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The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more!
Episodes

Jun 23, 2025
![[Solutions Spotlight] Hydrogenation: Bridging the gap between nitration and phosgenation](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
May 12, 2025
May 12, 2025
18 min
Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes.
To better understand this connection, we spoke with Dr. Luca Mantilli, R&D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardous chemistries: nitration and phosgenation.
Learn more about Valsynthese: https://www.valsynthese.ch/

Apr 30, 2025
Apr 30, 2025
4 min
The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.
![Thermo Fisher opens cell therapy center, FDA cites Aurobindo site, Trump probes pharma imports ahead of tariffs [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Apr 21, 2025
Apr 21, 2025
4 min
The good — Thermo Fisher opens center to boost cell therapy development
The bad — FDA cites Aurobindo plant after Raleigh inspection
The ugly — Trump probes pharma imports as tariff threat looms
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Apr 14, 2025
Apr 14, 2025
4 min
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Novartis to invest $23B in U.S. manufacturing and R&D, including seven new sites
The bad — U.S. urged to invest $15B to counter China’s biotech rise
The ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Mar 26, 2025
Mar 26, 2025
3 min
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Cellares, Cabaletta validate automated CAR T production
The bad — FDA warns Aspen over sterility issues
The ugly — FDA rejects Hengrui, Elevar cancer combo again
![Axplora expands ADC capacity, Merck KGaA CDMO business slump, FDA issues a warning letter to Granules India [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Mar 17, 2025
Mar 17, 2025
3 min
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand.
The bad — Merck KGaA’s CDMO business reports a decline
The ugly — The FDA issues a warning letter to Granules India over manufacturing violations
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Feb 25, 2025
Feb 25, 2025
3 min
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Eli Lilly expands manufacturing to boost supply
The bad — FDA blocks imports from two Indian API makers over manufacturing violations
The ugly — ICU Medical recalls potassium chloride injection bags over labeling error
![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]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Feb 18, 2025
Feb 18, 2025
4 min
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Novartis boosts Slovenia investment to $3.6B
The bad — Trump tariffs unsettle biopharma FDI
The ugly — FDA warns Global Calcium, blocks US imports
![FDA approves Opdivo subcutaneous version, Marinus Pharmaceuticals sells operations, Novo Nordisk pushes back against compounding pharmacies [The good, the bad, the ugly]](https://pbcdn1.podbean.com/imglogo/image-logo/9655061/Security_14__hjvhxj_300x300.jpg)
Jan 7, 2025
Jan 7, 2025
3 min
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Opdivo subcutaneous version
The bad — Marinus Pharmaceuticals sells operations
The ugly — Novo Nordisk pushes back against compounding pharmacies
