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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 we sit 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.

CHALLENGES AND CONSIDERATIONS FOR PURIFYING MULTISPECIFIC MOLECULES

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Challenges And Considerations For Purifying Multispecific Molecules

The structural complexity and variability of multispecific molecules presented purification challenges, from incorrect chain pairings to increased aggregation, fragmentation, and lower yield compared to standard mAbs. Developers shared how they overcame these challenges t...

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Characterizing Product- And Process-Related Impurities In Multispecifics

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Involve CMC And Formulations Experts Early In Process Development

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Analytics Are The Eyes Of Process Development

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Purification Strategies For Multispecifics

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Strategies For Viral Inactivation And Filtration In Multispecifics

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Addressing Manufacturability And Scalability Challenges In Multispecifics Purification

PROCESS OPTIMIZATION OR FULL-SCALE AUTOMATION?

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Process Optimization Or Full-Scale Automation?

While continuous processing often steals the spotlight with its promise of uninterrupted workflows, many seasoned professionals continue to advocate for process optimization and intensification as equally effective—and far less capital-intensive—alternatives.<...

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Are You Team Batch Fed, Or Team Continuous?

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Facilities And Capital Considerations For Continuous Manufacturing

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Validation, PAT, And AI In Fed-Batch And Continuous Environments

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Product Quality, Process Complexity, And Cost Control

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Automation Adoption In Biopharma

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A Deeper Look At Product Quality Variables

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Does Continuous Complexity Outweigh Its Benefit?

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Do Novel Workflows Increase Regulatory Scrutiny?

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MEET OUR HOSTS

 

Tyler Menichiello is Chief Editor at Bioprocess Online. He aims to investigate the industry’s most prevalent challenges and emerging best practices to provide both interesting and actionable content for industry leaders.

LINKEDIN

 

Matthew Pillar is Vice President of Editorial & Content at Life Science Connect. He's spent the past 20 years covering tech-centric industries as they’ve navigated AI, machine learning, IoT, and other emerging technologies.

LINKEDIN

ACCELERATING ADC PROCESS DEVELOPMENT

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Accelerating ADC Process Development

The rapid advancement of ADCs put the fine balance between speed to IND and robust process development to the test, especially when scaling up and transferring production.

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ADCs & Speed To IND

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AI In ADC Target Identification

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Challenges In ADC Process Development

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Linker And ADC Platform Manufacturing Technologies

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ADC Heterogeneity, Site-Specific Conjugation

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Clinical Trial Strategy And ADC Dev Partnership

IMPACT OF THE BIOSIMILARS BOOM

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Impact Of The Biosimilars Boom

With a third wave of biologics patents set to expire, the biosimilars boom is in full effect. How is patent pursuit shaping up, what manufacturing, regulatory, and market/patient access challenges must be addressed for biosimilar success, and how are the world’s lea...

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Biosimilars Are Booming: The Current Landscape

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Patient, Payer, Provider, And Pharma Perspectives On Biosimilars

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How Patient Access, Mistrust Burden Biosimilars

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Market And Policy Dynamics Impacting Biosimilars

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Biosimilars Cost Control And IP Protection

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What Threatens Biosimilars, How Partnerships Protect Them

BIOMANUFACTURING PRECISION WITH DIGITAL TWINS & MECHANISTIC MODELS

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Biomanufacturing Precision With Digital Twins & Mechanistic Models

During this Bioprocess Online Live, experts from Pfizer, Takeda, and Sanofi discussed how digital twins and mechanistic modeling improve biopharmaceutical processes and streamline new production line setups.

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Defining Digital Twins And Mechanistic Models

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Perspectives On Digital Twins And The Catalyst For Adoption

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Identifying "Killer Apps" For Digital Twins

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The Role Of AI And Data In Enhancing Digital Twins

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Organizational Limitations And Justification For Digital Twins

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Digital Twins Risks, Limitations, And Regulatory Landscape

DESIGNING TRANSFERABLE ANALYTICAL METHODS

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Designing Transferable Analytical Methods

Analytical methods should never live in a vacuum. No matter how robust and consistent your assays are today, the time will come when a tech transfer, a scale-up, a supplier change, a partnership deal, or some other force of change on the biopharma landscape requires an an...

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Defining A Good Method Development Strategy

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Balancing Quick Results And Careful Planning

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Developing Safety And Potency Assays

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Considerations For Characterization Assays And Release Testing

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Method Qualification Versus Method Validation

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Phase-Appropriate Risk Management Strategies

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Keys To A Successful Tech Transfer

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Controlling Analyst Bias

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Preparing A Gap Analysis

A REALISTIC LOOK AT AI/ML USE IN BIOMANUFACTURING

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A Realistic Look at AI/ML Use in Biomanufacturing

Artificial intelligence (AI) and machine learning (ML) are the buzzwords of the decade, often accompanied by a myriad of lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing...

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Adoption And Implementation

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AI/ML As Tools In Biomanufacturing

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Training AI Models

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Data Quality, Collection, Storage, And Security

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Process Optimization And Control

EARLY PROCESS CONSIDERATIONS FOR NOVEL PROTEIN THERAPEUTICS

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Early Process Considerations For Novel Protein Therapeutics

Complex protein-based therapies require developers to see the unforeseen and embrace new roles and responsibilities in sourcing both raw materials and outsourced expertise.

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Three Novel Protein Therapeutic Worldviews

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Cell Line Selection In Novel Protein Therapeutic Development

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Key Attributes To Monitor During Cell Line Development Of Complex Proteins

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Addressing Post-Translational Modifications In Novel Protein Therapeutics

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IND Prep Versus Clinical/Commercial Scale-Up In Novel Protein Therapeutics

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When To Conduct Analytical Assays In Novel Protein Therapeutic Development

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Addressing Aggregation And Degradation In Complex Protein Therapeutics

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Outsourcing Considerations For Novel Protein Therapeutics

NAVIGATING ADC MANUFACTURING COMPLEXITY

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Understanding Sponsor/Contractor Roles When Producing ADCs

Antibody-Drug Conjugates (ADCs) are a hot and promising commodity, and a ballooning clinical-stage ADC development community is putting stress on both manufacturing capacity, and antibody engineering and conjugation talent. What does this burgeon mean for ADC manufacturin...

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Meet The ADC Upstarts At Mythic Therapeutics And Vincerx

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Orchestrating A Multi-Part ADC Contract Manufacturing Landscape

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CMC Bottlenecks And Tech Transfer Strategy In ADC Development

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The Complex Link Between ADC CMC And The IND

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ADC Payload Preferences Revealed

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Addressing Bystander Effect & Toxicity In ADC Development

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ADC Scale-Up In A GMP Environment

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Greatest Challenges In ADC Development & Manufacturing

BIOPROCESS INTENSIFICATION IN THE REAL WORLD

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Bioprocess Intensification In The Real World

The biopharma “literature” is chock-full of big process intensification promises, but what is really achievable?

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Why AstraZeneca and AbbVie Are Intensifying Processes

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What Bioprocessing Bottlenecks Does Process Intensification Address?

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Where Process Intensification Sits In The AbbVie, AstraZeneca Organizations

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Process Intensification Audience Q&A

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Process Intensification Development Challenges At AZ and AbbVie

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What Analytics Drive Process Intensification?

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Considerations In Continuous Chromatography

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What's Next For Bioprocess Intensification?

SINGLE-USE TECHNOLOGIES FOR BIOPROCESSING: AN ESSENTIAL UPDATE

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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.

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If You CAN Go Single-Use, You WILL Go Single Use

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Single-Use, Stainless, Or Hybrid For Biomanufacturing?

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Closed-Process Support For Personalized Medicine

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Single Use Supply & Sourcing: Eliminating Risk

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From Bench To Big Bio: The Impact Of Scale On Single Use Decisions

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Genderless? Gendered? Single-Use Standards?

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Single-Use Sustainability: Plastic Is A GOOD Thing?

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Single-Use Advice, Next Steps, & More Resources

BIOPROCESS MANUFACTURING ANALYTICS & CONTROLS: NEXT GEN TECHNOLOGIES

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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?

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AI, In-Silico, Digital Twins, & Omics

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Prerequisites To Modern ATMP Biomanufacturing

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Creating Standards Where They Don't Exist

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Rapid Fire ATMP Manufacturing Efficiency Gains

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Next-Gen Sequencing, Mechanistic Modelling, & What's Missing

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Where AI And ML Fit In ATMP Manufacturing

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Does Manufacturing Complexity Warrant Tech Investment, Or Detract From It?

BIOPROCESS R&D: BEGINNING WITH THE END IN MIND

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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,...

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The R&D Approaches At Amgen & Cullinan Oncology

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Driving Efficiency From R&D To The Clinic

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AI & Creativity In Molecular Design And Target ID

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Challenges To Greenlighting Biologics R&D

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What Biopharma R&D Steps Are Ripe For Efficiency Gains?

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Countdown To Patient Impact: How Fast Can We Go?

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Faster Biopharma R&D: What Could Go Wrong?

HOW COMPUTATIONAL BIOLOGY SPEEDS DRUG DISCOVERY, DEVELOPMENT

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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.

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Meet Our Guests: EVQLV's Andrew Satz And Recursion's Tina Larson

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How Far We've Come: AI, ML Applications In Practice

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Managing The Hype: How Long Does It Take To Change The World?

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The Data Dilemma: How Much, And What Quality Drives AI Outcomes In Biotech?

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Tech Infrastructure: What It Takes To DYI Or Outsource Computational Biology

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The Marriage Of Wet Labs And Computational Biology

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Where Computation Beats Science, And Vice Versa

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Integrating Science And Computational Talent

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What's Next For Computational Biology In Biotech?

MRNA UPDATE: BEYOND PROPHYLACTIC VACCINES

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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 ...

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mRNA Therapeutics: To The Liver, And Beyond!

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Maintaining Stability: How We're Getting RNA Where It Needs To Go

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The Launch Pad: Why Platforms Matter For mRNA Therapeutic Development

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Paths To mRNA Degradation, And How To Mitigate Them

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Analytics & Assays: Defining mRNA Therapeutic Impurities Early & Often

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Optimizing mRNA Formulations In A Bottlenecked & Bifurcated Supply Chain

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Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want?

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What Indications Can, And Will, mRNA Therapeutics Address?

RISK REDUCTION IN MRNA THERAPEUTIC DEVELOPMENT

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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.

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Risk Reduction In mRNA Therapeutic Development: Meet The Panel

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Chromatography And Column-Free Processes

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Therapeutic Market Opportunities For mRNA

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Addressing Safety Risks In mRNA Therapeutics

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LNP Stability In mRNA Therapeutics

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mRNA Supply Chain And Critical Component Risks

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Novel Excipients Versus Active Substances And Inflammatory Response

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mRNA, TFF, And Next Steps To Tackle mRNA Therapeutic Challenges

PROCESS DEVELOPMENT FOR A DIVERSE MAB PIPELINE

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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.

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Multi-Specific Antibody Development: What Challenges The Need For Speed?

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Maintaining mAb Viability After The Exponential Growth Phase

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Maintaining Downstream Quality In Multi-Specific Antibody Manufacturing

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Purification Strategies For New Classes Of Antibodies

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PAT In Multi-Specific Antibody Manufacturing

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Legal & Compliance Impact On Speed In The Antibody Market

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Challenges To Developing High Concentration Formulation For Multi-Specific Antibodies

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Introducing New Technology To A Multi-Specific Antibody Line

MANUFACTURING THE 3RD BIOLOGICS REVOLUTION

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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 thera...

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Why The Cancer Vaccine Concept Is En Vogue Again

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Why Therapeutic Cancer Vaccines Haven't Worked To Date

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Capital, Manufacturing Market Acceptance Of Therapeutic Cancer Vaccines

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What Makes A Good Therapeutic Cancer Vaccine Antigen?

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Personalized Or Off The Shelf? Differentiated Approaches To Cancer Vaccines

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Maintaining Cost Efficiency In A Personalized Oncology World

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Manufacturing Challenges In Cancer Vaccine Development

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Shelf Lives & Logistics: Ensuring The Stability Of Therapeutic Cancer Vaccines

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Navigating Cancer Vaccines' Regulatory Waters

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Where Therapeutic Cancer Vaccines Go Next

SURGE MANUFACTURING FOR BIOPHARMA RESILIENCE

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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.

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Get Acquainted With Kayla Hannon And Surge Manufacturing

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Meet Dr. Zoltán Kis And The Wellcome Leap RNA R3 Program

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Post-COVID Surge Manufacturing Progress

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Hiring Up For Surge Manufacturing Capacity

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The Roles Of Automation And Monitoring In Surge Manufacturing

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mRNA's Impact On Cost And Capacity To Surge Biopharma Production

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Biomanufacturing Anywhere To Meet Demand, + Regulatory Concerns

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Where Has The Best Progress Toward Pandemic Response Happened?

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Building Biopharma Supply Chain Resilience, Cost Reduction

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Applying Pandemic Learnings To Future State Manufacturing

REVOLUTIONARY INCREMENTALISM FUTURE-PROOFING MRNA DRUG MANUFACTURING

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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.

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Assessing The Manufacturability Of Prospective Lead mRNA Candidates

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How To Foster Greater R&D And CMC Integration In Your Organization

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The Current State Of The mRNA Supply-Chain — In Brief

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Is The IVT Reaction A Coy Mistress? The Knowns & Unknowns

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Considerations To Better Understand/Mitigate Raw Material Variability

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"Continuous Improvement:" Defining Your Purification Process & Product Specifications

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Thinking Differently About The Future Of mRNA Manufacturing

DATA-DRIVEN CMC FOR PD SPEED, REGULATORY EFFICIENCY

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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 Onli...

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Where CMC Starts In Biopharma Drug Dev

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What Does CMC Infrastructure Look Like?

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The Right Tools For Data-Centric CMC

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Who's Driving Adoption Of New PD/CMC Tech?

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PD, CMC Technology: Cost And Validation

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How Advanced CMC Packages Enable Regulatory Efficiency

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Early CMC Work Impacts Regulatory Submissions

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Who's Defining CMC Requirements?

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How AI And Machine Learning Will Impact CMC

IND SUCCESS: NAVIGATE THROUGH THE REGULATORY GRAY

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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...

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Pre-IND Prep: A Primer

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Animal Testing & Tox: What's Required Today?

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Why Clinical Holds Happen

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The Impact Of The Clinical Hold

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IND Submissions Are On The Rise

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How To Avoid A Clinical Hold

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So, You've Been Put On Clinical Hold…

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Resources For Successful IND Submissions

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IND Submission Advice From The Front Lines

BIOPHARMA PAT: GATEWAY TO CONTINUOUS MANUFACTURING

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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, a...

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Who's Ready For Continuous Manufacturing?

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Can Continuous Biomanufacturing Borrow From Small Molecules?

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Applications For PAT And Continuous: Seed Trains & Data Anomalies

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Why PAT Is Foundational To Continuous Manufacturing & What Stands In The Way

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Methods To Process Intensification, Downstream Challenges In Continuous Manufacturing

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How Industry Orgs, Associations Are Supporting Continuous Manufacturing

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How Do We Quantify Continuous Manufacturing Benefits?

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Sensors & Data: What Feeds Effective Continuous Manufacturing?

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Q&A On Continuous Manufacturing In Biopharma

LNPS & BEYOND: OPPORTUNITIES IN RNA DELIVERY

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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 deliver...

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The Scientific Underpinnings Of mRNA/LNPs

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mRNA's Future Beyond The COVID Vaccines

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Q&A On Formulation & Stability Of LNPs

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Defining A "Next-Gen" LNP

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Q&A On LNP Cell-Specific Delivery

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Overcoming Regulatory, Safety/Efficacy, And Toxicity Hurdles

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Achieving mRNA-LNP Delivery Beyond The Liver

REGULATORY HARMONIZATION MEETS CMC REALITIES

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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-spec...

7:46 Taking The Regulatory Path Of Most Resistance

Taking The Regulatory Path Of Most Resistance

7:04 Which Regulations Impact CMC The Most?

Which Regulations Impact CMC The Most?

6:12 CMC Changes & Regulatory Interaction

CMC Changes & Regulatory Interaction

7:29 Q&A On ICH Q12 Guidelines

Q&A On ICH Q12 Guidelines

8:40 Comparability Assessment Protocols

Comparability Assessment Protocols

6:13 CDMO’s Role In CMC & Regulatory Considerations

CDMO's Role In CMC & Regulatory Considerations

4:46 Importance Of Cross-Functional Teams In The Regulatory/CMC Dynamic

Importance Of Cross-Functional Teams In The Regulatory/CMC Dynamic

4:00 Understanding Differences Among Global Regulatory Jurisdictions

Understanding Differences Among Global Regulatory Jurisdictions

5:14 Where Is Global Regulatory Harmonization Going From Here?

Where Is Global Regulatory Harmonization Going From Here?

OVERCOMING PLATFORM INEFFICIENCIES IN MAB MANUFACTURING

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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 developm...

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Why Efficiency Matters In mAb Manufacturing

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Impact Of Molecular, Process Complexity On mAb Manufacturing Efficiency

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Connecting Discovery, Development, And mAb Manufacturing Efficiency

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The Platform Problem: Why Legacy mAb Platforms Might Be A Liability

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mAb Production Capacity, Continuous Manufacturing, & CDMO/CMO Selection

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Managing mAb Manufacturing Risk

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What's Holding Back mAb Manufacturing Efficiencies?

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Beyond The mAb: Tech, Collaboration Drive The Future Of Antibody Manufacturing

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

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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, V...

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mRNA Manufacturing: In House Or Outsourced?

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CMC Considerations For mRNA Manufacturing

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Regulatory Concerns In mRNA Therapeutic Development

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A Q&A On CMC In mRNA Manufacturing

THE NEXT PANDEMIC: BIOPHARMA'S OPPORTUNITIES AND OBLIGATIONS

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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 p...

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Grading The Life Science Community's Pandemic Performance

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The Fundamental Role Of Public/Private Partnerships In Pandemic Response

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Public Resources For Pandemic Response Manufacturing Capacity

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Building A Task Force For Public/Private Partnership

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The Roles Of Vaccines AND Therapeutics In Pandemic Response

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The Importance Of Supply Chain, Manufacturing Resilience In Pandemic Response

MRNA MANUFACTURING: BRIGHT FUTURE, BIG CHALLENGES

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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 proph...

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Three Leaders In mRNA Therapeutics

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Process Development Challenges In mRNA Therapeutics

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Addressing mRNA's Scalability And Supply Challenges

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The Market For mRNA Vaccines & Therapeutics

BIOPROCESS AUTOMATION: TRUTH OR ILLUSION?

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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.

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BioProcess Automation: Three Leaders On Where They Stand

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What Motivates A Process Automation Investment?

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Who Champions Process Automation, And Who Runs It?

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Technical Implications, Cost Considerations Of BioProcess Automation

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The Incremental Approach To BioProcess Automation Adoption

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BioProcess Automation ROI And Next Steps

UPSTREAM PROCESS INTENSIFICATION: REAL-WORLD RESULTS

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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.

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Why Invest In Process Intensification?

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Supplier Qualification & Cost Of Perfusion Intensification

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Process Intensification: ROI Realities & Implementation Considerations

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Regulatory Considerations For Process Intensification

VACCINE MANUFACTURING & REGULATORY ADVANCES: RIDING COVID'S COATTAILS

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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 changin...

More From Vaccine Manufacturing & Regulatory Advances: Riding COVID's Coattails
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Today's Biggest Vaccine Manufacturing Challenges

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Vaccine Platforms & Platform Variables

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Will Biopharma Regulators Maintain Their Accelerated Pace?

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The Biopharma Regulatory Scene Post-COVID

GENE & RNA THERAPIES: REGULATORY REQUIREMENTS TAKE SHAPE

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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

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Forming Up A Regulatory Strategy: When And How To Start

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Regulating Personalized Therapeutics: Are There Precedents?

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Accommodating The FDA: Handling Change Management In Your Regulatory Strategy

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FDA Regulations: What's Guidance, What Are Requirements, & What Matters Most?