[Solutions Spotlight] A groundbreaking approach to BET testing

Endotoxin testing serves a vital function in pharma quality control by ensuring that products are safe for patients. But the traditional approach to Bacterial Endotoxins Testing (BET) is an area ripe for disruption and improvements. Now, the Sievers Eclipse BET platform by Suez offers new levels of automation, compliance and sustainability, ushering in the next generation of BET.

Learn more about Suez: https://www.suezwatertechnologies.com/ 

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing

Solutions spotlight: A better way to measure critical attributes in bioreactors

In pharma, the use of gas analysis in fermentation bioreactors is critical for monitoring the health of a culture, and measuring small changes to oxygen and carbon dioxide concentrations at key phases of the process. Whether using continuous or batch fermentation for bacterial, microbial or mammalian cell culture expression, Thermo Fischer Scientific's gas analysis mass spectrometry product range provides precise off-gas analysis through every stage of fermentation. To learn more about the Prima BT and Prima PRO models, senior editor Meagan Parrish chats with Daniel Merriman, strategic marketing manager, Thermo Fischer.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process

[Solutions spotlight] Special delivery: Lipid nanoparticles usher in new treatments

RNA-based vaccines have played a starring role in the ongoing COVID-19 pandemic and there is great potential for RNA to be applied to further indications. But nucleic acids are highly negatively charged and fragile and the right delivery systems are needed to protect RNA from degradation. One technology — lipid nanoparticles — has proven to enable the drug delivery of RNA-based therapeutics. Karen Langhauser and MilliporeSigma’s Dr. Estelle Beguin discuss lipid nanoparticles and the role they will play in the success of emerging therapies and vaccines.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments 

Solutions Spotlight: Harnessing AI to improve workplace ergonomics

Poor ergonomics have been linked to a host of physical problems and can have an impact on workplace efficiency. Improving posture and physical habits has been linked to increased worker productivity and reduced errors. A reduction in injuries also saves money for companies, and helps businesses retain healthier and happier employees. However, many companies might overlook this aspect of workplace safety and this is where artificial intelligence can come to the rescue. Meagan Parrish and Blake McGowan, Director of Ergonomics Research for VelocityEHS, discuss.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics 

Is it time to call the dogs off drug testing?

Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development.

Learn more about the White Coast Waste Project: https://www.whitecoatwaste.org/

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/is-it-time-to-call-the-dogs-off-drug-testing

Drugs down the drain

When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look at this issue and considering new policies aimed at reducing this kind of medical waste.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain 

Solution Spotlight: Elevating quality inspection with AI

The importance of quality in pharma manufacturing can't be overstated. Fortunately, the industry has stepped up drug quality. While much of this can be attributed to better science and clearer guidance, technology improvements — like the application of AI to visual inspection equipment — have potential. Chief content director Karen Langhauser and Giacomo Girotto, vision inspection project manager for Stevanato Group discuss.

Learn more about Stevanato Group: https://www.stevanatogroup.com/en/

Read the full transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai 

Inside the FDA’s fateful Alzheimer’s decision

If Biogen’s controversial aducanumab is approved, it could become the best-selling drug of all time — and it’s a drug that has only shown modest efficacy. Here’s more on why the Alzheimer’s pipeline is primed for such a remarkable situation.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision 

Growing the biologic drug supply

The complex development and manufacturing processes needed to bring biologic drugs to market almost always translates into exorbitant prices, even after the drugs go off patent. Consequently, many areas of the world simply do not have access to the accepted standard of care. Chief content director Karen Langhauser sat down with the founders of Phylloceuticals to discuss how they plan to change this.

Learn more about Phylloceuticals at http://phylloceuticals.com.

Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/

Will the FDA keep moving at this breakneck pace?

What has allowed the government to — for once — move at the speed of industry to help curb the pandemic? And will the FDA be able to maintain this pace once the pandemic winds down?

We caught up a long-time regulatory expert to find out.

Read the transcript.