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Dec 12, 2024 | 
bioprocessintl.com | Cheryl Scott |Dana Cipriano |Brian Gazaille |Derek Ryan
Potency. Stability. Product characterization. Bioassays and other analytical methods provide a foundation of information on which biopharmaceutical development and manufacturing are built. Companies working with proteins, gene therapies, and other biological modalities are increasingly interested in taking a platform approach. They would love to have a set of go-to methods and protocols that can be applied across similar products in their portfolios.
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Nov 22, 2024 | 
bioprocessintl.com | Xiaojun Liu |Brian Gazaille |Allan Bream |Tereza Pavlištová
Gene therapies are emerging as promising treatments for previously untreatable genetic disorders, with adeno-associated viruses (AAVs) being the preferred vector for gene delivery. However, AAV-based gene therapies face challenges in production, including cost, complexity, and scalability. With the gene therapy market projected to grow significantly, drug developers are seeking platforms that streamline AAV production.
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Oct 17, 2024 | 
bioprocessintl.com | Brian Gazaille |Allan Bream |Brita Hobmann
Guided by standardized production and purification platforms, developers of monoclonal antibodies (mAbs) and other recombinant-protein therapeutics can take a relatively straightforward path when designing and establishing facilities for commercial-scale operations. By contrast, designing gene-therapy (GT) facilities involves a more complex calculus. Multiple approaches are available for producing transgene-bearing viral vectors at commercial scales.
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Sep 1, 2024 | 
bioprocessintl.com | Cheryl Scott |Gigi Bat-Erdene |Jeff Fischer |Brian Gazaille
With the first half of 2024 now in the rearview mirror, I finally feel like I’m getting my feet under me as editor in chief ofBioProcess International. Since the first issue in January 2003, I’ve had the pleasure of helping BPI to establish itself as the leading publication and events brand for the global biopharmaceutical industry. And this September, all the BPI editors will attend our flagship conference and exhibition as part of the Biotech Week Boston festival.
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Jul 31, 2024 | 
bioprocessintl.com | Brian Gazaille
Although expression titers have increased significantly since the 1990s, biopharmaceutical scientists still have much to learn about engineering cell lines for biologics manufacturing, especially as therapeutic proteins grow in diversity and complexity. At the BPI Theater during the 2024 BIO International Convention, BioProcess Insider editor Millie Nelson moderated a panel discussion about strategies for improving cell-line development (CLD).
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Jul 26, 2024 | 
bioprocessintl.com | Derrick Zhang |Shankar Sellappan |Brian Gazaille |Eric Bishop
Host cell proteins (HCPs) have become particularly notorious among process-related impurities. Purification workflows generally yield highly pure drug substances, and the biopharmaceutical industry has a strong track record of ensuring patient safety. However, some HCPs are known to coelute with therapeutic proteins into drug substances.
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Jun 26, 2024 | 
bioprocessintl.com | Cheryl Scott |Vincenza Pironti |Brian Gazaille |Kurt D. Ristroph
Advances related to drug delivery, formulation, and fill–finish have paralleled drug-modality research in recent years. Perhaps inevitably, the newest formulations and devices bring forth a number of technical and operating challenges in areas such as contamination control, standardization (especially for prefilled syringes), lyophilization, serialization, and management of outsourcing/partnering relationships.
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May 31, 2024 | 
bioprocessintl.com | Diane McCarthy |Brian Gazaille |Tim Moore |Mark W. Frohlich
Allogeneic cell therapy has become an entrenched concept in the biopharmaceutical industry. Despite clear successes for autologous therapies, especially those based on chimeric antigen receptor (CAR) T cells, cell-therapy companies have yet to devise scalable means for making drug products based on cellular material from and for individual patients. Thus, many cancer patients are left without access to potentially life-saving treatment.
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May 31, 2024 | 
bioprocessintl.com | Diane McCarthy |Brian Gazaille |Mark W. Frohlich |Tim Moore
Allogeneic cell therapy has become an entrenched concept in the biopharmaceutical industry. Despite clear successes for autologous therapies, especially those based on chimeric antigen receptor (CAR) T cells, cell-therapy companies have yet to devise scalable means for making drug products based on cellular material from and for individual patients. Thus, many cancer patients are left without access to potentially life-saving treatment.
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May 10, 2024 | 
bioprocessintl.com | Shuai Wang |Dujuan Lian |Brian Gazaille |Cheryl Scott
Jun 17 - Jun 20, 2024Our Biopharmaceutical School is the perfect course to gain a well-rounded understanding of the Biopharmaceutical industry. Over three days, you will understand the principle steps in the biopharmaceutical lifecycle, including: raw material selection, up and downstream processes and core technology. Additionally, you will be familiarised with the latest industry trends, including Industry 4.0, and how these are likely to impact the industry’s evolution.
