All Episodes
Off Script: A Pharma Manufacturing Podcast — 142 episodes
Adapting Biologics Manufacturing to a More Complex Market
What Will It Take to Reshore Generic Drug Manufacturing?
How AI-Based Bioreactors Can Improve Enzyme Production
Blow-Fill-Seal and the Future of Sterile Ophthalmic Manufacturing
Can Radiopharma Manufacturing Keep Pace with Demand?
AI’s Impact on Quality Management in Pharma Manufacturing
Single-Use Technologies and the Future of Flexible Biomanufacturing
Solutions Spotlight: Rethinking Filtration as a System-Level Design Decision
How Genomic Language Models Could Accelerate Biomanufacturing
The FDA's PreCheck Program and the Future of Cell Therapy Manufacturing
Solutions Spotlight: Improving Sustainability Through Smarter Steam System Monitoring
How the Framework of Modern Pharma Manufacturing Is Being Rebuilt: Part Two
How the Framework of Modern Pharma Manufacturing Is Being Rebuilt: Part One
Accelerating Biopharma Manufacturing Through Integrated Automation
The Future of Global Biopharma Manufacturing Networks
Building Flexibility into Biopharma Manufacturing
How Biocatalysis Is Changing Pharma Manufacturing
How Peptide Development Complexity Is Reshaping CDMO Partnerships: Part Two
How Peptide Development Complexity Is Reshaping CDMO Partnerships: Part One
Solutions Spotlight: Managing Chloramines in Pharmaceutical Water Systems
Can CDMO-to-CDMO Collaboration Simplify Drug Development?
Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part Two
Delivering Pharma’s Mega-Projects in a Resource-Constrained World: Part One
Annex 1 and the Shift to Proactive Sterile Manufacturing
How U.S. Policy Is Reshaping Pharma Outsourcing
Building the Foundation for Autonomous Bioprocessing
Reshoring APIs and Scaling Continuous Manufacturing for Generic Drug Supply
Engineering the Next Generation of ADCs
Automating Cell and Gene Therapy Manufacturing for Scale
Bridging Precision and Scale in Microparticle Drug Delivery Manufacturing
Fixing the Structural Weaknesses in the Global Drug Supply Chain: Part Two
Fixing the Structural Weaknesses in the Global Drug Supply Chain: Part One
Connected Packaging and the Future of Pharma Manufacturing
Why Cell Line Development Determines Biologics Success
Designing CGT Manufacturing for Scale, Speed, and Access
Robotics and Automation in Pharma Manufacturing
Manufacturing Agility in a Changing Biopharma Landscape
Understanding Pharma Manufacturing’s Domestic Investment Surge: Part Two
Understanding Pharma Manufacturing’s Domestic Investment Surge: Part One
AI and the Future of Drug Development
Predictive Maintenance for a Modern Cold Chain
Building a Future for Curative Cell Therapies: Part Two
Building a Future for Curative Cell Therapies: Part One
Modular Flow Chemistry and the Future of Continuous Manufacturing
The Economics Behind U.S. Generic Drug Manufacturing: Part Two
The Economics Behind U.S. Generic Drug Manufacturing: Part One
CGT Manufacturing Challenges and Opportunities
The State of CDMO Funding: 2025 in Review (Part Two)
The State of CDMO Funding: 2025 in Review (Part One)
Corporate compliance involves more than just cGMP and quality
Charting Pharma Manufacturing Trends: Part Two
Charting Pharma Manufacturing Trends: Part One
Editor’s (re)View: It matters if Big Pharma is fudging its US investment numbers
Can CDMOs keep up with the increasing demand for GLP-1 medications?
FDA’s program to speed up US manufacturing buildouts is short on detail
New Jersey remains hot life sciences hub despite macroeconomic, funding headwinds
Critical Timing: Hikma’s Billion-Dollar U.S. Investment
Editor’s (re)View: Is the biopharma industry’s glass half empty or half full?
Life sciences manufacturers overwhelmingly embrace smart tech: global survey
Flow state: The evolving shape of continuous manufacturing
[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation
Editor’s (re)View: BMS, Merck, Roche see manufacturing flexibility as key to dealing with tariffs
Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs [The good, the bad, the ugly]
Novartis to invest $23B in US sites, US urged to invest $15B in biotech counter to China, Trump warns of major pharma tariffs [The good, the bad, the ugly]
Cellares, Cabaletta validate automated CAR T production, FDA warns Aspen over sterility issues, rejects Hengrui, Elevar cancer combo again [The good, the bad, the ugly]
Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly]
Eli Lilly expands manufacturing to boost supply, FDA blocks imports from two Indian API makers, ICU Medical recalls potassium chloride injection bags over labeling error [The good, the bad, the ugly]
Novartis boosts Slovenia investment to $3.6B, Trump tariffs could unsettle biopharma FDI, FDA warns Global Calcium, blocks US imports [The good, the bad, the ugly]
FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly]
EU approves Novo-Catalent acquisition, CDMO National Resilience announces layoffs, FDA investigates blood cancer reports in gene therapy patients [The good, the bad, the ugly]
FDA approves Imkeldi oral solution, Alector axes workforce, Novartis announcnes layoffs [The good, the bad, the ugly]
FDA grants Regenxbio accelerated path for Duchenne, Neurogene reports death in Rett trial, Halozyme drops Evotec bid [The good, the bad, the ugly]
PTC secures FDA nod, Kronos Bio halts CDK9 development, Marinus slashes 45% of workforce amid setbacks [The good, the bad, the ugly]
Ascendis, Novo ink partnership, Court blocks Sun Pharma launch, FDA moves to delist phenylephrine [The good, the bad, the ugly]
MilliporeSigma expands ADC manufacturing, EU fines Teva, AZ exec under investigation in China [The good, the bad, the ugly]
[Extended Release] Antibiotic resistance crisis and the global efforts against superbugs
Nucleus RadioPharma expands production with new sites, FDA issues CRL to Camurus' hormone disorder drug, NHS rejects Eli Lilly's Alzheimer's drug over cost [The good, the bad, the ugly]
FDA approves AbbVie 24-hour Parkinson’s treatment, Sage Therapeutics axes workforce, FDA halts Novavax's COVID-flu vax trials [The good, the bad, the ugly]
Roche gets FDA nod for breast cancer combo, Kezar’s lupus drug trial on hold, Zealand Pharma’s hypoglycemia drug rejected over manufacturing [The good, the bad, the ugly]
Gilead inks deal with generics manufacturers to expand HIV drug access, J&J announces layoffs, Amgen sued for hiding $10.7B tax bill [The good, the bad, the ugly]
FDA approves BMS schizophrenia drug, bluebird bio announces layoffs, J&J talc subsidiary files for bankruptcy [The good, the bad, the ugly]
[Extended Release] Schizophrenia treatment barriers, KarXT, and the future of neuroscience
Novo Nordisk shares phase 2a obesity trial data, Achilles Therapeutics ends TIL-based therapy, Express Scripts sues FTC [The good, the bad, the ugly]
[Solutions Spotlight] Optimizing contamination control in pharma facilities
Roche wins FDA approval for subcutaneous cancer immunotherapy, Moderna to cut $1.1B in R&D expenses, Teva settles $80M opioid case with Baltimore [The good, the bad, the ugly]
Pfizer, Valneva share phase 2 Lyme vax data, IN8bio axes workforce, AstraZeneca employees detained in China [The good, the bad, the ugly]
FDA approves Illumina cancer biomarker test, BioMarin reveals more layoffs, FDA hits API maker Global Calcium with 483 [The good, the bad, the ugly]
Pharma’s new age of longevity
Emergent donates 50k doses of mpox vaccine to Africa, FDA rejects Regeneron blood cancer bispecific antibody, China indicts Astellas exec for espionage [The good, the bad, the ugly]
FDA approves Ascendis drug, Lykos PTSD treatment rejected, Novartis bid blocked [The good, the bad, the ugly]
Amneal's Parkinson's pill approved, Novo Nordisk withdraws Wegovy approval expansion bid, FDA delays BeiGene Tevimbra decision [The good, the bad, the ugly]
FDA approves Adaptimmune therapy, halts vTv diabetes program; Sanofi sues Sarepta over Duchenne patents [The good, the bad, the ugly]
FDA approves Sun Pharma hair loss drug, FDA issues warning letter to Brassica, EMA rejects Eisai-Biogen Alzheimer's drug [The good, the bad, the ugly]
Genentech's oral weight loss drug shows promise; FDA denies accelerated approval for Agenus' cancer drug; Orexo's opioid overdose drug rejected again [The good, the bad, the ugly]
Pfizer advances obesity pill, FDA rejects Novo insulin, FTC releases PBM report [The good, the bad, the ugly]
Lilly Alzheimer’s drug gets full approval, Rocket gene therapy rejected, Eisai, BMS end ADC partnership [The good, the bad, the ugly]
[Solutions Spotlight] Streamlining oral dose packaging design
Verona wins COPD nod, FDA rejects Merck-Daiichi ADC, Glenmark recalls potassium chloride capsules [The good, the bad, the ugly]
Gilead HIV shot delivers zero infections, Takeda epilepsy drug misses endpoints, Lilly goes after counterfeiters [The good, the bad, the ugly]
FDA backs Lilly Alzheimer’s drug; Pfizer Duchenne gene therapy fails; Talc plaintiffs seek J&J bankruptcy restraining order [The good, the bad, the ugly]
AZ's Tagrisso shines in phase 3 trial, BMS layoffs, FDA violations at Jiangsu Hengrui site [The good, the bad, the ugly]
J&J depression drug aces trial, Takeda plans layoffs, FDA delays review of Sanofi-Regeneron's Dupixent [The good, the bad, the ugly]
Mining pharma's reshoring rush
FDA approves biosim to Regeneron Eylea, Evotec exits gene therapy, J&J reports deaths in radioligand trial [The good, the bad, the ugly]
FDA approves Amgen's T-cell engager for lung cancer, BioMarin announces layoffs, FDA delays Ascendis drug review [The good, the bad, the ugly]
Vertex submits NDA for CF drug, MacroGenics reports ADC prostate cancer trial patient deaths, FTC extends review of Novo-Catalent deal [The good, the bad, the ugly]
Neurocrine wins FDA nod for 'sprinkle' Ingrezza, Moderna-Metagenomi deal ends, Emergent's layoffs [The good, the bad, the ugly]
Novartis wins rare cancer pediatric indication, BMS layoffs, McKinsey under fire [The good, the bad, the ugly]
GSK antibiotic hits phase 3 goals, Genentech-Adaptimmune collab ends, Par Pharma recall [The good, the bad, the ugly]
BMS schizophrenia drug shines, Novartis axes jobs, Lilly compounding suit dismissed [The good, the bad, the ugly]
2024 election's impact on manufacturing
Basilea grabs FDA nod, Verve halts gene editing trial, Amylyx pulls ALS drug [The good, the bad, the ugly]
[The good, the bad, the ugly] Editor's Review week of March 25
[The good, the bad, the ugly] Editor's Review week of March 18
[The good, the bad, the ugly] Editor's Review week of March 11
[The good, the bad, the ugly] Editor's Review week of March 4
[The good, the bad, the ugly] Editor's Review week of February 29
[The good, the bad, the ugly] Editor's Review week of February 23
Raising a modern CDMO
[Solutions Spotlight] Meeting today’s container closure integrity requirements
[Solutions Spotlight] Ensuring quality during a syringe surge
[Solutions Spotlight] Overcoming drug formulation challenges
[Solutions Spotlight] Bringing pharma’s asset management into the digital age
[Solutions Spotlight] How to overcome challenges in ophthalmic formulations
[Solutions Spotlight] How digitalization can provide a competitive advantage
[Solutions Spotlight] Stop the stall: The time is now for predictive maintenance in pharma
[Solutions Spotlight] A groundbreaking approach to BET testing
[Solutions spotlight] A better way to measure critical attributes in bioreactors
[Solutions Spotlight] Special delivery: Lipid nanoparticles usher in new treatments
[Solutions Spotlight] Harnessing AI to improve workplace ergonomics
Is it time to call the dogs off drug testing?
Drugs down the drain
[Solutions Spotlight] Elevating quality inspection with AI
Inside the FDA’s fateful Alzheimer’s decision
Growing the biologic drug supply
Will the FDA keep moving at this breakneck pace?
Pharma's wild ride through 2020
Saving the shrinking pipeline for antibiotics
Reaching undecided vaxxers: Can pharma simultaneously advance vaccines and public trust
[Solutions Spotlight] Pharma’s drive towards more sustainable packaging
Pharma's next big hurdle — distributing vaccines
The United States of Generics