Manufacturing

LNPs have gained solid ground as a drug delivery system for mRNA due to their success in the vaccines arena.

Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

Through the agreement, Cambrex will provide accelerated access to clinical development capabilities to Lilly’s biotech collaborators.

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.

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

The ROSS Model 42N-10 has a working capacity of 10 cubic feet and is designed for free-flowing materials with bulk densities up to 100 lbs per cubic foot.

Datwyler has launched new coated plungers in its NeoFlex line that are suitable for large volume biologics.

Through this acquisition, the German CDMO expands its global network and adds aseptic fill/finish and lyophilization expertise to its sterile manufacturing capabilities.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

The Thousand Oaks, Calif., cell therapy manufacturing facility now houses new production suites, updated development labs, and more after expansion.

The $3.6 million investment will allow the CDMO to boost its advanced labeling, automated visual inspection, and fill/finish capabilities.

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

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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.

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.

Ascend is partnering with EW Healthcare Partners to expand capabilities in the United States.

Evolving industry demands are driving the need for greater flexibility and innovation in processing equipment for pharmaceutical manufacturing.

The companies will work to create climate-friendly pMDIs using Orbia’s low global warming potential propellant.

Pharmaceutical training programs are enhanced by integrating ICH quality risk management considerations.

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

Shifting to automated, closed modular manufacturing systems is growing increasingly crucial for biopharmaceutical production.

Capturing and curating R&D data are crucial to realizing the full value of advanced analytics.

The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication.