Upstream Processing Featured Articles
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How Computational Drug Discovery Is Disrupting Biopharma
3/12/2021
NeuBase Therapeutics CEO Dr. Dietrich Stephan discusses the important role computational drug discovery plays as we emerge from what he characterizes as “a decades-long, multi-billion-dollar chemical engineering escapade with a very low success rate to find one drug.”
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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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$2,000-Per-Dose Cell Therapy In The Clinic
2/12/2021
With its ongoing Phase 1 clinical trial of ACE1702 for the treatment of HER2-expressing solid tumors, Acepodia founder, CEO, and president, Sonny Hsiao, Ph.D. and SVP of R&D, Mark Gilbert, M.D., make a case for fast, affordable, and effective off-the-shelf cell therapies.
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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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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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Abcentra Chief Looks Beyond The Clinical Horizon
9/26/2019
Why Bert Liang, M.D., Ph.D. obsesses over at-scale manufacturing and regulatory challenges from the outset of clinical trials.
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How Can You Mitigate The Risks Of Single-Use Bags?
8/24/2015
The loss of product as a result of bag failure isn’t just an annoyance; it’s an expense, and a costly one at that. However, Chuck Hart, director of manufacturing at Prolong Pharmaceuticals, says with proper fitting and handling, these concerns can be mitigated.
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Making The Switch To Single-Use: Have You Thought Of Everything?
8/19/2015
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
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Are Your Single-Use Sensor Tests Set Up To Fail?
7/9/2015
When it comes to testing methods, experts warn that the same testing methods used on stainless-steel sensors should not be used for single-use sensors. If an attempt is being made to recreate results achieved with a traditional sensor, it’s very possible for those results to appear unfavorable with a single-use sensor.
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Standardized Extractables Testing Advances Single Use Adoption
6/3/2015
The Standardized Extractables Testing Protocol For Single-Use Systems In Biomanufacturing written by BPOG members last year establishes a foundation from which to create a standardized approach to extractables testing. However, since its release, there have been some questions and discussions about how to effectively implement the protocol.