Feliza Mirasol

EXO Biologics and ExoXpert, an EXO Biologics subsidiary, have received GMP certification of a European manufacturing facility for exosomes and have successfully loaded mRNA and DNA payloads into GMP-grade exosomes for drug delivery.

With its new offering, Lonza can tailor services to support smart capsule companies with its bi-layer capsule manufacturing technology.

The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.

Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France.

The companies will collaborate to create and test circVec DNA–LNP formulations for use in potential therapeutic applications.

Located in German, Italy, and Lithuania, the new European facilities will specialize in drug discovery and R&D services.

SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.

Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.

FDA's approval of eladocagene exuparvovec-tneq (Kebilidi) makes that product the first FDA-approved gene therapy for treating AADC deficiency.

Frontier Scientific Solutions has unveiled plans to use a $1.5 billion commitment from a major investor to create a global free trade zone gateway to facilitate the life sciences supply chain using Wilmington International Airport in North Carolina.

Avantor's newly launched expanded Innovation Center in Bridgewater, NJ, is designed for integrated workflows and features purpose-built collaboration spaces.

Executives at Avantor talk about the future of the biopharmaceutical industry and the anticipated impact that a wave of next-generation biotherapeutics will bring.

Under an ongoing partnership with Merck, known as MSD outside of the United States and Canada, Ginkgo Bioworks has achieved the first milestone in a project aimed at improving biologics production.

Manufacturers of five autologous or matched allogenic cell therapy products have selected TrakCel's IT platform, OCELLOS, to orchestrate the administration of these therapies, which are approved or expected to be approved in 2024.

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

In the collaboration, the new company, Oblenio Bio, has been granted an exclusive option to license LBL-051, a tri-specific T-cell engager antibody, from Leads Biolabs.

Synaffix, a Lonza company, has licensed its ADC technology to BigHat Biosciences to be combined with the latter's ML design platform to develop new ADCs

With DKK 600 million (US$87.4 million) in funding from the Novo Nordisk Foundation, the new supercomputer offers the potential to accelerate innovation in drug discovery.

The partnership will use ViaNautis’ proprietary polyNaut technology platform to develop genetic medicines that can precisely target tissue types.

The collaboration aims to advance clinical development of a Phase I drug candidate, MRT-6160, and to explore other therapeutic opportunities across multiple indications.

Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, talked about the importance of properly characterizing HCPs in the biomanufacturing process.

At AAPS PharmSci 360, Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, discussed lipid-based formulations and tackling bioavailability challenges for oral biologics.

Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, spoke on recent challenges and trends in softgel formulations.

Bala Addepalli, PhD, Director, R&D New Modalities Portfolio, Waters Corporation, discussed trends in new analytical tools for RNA characterization and gave highlights of his talk at AAPS PharmSci 360.

Bala Addepalli, PhD, Director, R&D New Modalities Portfolio, Waters Corporation, discussed recent advancements and current challenges in the development of large RNA therapeutics.

Merck will deploy Mestag’s proprietary RAFT platform to investigate the pathogenic role that fibroblasts play in inflammatory diseases.

Evonik won the CPHI Excellence in Pharma Award in the “Sustainability” category in recognition of its plant-based squalene, PhytoSquene, used in parenteral drug delivery applications.

Nicolas Camper, senior director—Bioconjugation Chemistry, Abzena, discussed new advancements in ADC technologies, including the role of complex chemistries.

According to the annual survey, four of the five biggest biologics capacity holders in 2028 will comprise CMOs, which are expected to have 45% of all CMO capacity in Asia.