BioProcess International Magazine

BioProcess International™ is a monthly magazine with a targeted circulation focused on the creation, scaling, and production of biotherapeutics and biodiagnostics. Every edition delivers the latest, peer-reviewed insights to the global biotherapeutic industry, covering essential topics such as business strategies, political issues, ethical considerations, applications, products, and services necessary for effectively advancing biopharmaceuticals, vaccines, and biodiagnostics from development to manufacturing.

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Viral vector manufacturing capacity outpaces demand through 2031, modeling shows

2 days ago | bioprocessintl.com | Cheryl Scott

Rapid advancement of gene therapy has driven a surge in demand for clinical-grade viral vectors. Can the industry meet that demand with manufacturing capacity? The short answer is “Yes – and then some!”As part of the cell and gene therapy track on day three of BPI Europe – held in Hamburg, Germany, this past May – Andrew Harmon of Latham BioPharm Group (part of Sia Partners) presented an approach for modeling biopharmaceutical market demand.
Mass Photometry for AAV Upstream Process Monitoring

1 week ago | bioprocessintl.com | María Victoria

Adenoassociated viruses (AAVs) are versatile tools for reliable, efficient delivery of genetic material to host cells. Approved for use in several products, AAVs are among the most frequently used gene-therapy vectors, supporting treatment of many genetic conditions. But AAV production is a complex, multistage process that requires robust process monitoring.
Maria Jacintha Victoria

2 weeks ago | bioprocessintl.com | María Victoria

WuXi Biologics announces Virogen and VISEN projects at new Chengdu facility
Extending Bioproduction Capacity's Global Reach

1 month ago | bioprocessintl.com | James Choi |Josh Abbott |Shreeyashi Ojha |Dan Stanton

Planning for commercial biologic manufacturing is challenging, not least because it requires considerable time, investment, and economic risk. As global demand for biopharmaceuticals climbs, drug companies will need to be resourceful to ensure that their products will be manufactured at sufficient volumes and in the desired markets. This eBook places bioproduction capacity in the spotlight, highlighting options that biologics developers can leverage as they seek to expand their global reach.
CDMO Piramal Pharma bolsters US footprint with $90m facility expansion

1 month ago | bioprocessintl.com | Shreeyashi Ojha

Piramal facility expansionstock.adobe.comAt its Lexington, Kentucky site – specializing in sterile compounding, liquid filling, and lyophilization for injectable drugs – the Indian CDMO is adding 24,000 square-feet of manufacturing space and a new lab. The expansion includes a new filling line, two commercial-scale lyophilizers, an external vial washer, and a special capping machine. The facility is expected to open by late 2027.
Genentech building $700m fill/finish plant in NC

1 month ago | bioprocessintl.com | Dan Stanton

Roche is building a $700m fill/finish plant in Holly Springs, North CarolinaDepositPhotos/ellandarLast month, Swiss biopharma giant Roche announced plans to invest $50 billion across its US network, both in pharmaceutical and diagnostics R&D and manufacturing. Among the projects, the firm laid out plans to build a gene therapy facility in Pennsylvania and to expand/upgrade manufacturing and distribution capabilities in Kentucky, Indiana, New Jersey, Oregon, and California.
Imunon looks to DNA vaccine tech to support ovarian cancer immunotherapy

1 month ago | bioprocessintl.com | Dan Stanton |Josh Abbott

Imunon looks to DNA vaccine tech to support ovarian cancer immunotherapyDepositPhotos/drecunThe New Jersey-based biotech is developing non-viral DNA technology for various modalities. Its lead candidate is IMNN-001, an immunotherapy for ovarian cancer, based on the firm’s TheraPlas platform.
CDMO ReciBioPharm taps NewBiologix to bolster AAV offering

1 month ago | bioprocessintl.com | Shreeyashi Ojha

Swiss firm NewBiologix (NBX) has licensed its Xcell-Eng-HEK293 cell line to contract development and manufacturing organization (CDMO) ReciBioPharm for development and production of adeno-associated virus (AAV) therapies for clinical trials. According to the cell and gene therapy (CGT)-focused NBX, its licensed cell line boosts recombinant AAVs manufacturing by combining multidimensional digital polymerase chain reaction (PCR) with third-generation sequencing.
Astraveus, NecstGen team up to tackle CGT bottlenecks

1 month ago | bioprocessintl.com | Shreeyashi Ojha

The Netherlands Center for the Clinical Advancement of Stem Cell and Gene Therapies (NecstGen) will assess Paris-based firm Astraveus’ Lakhesys benchtop cell factory, which is a chimeric antigen receptor (CAR)-T therapy manufacturing technology. As per the agreement, the partnership aims to use the cell factory to cut costs and increase efficacy in CAR-T production. Additionally, NecstGen will manufacture lentiviral vectors (LVVs) for R&D.
Amgen ploughing $900m into Ohio production site

1 month ago | bioprocessintl.com | Dan Stanton

Amgen US investmentstock.adobe.comIn March 2024, Amgen opened a 270,000 square-foot facility in New Albany, Ohio supporting its manufacturing network through the addition of assembly and final product packaging capabilities. The site, first touted in 2021, saw an investment of $365 million.