GMPs Featured Articles
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Dr. Bobby Gaspar On Manufacturing, Commercialization Challenges
2/22/2021
Orchard Therapeutics CEO Dr. Bobby Gaspar, M.D., Ph.D. is one of only a handful of gene therapy leaders to see the light of market-approved therapy. Here, he offers advice for those seeing manufacturing, regulatory, and reimbursement challenges for the first time.
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Beating Stem Cell Sourcing, Exosome Production Challenges
1/29/2021
Urgent medical needs like COVID-19 therapeutics are fueling new interest in cell-based therapies, despite a years-long, uphill social battle. Here’s how one company’s persistent, global pursuit of safely harvested biologics is positioning it to address the greatest medical need of our time.
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Is Your Definition Of Quality Culture The Same As The FDA's?
1/19/2021
Steven Niedelman and Christina Markus boast more than 70 collective years of pharmaceutical regulatory experience, which will be on full display when they tell you where your quality culture may be falling short at the upcoming FDA/Xavier PharmaLink conference in March. Here’s a sneak peek.
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New Podcast: Building Blocks Of The Biopharma Business
4/21/2020
We just launched the first full episode of the Business of Biotech podcast, a series purpose-built for the leaders of new and emerging biopharma companies. Here’s a recap of the first episode with industry icon Allan Shaw, highlighting the season to come and offering some strategic, straightforward advice for new biopharma leaders.
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Introducing The Business Of Biotech Podcast
4/17/2020
BioProcess Online is proud to launch The Business Of Biotech, a podcast series dedicated to the leaders of new and emerging biopharma firms as a resource on their journey from drug discovery to success in the clinic. Here's a preview of our first season, stacked with insight from founders who have done just that.
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Inside FDA’s AI-Based Established Conditions Pilot
4/1/2020
FDA-CDER’s Geok Yan Loo gave us an inside look at CDER’s application of artificial intelligence to inform and improve pharmaceutical quality systems. The pilot offers good reason to consider how machine learning can improve bioprocessing quality and ease your regulatory burden.
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Alternative Funding For Startup Biotechs
12/13/2019
Tough competition for traditional funding has led creative biotech entrepreneurs to seek alternative and diversified sources. Chad Dehmer, senior manager of business development at UPMC Enterprises, walks us through one such alternative.
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Quality Risk Management: Reduce Risk By Embracing It
5/26/2015
Despite the resources available to help companies develop a QRM program, such as the ICH Q9, there are several challenges that commonly prevent a successful implementation. Ghada Haddad, director in global sterile and validation at Merck, suggests several best practices that can help overcome these issues.
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Quality Takes Center Stage At ISPE Event
5/20/2015
As the pharmaceutical landscape continues to change and evolve, it is up to you to not only determine how to raise the bar for innovation but also do so with the utmost focus on quality. If you take a look at the ISPE/FDA/PQRI Quality Manufacturing Conference agenda, attendees will see this is an opportunity to learn how to accomplish just that.
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How Reliable Is The Pharma Equipment You Buy?
8/13/2013
When it comes to equipment manufacturing in the pharmaceutical industry, it is imperative that a product functions exactly as it was intended. Any misstep caused by faulty equipment could have catastrophic results for the company that produces a drug, but more importantly, for the patient who uses it. The serious consequences that can result from a lack of accurate equipment design and the associated manufacturing processes are why Donald Dobert, president and COO of ATL Pharmaceutical/Medical, created his company’s New Product Development (NPD) Planning Process.