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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.