Navigating AI Compliance In Life Sciences: FDA Policy Insights For AI Governance

When High-Stakes ADC Decisions Can't Wait for More Material or Better Data

Reducing Particulate-Related Batch Risk In Bioprocessing

A Closer Look At How Single Use Consumables Drive Cost Per Therapy

Residual DNA Testing Across Biotherapeutics

Global Regulatory Compliance For Aseptic Barrier Systems

Building Scalable Non-Viral Gene-Edited Cell Therapy Processes

Automating Cell Therapy Manufacturing Without Redesigning Workflows

Smarter DNA, Healthier Cells

How Intensified Upstream Processing Improves Scale-Up And Tech Transfer

Reducing Particulate-Related Batch Risk In Bioprocessing

How Intensified Upstream Processing Improves Scale-Up And Tech Transfer

Generate Stable High-Producing Clones In 14 Weeks

Using Residual DNA Quantification Data To De-Risk mAb Development

Efficient mAb Development With A Flexible Purification Toolkit

CAR-T Strategy In 2026: Scaling Autologous, Advancing Allogeneic

Maximizing Performance And Quality In Fed-Batch And Perfusion-Based IgG Productions Customer Interview

How MacroGenics Increased mAb Titers By Up To 80% In Scale-Up

Boost CHO Cell Protein Production By Up To 146% With Efficient-Pro™ Feed Solutions

Driven By Performance: Empowering Biotech Innovation From Lab To Life

Defined Media, Defined Results: Scaling E. coli From Bench To Fermenter

DynaDrive S.U.B. Video Series

Digital Design Meets Proven Performance: The Future Of Single-Use Assemblies

DynaDrive Single-Use Bioreactors Drilled-Hole Sparge Technology

DynaDrive Single-Use Bioreactors - One Reactor, Many Volumes

Scale With Confidence From Bench To Commercial Production

Why Is The Bioreactor Square? The Geometry Behind Exceptional Mixing

Aegis Film For DynaDrive Single-Use Bioreactors

Applying AI And Rapid Prototyping To Media And Process Development

Five Reasons To Choose Single-Use Bioreactors

Go Beyond Custom Media Screening And Prototyping

Take The Lead With The Gibco CHOvantage™ GS Cell Line Development Kit

ResDNASEQ Workflow Solution

Achieving Stability For mRNA

Elucidating The Role Of IL-18 In NSCLC Integrated Analysis

An All-In-One Solution For Residual DNA Quantitation

Real-Time Monitoring And Automated Sampling For Enhanced Efficiency

LC/MS Method For Measurement In Human Plasma

Can You Run Crude Samples Using An SPR Instrument?

Electroporation As A Method For Genetic Modification

Base Editing's Advantages When Combined With Non-Viral Delivery Methods

Using ddPCR Technology To Characterize The Poly(A) Tail Content

Why iPSC Is Research Thriving

Ori Spotlight: Building Early-Phase CGT Infrastructure For Translational Success

How Precision Oncology Is Redefining Cancer Drug Development with Aprea Therapeutics' Dr. Oren Gilad

Exploring Dendritic Cell Therapy for Solid Tumors with Diakonos Oncology's Jay Hartenbach

Cell & Gene: The Podcast Presents: Better Biopharma's Editors' Roundtable — A Midyear Look at the 2026 Life Sciences Industry

Why In Vivo Therapies Are Moving Toward the Clinic with Ascidian Therapeutics' Dr. Mike Ehlers

Reimagining In Vivo Gene Editing Through Base Editing and Targeted Delivery with Beam Therapeutics' Gopi Shanker, Ph.D.

Advancing CAR T for Drug-Free Remission in Autoimmune Disease with Kyverna Therapeutics' Dr. Naji Gehchan

The Future of In Vivo Gene Editing and Clinical Translation with Precision Biosciences' Cassie Gorsuch, Ph.D.

Redefining CAR-T Timing and Patient Access with Allogene Therapeutics' Dr. Zachary Roberts

Building Integrated cGMP Systems for Autologous Cell Therapies with MassGen's Tatyana Matveeva, Ph.D.

Rewriting Disease Biology Through LSD1 Inhibition with Oryzon's Carlos Buesa, Ph.D.

Advancing Early Detection in Rare Cancers with Catriona Jamieson, M.D., Ph.D.

Regulatory Flexibility in CGT: Key Shifts and Implications with Monika Swietlicka

How To Choose A Capping Method In MRNA Production

AseptiQuik PPSU

Freezing Studies For Single-Use Solutions: Therapy Containment/Protection (Part 3)

Take The Lead With The Gibco CHOvantage™ GS Cell Line Development Kit

DynaDrive S.U.B. Video Series

Elutriation And Washing In One System

Mycap® CCX Cell Culture Expansion System

Breaking Down Shipping

Inside Bioprocessing: Multi-Omics

A Conceptual Overview Of The BioSMB MCC Platform

Optimizing VLP Manufacturing For Gene Editing By GMP-Compliant Flow Electroporation®

Regulatory And Biosafety Testing Expertise

A Concept-To-Commercial Gene Therapy CDMO

The Power Of Partnerships And The Rise Of iPSC

Early-Phase Whole-Body PK

What Is Causing Limited Bioavailability

Biopharma Resilience: Bionova Scientific Talks Capacity, Speed, And Agility

Closing Ancillary Processes: The New Bottleneck In Cell and Gene Therapy

Selecting The Right CMO For Your Gene Therapy

Breaking Down Shipping

A Dedicated Team To Safely Store Your Cell And Virus Banks

Storing Your Banks With Ease And Confidence

Risk Mitigation Strategies

Comparing Manual Vs. Automated Processing And Thawing Systems

Balancing Innovation With Manufacturability When GMP-Grade Is Unavailable

mRNA For Cancer Immunotherapy 2024 Outlook | Audience Q&A

Overcoming Cryopreservation Challenges

Perfusion: Planning A Run

Supply Chain And Operational Challenges Facing mRNA

An Inside Look At Umoja Biopharma And Bristol Myers Squibb's Cold Chains

Singapore Single-Use Site Capacity Expansion

Enhancing Particle Recovery And Infectivity In Viral Vector Purification

Smart Manufacturing Decisions For Scalable Gene Therapy Success

From Bench To Bioproduction: Scalable MSC Expansion

Cell Handling Across Cell Types

High-Precision Fluid Management For Cell-Based Applications

Enhancing CGT Analytics And Quality Control With Digital PCR

Non-Viral Delivery Of Complex Cargos For Large-Scale CAR-T Manufacturing

Quantifying Potency In Cell & Gene Therapy

Integrated Reagent Solutions For CAR-T/NK Development And Manufacturing

How Raw Materials, Media Composition, and Process Decisions Shape Therapy Development

Fostering Closed-System Innovation For Flexibility And Scalability

Visual Inspection Of Advanced Therapy Medicinal Products

Solving Vector Yield Challenges in In Vivo CGT

How CGT Developers Can Choose the Right Manufacturing Model for Their Pipeline

Distributed Manufacturing for CGT: Rent, Lease, or Buy in an Era of Overcapacity?

Materials Matter: Ensuring Quality Of CGT Materials

Building Smarter Cell Therapies With AI And Synthetic Biology

2026 Regulatory Roadmap

Driving Efficiency, Reducing Costs In Multi-Modal CGT Manufacturing

Viability On The Line: Defining Minimum Quality For CGT Raw Materials

Designing Early Manufacturing For Long-Term Success In CGT

Building The Future Of Cancer Immunotherapy Through Allogeneic NK Cell Innovation

Redefining CGT With Exosomes And EVs

Advancing Gene Delivery: LNPs, Adenovirus, Lentivirus, And More

Unlocking The Potential Of iPSC Therapies In Regenerative Medicine

Emerging Manufacturing Technologies For Cell Therapies

Optimizing Storage Solutions For Allogeneic iPSCs

2025 CGT Regulatory Outlook

Unlocking The Full Potential Of AAV-Mediated Gene Delivery

Inside The Most Promising Non-Viral Approaches For Genetic Engineering

From Bottleneck To Breakthrough: Reimagining The mRNA Therapeutics Supply Chain

Modernizing CAR-T Manufacturing: Is Point Of Care The Future?

Top Strategies To Reduce Off-Target Effects For Safer Genome Editing

Inside Next-Gen Platforms For Cell Therapy Manufacturing

Unlocking The Future Of Allogeneic Cell Therapy For Oncology

Stem-Cell Derived Therapies: From Source To Site

How To Reduce Batch-to-Batch Variation In Cell Therapy Manufacturing

2024 Regulatory Outlook With FDA's Drs. Peter Marks And Nicole Verdun

Considerations For Investing In Your Gene Therapy's Automation Framework

mRNA For Cancer Immunotherapy: 2024 Outlook

Are We There Yet? Roadmap(s) To Higher Quality AAV

Optimizing Your Cold Chain For Cell Therapies

Stability To Scalability: The Future Of Viral Vector Therapies

Regulating The CGT Workflow To Improve Patient Safety

Driving Down COGS: Automation's Role In Cell Therapy Manufacturing

Major Trends In Next-Gen RNA Engineering

Building An In-House Cell & Gene Manufacturing Facility: Best Practices & Lessons Learned

Scaling Cell Therapies Part 2: Establishing Comparability In Manufacturing

Tackling Cell And Gene Therapies' Top 3 Regulatory Impediments

Evaluating Translational Research Tools For CGTs

Scaling Cell Therapies: Auto vs. Allo

Advancements In Targeted mRNA Delivery

Win The CGT Talent Fight: How To Find And Retain Experts

Kite Pharma's Ultimate Supply Chain Test - A Q&A With Their 4-Exec Panel On Overcoming The Pandemic's Disruption

The Therapeutic Potential Of Exosomes

The Future of CRISPR-Engineered Stem Cell Therapies

Regulatory And Biosafety Testing Expertise

Master The 2-Point Calibration Process To Maintain Data Integrity

Key Regulatory Challenges, Innovations, And Opportunities For CGT In 2025

Simplifying Bioprocess Data Collection

Regulatory Challenges And Future Outlook For iPSC Therapies

mRNA For Cancer Immunotherapy 2024 Outlook | Audience Q&A

CGT's Main Opportunities To Meet Regulatory Requirements

Tackling Cell And Gene Therapies' Top 3 Regulatory Impediments: Audience Q&A

Lower Variability For Viral Titer Determination

Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies

A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems

How Past Gene Therapy Approvals Are Shaping the Future with Dr. Peter Marks

Bridging Analytical Gaps To Ensure CGT Material Quality

Cell And Gene Therapy Innovations

Mitigate Clinical Risk In Cell Therapy Development With A GMP Compliant Process

A CDMO Perspective: Bioprocess Automation And Data Management

Making USP Guidance Actionable For CGT Materials

Race To The Regulatory Finish Line: Dr. Nicole Verdun Talks Efficiencies In Platform Technologies

Other CGT Regulatory Challenges

Strategies To Reduce Regulatory Risks In Gene Therapy

CMC Comparability: Transitioning to Commercial Manufacturing with Dr. Nicole Verdun

Challenge #1: The Changing Regulatory Landscape

Congruence And Divergence In Global Regulatory Approvals

Challenge #3: Lack Of Animal Models

Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing

How The FDA's 2024 Draft Guidances Will Influence CGT Regulation In 2025

MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing

2025 CGT Regulatory Outlook | Audience Q&A

How The New Administration Could Shape FDA Oversight, Compliance, And Guidance In 2025

Assessing Residuals In Processing And Fill/Finish For iPSCs

Prioritizing Quality, Fit, And Supplier Reliability In CGT Materials

Patient Data's Impact On CMC Robustness

Future Proof Process Design Through Risk-Focused Decisions, Automation Readiness, And Regulatory Pragmatism

What's New for 2024: Dr. Nicole Verdun Offers a Look Inside The Office Of Therapeutic Products

Why Clinical Requirements Change: Dr. Peter Marks on Pre-IND Meeting Pathways

Navigating Global Regulations, Equity Challenges, And The Future Of Patient Access

Inside The Phased, Risk-Based Approach For CGT Materials

How The FDA Strengthens Industry Collaboration

Executive Roundtable: Cell Therapy Predictions For 2025 And Beyond

Ensuring Consistent Removal Of Residual Impurities

Challenge #2: Rare Or Ultra-Rare Study Design Considerations And Use Of Existing Data

Late-Stage Development And Commercial Planning With CervoMed's Matt Winton, Ph.D.

BoB@BIO: Biotech In The Balance With Ovid Therapeutics' Dr. Jeremy Levin

BoB@BIO: Biotech Investing And Deals With Sofinnova's Maha Radhakrishnan, M.D.

Targeting Tau in Alzheimer's Disease With Voyager Therapeutics' Al Sandrock, M.D., Ph.D.

Keeping An Early-Stage Cell Therapy Biotech In The Black With IN8bio's William Ho

Drug Launch Success In A Changing Commercial Landscape With ACMA's William Soliman, Ph.D.

The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry

Derisking CNS Drug Development With Tortugas Neuroscience's Jeff Jonas, M.D.

Rare Disease Drug Commercialization With Zevra Therapeutics' Neil McFarlane

Scaling Manufacturing For Personalized Cell Therapies With Cellino's Marinna Madrid, Ph.D.

Building A New Antibody Discovery Platform With Infinimmune's Wyatt McDonnell, Ph.D.

From Partnered ASO Therapies To A Wholly-Owned Pipeline With Ionis's Brett Monia, Ph.D.

Modulating Multispecific Manufacturability With AP Biosciences' JJ You, Ph.D.

The Facility Master Planning Playbook With Herman Bozenhardt

Cell Therapy Without The Cells: Building A Therapeutic Secretome With Noveome Biotherapeutics' Larry Brown, Sc.D.

The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry

Validation Challenges Facing Advanced Single-Use Technologies

Aligning Upstream And Downstream Development (Part 2)

Aligning Upstream And Downstream Development (Part 1)

Reprogramming T Cells And Reducing Manufacturing Costs With RegCell's Michael McCullar, Ph.D.

Scaling Regenerative Medicine Production With PolarityBio's Nikolai Sopko, MD, Ph.D.

Pursuing Quality While Maintaining Process Control With Richard Moroney, Ph.D.

Unlocking The Therapeutic Power Of Fibroblasts With Pete O'Heeron And Hamid Khoja, Ph.D.

Supporting The Bioprocessing Workforce In The AI Era With Sanofi's Eric Doerr