Manufacturing

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

EXO Biologics and its subsidiary, ExoXpert, have received GMP certification of a European exosomes manufacturing facility 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.

As biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.

Jason Bock, co-founder and CEO of CTMC, discusses the industry impact and manufacture of patient-centered medicines.

Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.

Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.

Fluorescence spectroscopy offers unique advantages for characterizing EVs.

With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.

The company officially launched new production suites, a revamp of its development labs, and more at its Thousand Oaks, Calif., cell therapy manufacturing facility.

With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.

Webinar Date/Time: Thu, Dec 5, 2024 11:00 AM EST

The investment will allow Sanofi to strengthen antibody bioproduction at its Lyon Gerland site in France.

Webinar Date/Time: Thursday, December 5th, 2024 at 11:00 AM EST

Under the collaboration, the companies will create and test circVec DNA–LNP formulations with an eye toward potential therapeutic applications.

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

Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.

With financing led by OrbiMed, Novo Holdings, and Jeito Capital, Alentis Therapeutics will develop a pipeline of Claudin-1-targeted ADCs to treat solid tumors.

Empowered by a $1.5 billion commitment from a major investor, Frontier Scientific Solutions has unveiled its plans for establishing a global free trade zone gateway intended for facilitating the life sciences supply chain using Wilmington International Airport in North Carolina.

Avantor has launched its new, expanded Innovation Center in Bridgewater, NJ, with integrated workflows under one roof and purpose-built collaboration spaces.

Avantor executives discuss the future of the biopharmaceutical industry and the impact that a wave of next-generation biotherapeutics will bring.

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

TrakCel's OCELLOS, an IT platform, has been selected to orchestrate the administration of five out of seven autologous or matched allogenic cell therapy products approved or expected to be approved in 2024.

With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.

Lonza’s Synnafix has licensed its ADC technology to BigHat Biosciences, which will combine it with its ML design platform to generate newly designed ADCs.