21_01_BioprocessLive_SiteHeader


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.

PROCESS OPTIMIZATION OR FULL-SCALE AUTOMATION?

59:40 25_04_BPOL_1280x720_Video
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.<...

ACCELERATING ADC PROCESS DEVELOPMENT

1:02:41 25_03_BPOL_1280x720_Vid
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.

9:14 25_03_BPOL_1280x720_Seg01

ADCs & Speed To IND

12:12 25_03_BPOL_1280x720_Seg02

AI In ADC Target Identification

8:59 25_03_BPOL_1280x720_Seg03

Challenges In ADC Process Development

9:37 25_03_BPOL_1280x720_Seg04

Linker And ADC Platform Manufacturing Technologies

16:27 25_03_BPOL_1280x720_Seg05

ADC Heterogeneity, Site-Specific Conjugation

6:59 25_03_BPOL_1280x720_Seg06

Clinical Trial Strategy And ADC Dev Partnership

IMPACT OF THE BIOSIMILARS BOOM

1:03:23 25_02_BPOL_1280x720_Vid
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...

11:48 25_02_BPOL_1280x720_Seg01

Biosimilars Are Booming: The Current Landscape

13:13 25_02_BPOL_1280x720_Seg02

Patient, Payer, Provider, And Pharma Perspectives On Biosimilars

5:18 25_02_BPOL_1280x720_Seg03

How Patient Access, Mistrust Burden Biosimilars

9:32 25_02_BPOL_1280x720_Seg04

Market And Policy Dynamics Impacting Biosimilars

10:54 25_02_BPOL_1280x720_Seg05

Biosimilars Cost Control And IP Protection

12:46 25_02_BPOL_1280x720_Seg06

What Threatens Biosimilars, How Partnerships Protect Them

BIOMANUFACTURING PRECISION WITH DIGITAL TWINS & MECHANISTIC MODELS

1:08:55 25_01_BPOL_1920x1080
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.

5:31 25_01_BPOL_1920x1080_Seg01

Defining Digital Twins And Mechanistic Models

10:36 25_01_BPOL_1920x1080_Seg02

Perspectives On Digital Twins And The Catalyst For Adoption

7:13 25_01_BPOL_1920x1080_Seg03

Identifying "Killer Apps" For Digital Twins

16:02 25_01_BPOL_1920x1080_Seg04

The Role Of AI And Data In Enhancing Digital Twins

18:41 25_01_BPOL_1920x1080_Seg05

Organizational Limitations And Justification For Digital Twins

10:47 25_01_BPOL_1920x1080_Seg06

Digital Twins Risks, Limitations, And Regulatory Landscape

25_05_BPOL_300x250

MEET OUR HOSTS

 

Matthew Pillar is chief editor at Bioprocess Online. He's spent the past 20 years covering tech-centric industries as they’ve navigated AI, machine learning, IoT, and other emerging technologies.

LINKEDIN

 

Tyler Menichiello is a contributing editor to Bioprocess Online, Cell & Gene, and Clinical Leader. 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

DESIGNING TRANSFERABLE ANALYTICAL METHODS

59:51 24_12_BPOL_1920x1080
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...

17:41 24_12_BPOL_1920x1080_Seg01

Defining A Good Method Development Strategy

6:01 24_12_BPOL_1920x1080_Seg02

Balancing Quick Results And Careful Planning

9:27 24_12_BPOL_1920x1080_Seg03

Developing Safety And Potency Assays

4:16 24_12_BPOL_1920x1080_Seg04

Considerations For Characterization Assays And Release Testing

3:43 24_12_BPOL_1920x1080_Seg05

Method Qualification Versus Method Validation

1:13 24_12_BPOL_1920x1080_Seg06

Phase-Appropriate Risk Management Strategies

7:45 24_12_BPOL_1920x1080_Seg07

Keys To A Successful Tech Transfer

1:04 24_12_BPOL_1920x1080_Seg08

Controlling Analyst Bias

5:14 24_12_BPOL_1920x1080_Seg09

Preparing A Gap Analysis

A REALISTIC LOOK AT AI/ML USE IN BIOMANUFACTURING

1:00:44 24_09_BPOL_1920x1080
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...

4:00 24_09_BPOL_1280x720_Seg05

Adoption And Implementation

14:27 24_09_BPOL_1280x720_Seg01

AI/ML As Tools In Biomanufacturing

13:01 24_09_BPOL_1280x720_Seg02

Training AI Models

21:10 24_09_BPOL_1280x720_Seg03

Data Quality, Collection, Storage, And Security

6:42 24_09_BPOL_1280x720_Seg04

Process Optimization And Control

EARLY PROCESS CONSIDERATIONS FOR NOVEL PROTEIN THERAPEUTICS

1:04:29 24_08_BPOL_1920x1080
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.

6:15 24_08_BPOL_1280x720_Seg01

Three Novel Protein Therapeutic Worldviews

8:06 24_08_BPOL_1280x720_Seg02

Cell Line Selection In Novel Protein Therapeutic Development

7:03 24_08_BPOL_1280x720_Seg03

Key Attributes To Monitor During Cell Line Development Of Complex Proteins

4:13 24_08_BPOL_1280x720_Seg04

Addressing Post-Translational Modifications In Novel Protein Therapeutics

10:52 24_08_BPOL_1280x720_Seg05

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

4:45 24_08_BPOL_1280x720_Seg06

When To Conduct Analytical Assays In Novel Protein Therapeutic Development

11:13 24_08_BPOL_1280x720_Seg07

Addressing Aggregation And Degradation In Complex Protein Therapeutics

12:31 24_08_BPOL_1280x720_Seg08

Outsourcing Considerations For Novel Protein Therapeutics

NAVIGATING ADC MANUFACTURING COMPLEXITY

1:05:14 24_07_BPOL_1920x1080
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...

11:47 24_07_BPOL_1920x1080_Seg01

Meet The ADC Upstarts At Mythic Therapeutics And Vincerx

6:47 24_07_BPOL_1920x1080_Seg02

Orchestrating A Multi-Part ADC Contract Manufacturing Landscape

14:43 24_07_BPOL_1920x1080_Seg03

CMC Bottlenecks And Tech Transfer Strategy In ADC Development

4:48 24_07_BPOL_1920x1080_Seg04

The Complex Link Between ADC CMC And The IND

3:30 24_07_BPOL_1920x1080_Seg05

ADC Payload Preferences Revealed

4:44 24_07_BPOL_1920x1080_Seg06

Addressing Bystander Effect & Toxicity In ADC Development

5:03 24_07_BPOL_1920x1080_Seg07

ADC Scale-Up In A GMP Environment

10:45 24_07_BPOL_1920x1080_Seg08

Greatest Challenges In ADC Development & Manufacturing

BIOPROCESS INTENSIFICATION IN THE REAL WORLD

1:03:32 24_06_BPOL_OD_1920x1080
Bioprocess Intensification In The Real World

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

9:38 24_06_BPOL_1280x720_Seg01

Why AstraZeneca and AbbVie Are Intensifying Processes

4:11 24_06_BPOL_1280x720_Seg02

What Bioprocessing Bottlenecks Does Process Intensification Address?

4:59 24_06_BPOL_1280x720_Seg03

Where Process Intensification Sits In The AbbVie, AstraZeneca Organizations

13:33 24_06_BPOL_1280x720_Seg04

Process Intensification Audience Q&A

6:37 24_06_BPOL_1280x720_Seg05

Process Intensification Development Challenges At AZ and AbbVie

7:10 24_06_BPOL_1280x720_Seg06

What Analytics Drive Process Intensification?

8:56 24_06_BPOL_1280x720_Seg07

Considerations In Continuous Chromatography

3:59 24_06_BPOL_1280x720_Seg08

What's Next For Bioprocess Intensification?

SINGLE-USE TECHNOLOGIES FOR BIOPROCESSING: AN ESSENTIAL UPDATE

1:07:55 24_04_BPL_SingleUse_Webinar_1920x1080
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.

7:21 24_04_BPL_SingleUse_Webinar_1920x1080_01

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

8:22 24_04_BPL_SingleUse_Webinar_1920x1080_02

Single-Use, Stainless, Or Hybrid For Biomanufacturing?

5:56 24_04_BPL_SingleUse_Webinar_1920x1080_03

Closed-Process Support For Personalized Medicine

6:24 24_04_BPL_SingleUse_Webinar_1920x1080_04

Single Use Supply & Sourcing: Eliminating Risk

8:08 24_04_BPL_SingleUse_Webinar_1920x1080_05

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

13:21 24_04_BPL_SingleUse_Webinar_1920x1080_06

Genderless? Gendered? Single-Use Standards?

9:48 24_04_BPL_SingleUse_Webinar_1920x1080_07

Single-Use Sustainability: Plastic Is A GOOD Thing?

8:54 24_04_BPL_SingleUse_Webinar_1920x1080_08

Single-Use Advice, Next Steps, & More Resources

BIOPROCESS MANUFACTURING ANALYTICS & CONTROLS: NEXT GEN TECHNOLOGIES

1:01:13 24_03_BPL_Tech_Webinar_1920x1080
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?

5:49 24_03_BPL_Tech_Webinar_1920x1080_Seg01

AI, In-Silico, Digital Twins, & Omics

9:46 24_03_BPL_Tech_Webinar_1920x1080_Seg02

Prerequisites To Modern ATMP Biomanufacturing

2:10 24_03_BPL_Tech_Webinar_1920x1080_Seg03

Creating Standards Where They Don't Exist

11:39 24_03_BPL_Tech_Webinar_1920x1080_Seg04

Rapid Fire ATMP Manufacturing Efficiency Gains

8:38 24_03_BPL_Tech_Webinar_1920x1080_Seg05

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

5:13 24_03_BPL_Tech_Webinar_1920x1080_Seg06

Where AI And ML Fit In ATMP Manufacturing

12:23 24_03_BPL_Tech_Webinar_1920x1080_Seg07

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

BIOPROCESS R&D: BEGINNING WITH THE END IN MIND

1:03:50 24_01_BPL_R&D_Webinar_1920x1080
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,...

8:40 24_01_BPL_R&D_Segments_1920x1080_01

The R&D Approaches At Amgen & Cullinan Oncology

6:04 24_01_BPL_R&D_Segments_1920x1080_02

Driving Efficiency From R&D To The Clinic

9:20 24_01_BPL_R&D_Segments_1920x1080_03

AI & Creativity In Molecular Design And Target ID

11:00 24_01_BPL_R&D_Segments_1920x1080_04

Challenges To Greenlighting Biologics R&D

5:25 24_01_BPL_R&D_Segments_1920x1080_05

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

11:41 24_01_BPL_R&D_Segments_1920x1080_06

Countdown To Patient Impact: How Fast Can We Go?

7:35 24_01_BPL_R&D_Segments_1920x1080_07

Faster Biopharma R&D: What Could Go Wrong?

HOW COMPUTATIONAL BIOLOGY SPEEDS DRUG DISCOVERY, DEVELOPMENT

1:07:13 23_12_BPL_AI_Webinar_1920x1080
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.

6:21 23_12_BPL_AI_Webinar_Seg01

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

9:17 23_12_BPL_AI_Webinar_Seg02

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

5:59 23_12_BPL_AI_Webinar_Seg03

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

8:23 23_12_BPL_AI_Webinar_Seg04

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

12:43 23_12_BPL_AI_Webinar_Seg05

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

5:25 23_12_BPL_AI_Webinar_Seg06

The Marriage Of Wet Labs And Computational Biology

6:17 23_12_BPL_AI_Webinar_Seg07

Where Computation Beats Science, And Vice Versa

5:45 23_12_BPL_AI_Webinar_Seg08

Integrating Science And Computational Talent

4:32 23_12_BPL_AI_Webinar_Seg09

What's Next For Computational Biology In Biotech?

MRNA UPDATE: BEYOND PROPHYLACTIC VACCINES

1:01:01 23_10_BPL_mRNA_Webinar_1920x1080
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 ...

7:15 23_10_BPL_mRNA_Webinar_1920x1080_Seg01

mRNA Therapeutics: To The Liver, And Beyond!

9:34 23_10_BPL_mRNA_Webinar_1920x1080_Seg02

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

3:54 23_10_BPL_mRNA_Webinar_1920x1080_Seg03

The Launch Pad: Why Platforms Matter For mRNA Therapeutic Development

2:34 23_10_BPL_mRNA_Webinar_1920x1080_Seg04

Paths To mRNA Degradation, And How To Mitigate Them

6:21 23_10_BPL_mRNA_Webinar_1920x1080_Seg05

Analytics & Assays: Defining mRNA Therapeutic Impurities Early & Often

6:16 23_10_BPL_mRNA_Webinar_1920x1080_Seg06

Optimizing mRNA Formulations In A Bottlenecked & Bifurcated Supply Chain

8:41 23_10_BPL_mRNA_Webinar_1920x1080_Seg07

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

15:53 23_10_BPL_mRNA_Webinar_1920x1080_Seg08

What Indications Can, And Will, mRNA Therapeutics Address?

RISK REDUCTION IN MRNA THERAPEUTIC DEVELOPMENT

1:05:00 23_09_mRNADev_Webinar_1920x1080
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.

8:19 23_09_mRNADev_Webinar_Seg01

Risk Reduction In mRNA Therapeutic Development: Meet The Panel

4:41 23_09_mRNADev_Webinar_Seg02

Chromatography And Column-Free Processes

5:51 23_09_mRNADev_Webinar_Seg03

Therapeutic Market Opportunities For mRNA

7:17 23_09_mRNADev_Webinar_Seg04

Addressing Safety Risks In mRNA Therapeutics

4:08 23_09_mRNADev_Webinar_Seg05

LNP Stability In mRNA Therapeutics

9:45 23_09_mRNADev_Webinar_Seg06

mRNA Supply Chain And Critical Component Risks

5:41 23_09_mRNADev_Webinar_Seg07

Novel Excipients Versus Active Substances And Inflammatory Response

13:41 23_09_mRNADev_Webinar_Seg08

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

PROCESS DEVELOPMENT FOR A DIVERSE MAB PIPELINE

1:03:09 23_07_BPL_mAbPipeline_Webinar_1920x1080
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.

13:20 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg1

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

3:16 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg2

Maintaining mAb Viability After The Exponential Growth Phase

11:08 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg3

Maintaining Downstream Quality In Multi-Specific Antibody Manufacturing

3:05 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg4

Purification Strategies For New Classes Of Antibodies

4:46 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg5

PAT In Multi-Specific Antibody Manufacturing

5:33 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg6

Legal & Compliance Impact On Speed In The Antibody Market

7:37 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg7

Challenges To Developing High Concentration Formulation For Multi-Specific Antibodies

7:48 23_07_BPL_mAbPipeline_Webinar_1920x1080_Seg8

Introducing New Technology To A Multi-Specific Antibody Line

MANUFACTURING THE 3RD BIOLOGICS REVOLUTION

1:13:10 23_05_BPL_MfgRev_Webinar_1920x1080
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...

9:54 23_05_BPL_MfgRev_Webinar_Seg01

Why The Cancer Vaccine Concept Is En Vogue Again

5:35 23_05_BPL_MfgRev_Webinar_Seg02

Why Therapeutic Cancer Vaccines Haven't Worked To Date

5:07 23_05_BPL_MfgRev_Webinar_Seg03

Capital, Manufacturing Market Acceptance Of Therapeutic Cancer Vaccines

8:08 23_05_BPL_MfgRev_Webinar_Seg04

What Makes A Good Therapeutic Cancer Vaccine Antigen?

8:13 23_05_BPL_MfgRev_Webinar_Seg05

Personalized Or Off The Shelf? Differentiated Approaches To Cancer Vaccines

3:50 23_05_BPL_MfgRev_Webinar_Seg06

Maintaining Cost Efficiency In A Personalized Oncology World

11:09 23_05_BPL_MfgRev_Webinar_Seg07

Manufacturing Challenges In Cancer Vaccine Development

5:19 23_05_BPL_MfgRev_Webinar_Seg08

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

7:25 23_05_BPL_MfgRev_Webinar_Seg09

Navigating Cancer Vaccines' Regulatory Waters

6:24 23_05_BPL_MfgRev_Webinar_Seg10

Where Therapeutic Cancer Vaccines Go Next

SURGE MANUFACTURING FOR BIOPHARMA RESILIENCE

1:04:15 23_04_BPL_SurgeMfg_Webinar_1920x1080
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.

7:53 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg1

Get Acquainted With Kayla Hannon And Surge Manufacturing

4:51 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg2

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

5:00 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg3

Post-COVID Surge Manufacturing Progress

9:51 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg4

Hiring Up For Surge Manufacturing Capacity

4:18 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg4

The Roles Of Automation And Monitoring In Surge Manufacturing

8:25 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg6

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

9:24 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg7

Biomanufacturing Anywhere To Meet Demand, + Regulatory Concerns

2:18 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg8

Where Has The Best Progress Toward Pandemic Response Happened?

8:29 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg9

Building Biopharma Supply Chain Resilience, Cost Reduction

2:44 23_04_BPL_SurgeMfg_Webinar_1920x1080_Seg10

Applying Pandemic Learnings To Future State Manufacturing

REVOLUTIONARY INCREMENTALISM FUTURE-PROOFING MRNA DRUG MANUFACTURING

1:00:05 23_03_BPL_mRNA_Webinar_1200x628_OD
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.

6:08 23_03_BPL_mRNA_Webinar_1920x1080_Seg01

Assessing The Manufacturability Of Prospective Lead mRNA Candidates

7:53 23_03_BPL_mRNA_Webinar_1920x1080_Seg02

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

3:50 23_03_BPL_mRNA_Webinar_1920x1080_Seg03

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

7:24 23_03_BPL_mRNA_Webinar_1920x1080_Seg04

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

6:18 23_03_BPL_mRNA_Webinar_1920x1080_Seg05

Considerations To Better Understand/Mitigate Raw Material Variability

9:05 23_03_BPL_mRNA_Webinar_1920x1080_Seg06

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

4:34 23_03_BPL_mRNA_Webinar_1920x1080_Seg07

Thinking Differently About The Future Of mRNA Manufacturing

DATA-DRIVEN CMC FOR PD SPEED, REGULATORY EFFICIENCY

1:09:30 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_OD
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...

6:39 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg01

Where CMC Starts In Biopharma Drug Dev

6:42 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg02

What Does CMC Infrastructure Look Like?

10:47 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg03

The Right Tools For Data-Centric CMC

8:24 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg04

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

4:50 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg05

PD, CMC Technology: Cost And Validation

4:21 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg06

How Advanced CMC Packages Enable Regulatory Efficiency

12:09 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg07

Early CMC Work Impacts Regulatory Submissions

5:44 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg08

Who's Defining CMC Requirements?

9:29 23_02_BPL_DataDrivenCMC_Webinar_1920x1080_Seg09

How AI And Machine Learning Will Impact CMC

IND SUCCESS: NAVIGATE THROUGH THE REGULATORY GRAY

1:04:56 23_01_BPL_RegWebinar_1920x1080
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...

10:20 23_01_BPL_RegWebinar_1920x1080_Seg01

Pre-IND Prep: A Primer

3:52 23_01_BPL_RegWebinar_1920x1080_Seg02

Animal Testing & Tox: What's Required Today?

7:20 23_01_BPL_RegWebinar_1920x1080_Seg03

Why Clinical Holds Happen

5:01 23_01_BPL_RegWebinar_1920x1080_Seg04

The Impact Of The Clinical Hold

3:59 23_01_BPL_RegWebinar_1920x1080_Seg05

IND Submissions Are On The Rise

6:24 23_01_BPL_RegWebinar_1920x1080_Seg06

How To Avoid A Clinical Hold

9:38 23_01_BPL_RegWebinar_1920x1080_Seg07

So, You've Been Put On Clinical Hold…

5:44 23_01_BPL_RegWebinar_1920x1080_Seg08

Resources For Successful IND Submissions

13:02 23_01_BPL_RegWebinar_1920x1080_Seg09

IND Submission Advice From The Front Lines

BIOPHARMA PAT: GATEWAY TO CONTINUOUS MANUFACTURING

1:04:17 22_10_BPL_PAT_Webinar_1920x1080
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...

9:22 22_10_BPL_PAT_Webinar_1920x1080_Seg01

Who's Ready For Continuous Manufacturing?

4:24 22_10_BPL_PAT_Webinar_1920x1080_Seg02

Can Continuous Biomanufacturing Borrow From Small Molecules?

4:49 22_10_BPL_PAT_Webinar_1920x1080_Seg03

Applications For PAT And Continuous: Seed Trains & Data Anomalies

6:19 22_10_BPL_PAT_Webinar_1920x1080_Seg04

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

3:48 22_10_BPL_PAT_Webinar_1920x1080_Seg05

Methods To Process Intensification, Downstream Challenges In Continuous Manufacturing

3:26 22_10_BPL_PAT_Webinar_1920x1080_Seg06

How Industry Orgs, Associations Are Supporting Continuous Manufacturing

6:39 22_10_BPL_PAT_Webinar_1920x1080_Seg07

How Do We Quantify Continuous Manufacturing Benefits?

12:16 22_10_BPL_PAT_Webinar_1920x1080_Seg08

Sensors & Data: What Feeds Effective Continuous Manufacturing?

11:04 22_10_BPL_PAT_Webinar_1920x1080_Seg09

Q&A On Continuous Manufacturing In Biopharma

LNPS & BEYOND: OPPORTUNITIES IN RNA DELIVERY

59:23 22_10_BPL_LNP_Webinar_1920x1080
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...

6:38 22_10_BPL_LNP_Webinar_1920x1080_Seg1

The Scientific Underpinnings Of mRNA/LNPs

8:25 22_10_BPL_LNP_Webinar_1920x1080_Seg2

mRNA's Future Beyond The COVID Vaccines

4:14 22_10_BPL_LNP_Webinar_1920x1080_Seg3

Q&A On Formulation & Stability Of LNPs

8:29 22_10_BPL_LNP_Webinar_1920x1080_Seg4

Defining A "Next-Gen" LNP

3:27 22_10_BPL_LNP_Webinar_1920x1080_Seg5

Q&A On LNP Cell-Specific Delivery

8:28 22_10_BPL_LNP_Webinar_1920x1080_Seg6

Overcoming Regulatory, Safety/Efficacy, And Toxicity Hurdles

12:26 22_10_BPL_LNP_Webinar_1920x1080_Seg7

Achieving mRNA-LNP Delivery Beyond The Liver

REGULATORY HARMONIZATION MEETS CMC REALITIES

1:10:29 22_08_BPL_RegCMCWebinar_1920x1080
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

1:02:37 22_06_BPL_UpstreamEffic_Webinar_1920x1080
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...

10:42 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg01

Why Efficiency Matters In mAb Manufacturing

7:43 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg02

Impact Of Molecular, Process Complexity On mAb Manufacturing Efficiency

6:24 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg03

Connecting Discovery, Development, And mAb Manufacturing Efficiency

6:19 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg04

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

10:24 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg05

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

4:57 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg06

Managing mAb Manufacturing Risk

8:12 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg07

What's Holding Back mAb Manufacturing Efficiencies?

6:55 22_06_BPL_UpstreamEffic_Webinar_1920x1080_Seg08

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

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

1:20:48 22_03_BPL_mRNARegulatoryWebinar_1920x1080_Splashscreen
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...

8:07 22_03_BPL_mRNARegulatoryWebinar_1920x1080_Seg01

mRNA Manufacturing: In House Or Outsourced?

8:43 22_03_BPL_mRNARegulatoryWebinar_1920x1080_Seg02

CMC Considerations For mRNA Manufacturing

16:56 22_03_BPL_mRNARegulatoryWebinar_1920x1080_Seg03

Regulatory Concerns In mRNA Therapeutic Development

24:04 22_03_BPL_mRNARegulatoryWebinar_1920x1080_Seg04

A Q&A On CMC In mRNA Manufacturing

THE NEXT PANDEMIC: BIOPHARMA'S OPPORTUNITIES AND OBLIGATIONS

1:05:30 22_02_BPL_PandemicWebinar_1920x1080
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...

14:16 22_02_BPL_PandemicWebinar_1920x1080_Seg01

Grading The Life Science Community's Pandemic Performance

11:34 22_02_BPL_PandemicWebinar_1920x1080_Seg02

The Fundamental Role Of Public/Private Partnerships In Pandemic Response

4:56 22_02_BPL_PandemicWebinar_1920x1080_Seg03

Public Resources For Pandemic Response Manufacturing Capacity

9:36 22_02_BPL_PandemicWebinar_1920x1080_Seg04

Building A Task Force For Public/Private Partnership

9:34 22_02_BPL_PandemicWebinar_1920x1080_Seg05

The Roles Of Vaccines AND Therapeutics In Pandemic Response

13:04 22_02_BPL_PandemicWebinar_1920x1080_Seg06

The Importance Of Supply Chain, Manufacturing Resilience In Pandemic Response

MRNA MANUFACTURING: BRIGHT FUTURE, BIG CHALLENGES

1:01:03 mrna
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...

13:49 21_10_BPL_mRNAWebinar_1920x1080_Seg01

Three Leaders In mRNA Therapeutics

6:15 21_10_BPL_mRNAWebinar_1920x1080_Seg02

Process Development Challenges In mRNA Therapeutics

9:57 21_10_BPL_mRNAWebinar_1920x1080_Seg03

Addressing mRNA's Scalability And Supply Challenges

10:02 21_10_BPL_mRNAWebinar_1920x1080_Seg04

The Market For mRNA Vaccines & Therapeutics

BIOPROCESS AUTOMATION: TRUTH OR ILLUSION?

1:02:59 21_09_BPL_AutomationWebinar_1920x1080_OD
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.

14:15 21_09_BPL_AutomationWebinar_1920x1080_Seg1

BioProcess Automation: Three Leaders On Where They Stand

4:36 21_09_BPL_AutomationWebinar_1920x1080_Seg2

What Motivates A Process Automation Investment?

6:57 21_09_BPL_AutomationWebinar_1920x1080_Seg3

Who Champions Process Automation, And Who Runs It?

8:46 21_09_BPL_AutomationWebinar_1920x1080_Seg4

Technical Implications, Cost Considerations Of BioProcess Automation

6:04 21_09_BPL_AutomationWebinar_1920x1080_Seg5

The Incremental Approach To BioProcess Automation Adoption

10:18 21_09_BPL_AutomationWebinar_1920x1080_Seg6

BioProcess Automation ROI And Next Steps

UPSTREAM PROCESS INTENSIFICATION: REAL-WORLD RESULTS

1:02:33 21_08_BPL_UPIWebinar_1920x1080
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.

7:23 21_08_BPL_UPIWebinar_1920x1080_Seg01

Why Invest In Process Intensification?

12:43 21_08_BPL_UPIWebinar_1920x1080_Seg02

Supplier Qualification & Cost Of Perfusion Intensification

8:00 21_08_BPL_UPIWebinar_1920x1080_Seg03

Process Intensification: ROI Realities & Implementation Considerations

10:43 21_08_BPL_UPIWebinar_1920x1080_Seg04

Regulatory Considerations For Process Intensification

VACCINE MANUFACTURING & REGULATORY ADVANCES: RIDING COVID'S COATTAILS

59:55 21_04_BPL_VaccineMfg_1920x1080
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
8:33 21_04_BPL_VacineMfg_1920x1080_Clip2

Today's Biggest Vaccine Manufacturing Challenges

11:46 21_04_BPL_VacineMfg_1920x1080_Clip1

Vaccine Platforms & Platform Variables

10:56 21_04_BPL_VacineMfg_1920x1080_Clip4

Will Biopharma Regulators Maintain Their Accelerated Pace?

9:02 21_04_BPL_VacineMfg_1920x1080_Clip3

The Biopharma Regulatory Scene Post-COVID

GENE & RNA THERAPIES: REGULATORY REQUIREMENTS TAKE SHAPE

1:00:53 21_06_BPL_ATMPs_1920x1080
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

19:50 21_06_BPL_ATMPs_1920x1080_Seg1

Forming Up A Regulatory Strategy: When And How To Start

11:39 21_06_BPL_ATMPs_1920x1080_Seg4

Regulating Personalized Therapeutics: Are There Precedents?

4:03 21_06_BPL_ATMPs_1920x1080_Seg3

Accommodating The FDA: Handling Change Management In Your Regulatory Strategy

7:51 21_06_BPL_ATMPs_1920x1080_Seg2

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