include Q&A sessions with attendees, and each Bioprocess Online Live session is archived and accessible at any time by registered site users.
MANUFACTURING THE 3RD BIOLOGICS REVOLUTION
Manufacturing The 3rd Biologics Revolution
While low immunogenicity, established disease burden, and the immunosuppressive tumor microenvironment have proven early development challenges, the therapeutic vaccine revolution is happening now, and it's gaining steam on the back of advances in RNA technology.
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
- Think 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.
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.
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.
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.
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.
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.
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.