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 — Amtagvi approval The bad — Rapt clinical hold The ugly — Novavax and Gavi settlement
Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forging the future of pharma. During this podcast, Chief Content Director Karen Langhauser will introduce you to the four promising CDMOs we’ve chosen to ...
In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Derek Duncan Product Line Director, at Lighthouse Instruments to discuss the significance of CCI and the evolving landscape of CCI testing, regulatory guidance, and the unique considerations posed by innovative therapies with extreme storage and transport requirements. Read the transcript: https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight Learn more about Lighthouse instru...
In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection solutions can help. Read the transcript: https://pharmamanufacturing.com/33009598 Learn more about Stevanato Group: https://www.stevanatogroup.com/en...
In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Daniel Price, director and head of excipients, solid applications at MilliporeSigma , to discuss his work driving innovation in the fields of 3d printing of oral solid dosage forms, next generation pharmaceutical manufacturing, oral delivery of novel modalities and predictive formulation, and how these innovations can help overcome today's drug formulation challenges. Read the transcript: https://pha...
For those in the pharmaceutical industry, the recent challenge has been in figuring out how to extend the digital capability of our everyday lives into pharma asset management. How do you bring all of a plant's activities and the data behind them into one place? Furthermore, if you could do that, what benefits would it bring to asset management? Karen Langhauser is joined by Ethan Smith, general manager of Life Sciences for Nuvolo, to get a better understanding of how pharma can bring its asset ...
Ophthalmic drug formulation and manufacturing brings with it unique challenges and regulatory requirements. To discuss methods to overcome these challenges, Pharma Manufacturing Senior Editor Andrea Corona speaks with Smita Rajput, field marketing manager at MilliporeSigma. Learn more about MilliporeSigma: https://www.emdmillipore.com/US/en Read the transcript: https://pharmamanufacturing.com/21436478...
The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and Fabio Bertacchini from Stevanato Group. Learn more about Stevanato Group: https://www.stevanatogroup.com/en/ Read the transcript: https://www.pharmamanufacturing.com/pod...
Predictive maintenance can help pharma companies can capture enormous value. Digital solutions can help eliminate downtime, reduce maintenance costs and maximize productivity, ultimately unlocking the capacity that is necessary to get the highest quality product to patients who need them most. Senior editor Andrea Corona discusses this with Zach Gilulah, pharma machine health lead at Augury Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcas...
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.co...
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...
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 w...
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 Mc...
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
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...
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/ Re...
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...
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....
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.
Pharma stepped up to the plate this year to deliver vaccines in record time and desperately needed therapeutics. Will these historic achievements change the industry's reputation in the eyes of the public? Chief Content Director, Karen Langhauser, and Senior Editor, Meagan Parrish, take a look back at pharma's accomplishments — and stumbles — during the pandemic. Read the transcript . Audio clips used: CNBC: "How pharmaceutical companies are responding to the coronavirus outbreak" CNA: "Pharmace...
The threat of superbugs hasn’t gone away and in many ways the pandemic has made this problem loom even larger. But a new organization called the AMR Action Fund is working to infuse needed dollars and resources into the dwindling pipeline for needed antibiotics. Read the full transcript
As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss. Read the transcript here: https://bit.ly/34PEeb6
Chief Content Director Karen Langhauser is joined by Richard Wood, Executive Director of Technical Solutions at Softbox Systems. Read the full transcript: https://bit.ly/2JaQOsQ Learn more: https://bit.ly/2G8oWo3
It's been called the biggest logistical challenge of all time. What does pharma and the government need to do to quickly and successfully deliver COVID-19 vaccines into the waiting arms of Americans? Senior editor, Meagan Parrish, chats with PwC's Omar Chane to find out. Read the full transcript here: https://bit.ly/3dJdhZs
Should America reshore more generic drug manufacturing? Will it really keep our supply chains safe from disruptions? For our September cover story, we took a deep dive into these questions to untangle the arguments around reshoring generic drug production. Find out why we walked away so obsessed with Rosemary Gibson and why Phlow Corp. might be the company that settles the debate around reshoring once and for all.
