In this interview, David Phasey from 3P innovation highlights why advanced technologies are critical to helping companies overcome the challenges associated with the development and manufacture of next-generation therapies.

Despite the numerous challenges facing the development, manufacture, and commercialization of next-generation therapies, the end value proposition they offer is significant and worth the effort from stakeholders.

With digitalization gaining traction in biomanufacturing, The Pharma Navigator speaks to experts about how digital twins and advanced modeling are helping companies meet industry demands and what that means for the workforce.

While meaningful progress has been made by the biopharmaceutical industry into digitalization, there is still a lot of work to do to achieve a true digital transformation.

The grant money will be used by the biotechs to develop innovative targeted lipid nanoparticles that contain novel immune-silent DNA constructs for in vivo CAR T therapy.

The strategic investments by the CRDMO, which are aligned with its long-term strategy, will strengthen its integrated oligonucleotide platform and capabilities to delivery ADC solutions.

The location of the facility has been purposefully chosen to be as central as possible to cell and gene therapy companies located across the U.S. and will allow the company to meet growing demand for pDNA development and manufacturing services.

FDA has granted approval to Viatris for its generic intravenous iron replacement product as a treatment of iron deficiency anemia in adult and pediatric patients with chronic kidney disease.

If the oral antibiotic gains regulatory approval, patients who are 12 years of age and older in the U.S. suffering from urogenital gonorrhea will have an alternative, non-invasive treatment option.

This latest FDA leadership appointment comes as the agency focuses on balancing regulatory challenges with opportunities for accelerated patient access.

This partnership will leverage BioDuro’s expertise and Atombeat’s in silico modeling know-how to launch an AI-powered platform that allows for accelerated development of next-generation peptides.

D’Herve has succeeded Dr. Singh, bringing a wealth of industry experience to the position, having previously served in senior positions at Evonik.

Strategic early planning, optimal CDMO selection, careful scale management, and stringent quality, along with greater industry collaboration, will ensure future biomanufacturing success.

Recent fatalities in clinical trials for gene therapies have led to greater regulatory scrutiny and concerns over safety, particularly in relation to the use of viral vectors, leading industry to question whether a potential therapeutic reinvention is needed.

The companies will work together, leveraging Syntekabio’s AI prediction platform for virtual screening to uncover new, high-potential indications for MetaVia’s DA-1241 oral therapy.

Through this acquisition, ESTEVE will expand its contract development and manufacturing services for small-molecule APIs from pre-clinical through to commercial manufacturing within the U.S.

The strategic collaboration will also provide GSK with an exclusive worldwide license for Hengrui’s potential best-in-class PDE3/4 inhibitor, which is in clinical development as an add-on maintenance treatment for COPD.

Pegcetacoplan (EMPAVELI), which was shown to be safe and effective in a Phase III clinical trial, is now approved for the treatment of U.S. patients 12 years and older with C3G and primary IC-MPGN.

The strategic collaboration and license agreement is potentially worth more than USD 1 billion and offer patients less burdensome treatment regimens through sustained ocular delivery of therapies.

In efforts to position itself for long-term growth, Rocket is reducing its company headcount, undergoing a structural reorganization, and prioritizing late-stage AAV cardiovascular programs.