Manufacturing

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.

The Novo Nordisk Foundation has committed DKK 600 million (US$87.4 million) towards the initial costs of the center housing the new supercomputer, which has the potential to accelerate drug discovery innovation.

The collaboration aims to develop precision genetic medicines using ViaNautis’ proprietary polyNaut technology platform.

The company is investing $76 million to increase ADC manufacturing capacity at its St. Louis, Mo. facility.

Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.

The importance of proper analysis of HCPs in the biomanufacturing process was discussed by Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, at AAPS PharmSci 360.

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

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 at AAPS PharmSci 360.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

The establishment of this new center aims to expedite R&D processes, reduce costs, and potentially lead to accelerated discovery of new candidate therapies.

The new center's design will prioritize integration of the entire supply chain, with the aim of accelerating product development and autonomous production capacity in alignment with EU priorities.

SK pharmteco will be the preferred manufacturing partner for AVG-101, AaviGen’s lead gene therapy product.

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

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.

At CPHI Milan, Nicolas Camper, senior director—Bioconjugation Chemistry, Abzena, spoke about new developments in ADC technologies, including the role of complex chemistries.

Solving the challenge of better-stabilized temperature-sensitive biomolecules hinges on innovative formulation strategies.

Thermo Fisher Scientific's launch of its Accelerator Drug Development follows expansions of sites in Cincinnati, Ohio, and Bend, Ore., earlier in 2024 to enable R&D, manufacturing, and testing.

At this year's CPHI Milan, Camille Dumont, PhD, manager, customer applications, Lonza, discussed current industry trends that are impacting oral solid dose formulation work.

At CPHI Milan, Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment to stay compliant with current regulations.

Space-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.

At CPHI Milan, Stacey Treichler, senior director of global marketing and strategy, Purolite, an Ecolab company, spoke about current trends in the biopharma industry and innovations in purification resins .

The annual survey predicts that four of the five biggest biologics capacity holders in 2028 will comprise CMOs, which will control 45% of all CMO capacity in Asia.

Cellevate's nanofiber microcarriers are the first on the market for use in manufacturing viral vectors used in gene therapy production, according to the company.

During Bio 2024, Aaron Cowley, PhD, chief technical officer and co-founder, Captozyme, discussed the advancement in development of microbiome-derived therapeutics.

SGD Pharma plans to showcase its siliconized molded glass vials at CPHI Milan as part of its range of sustainable products and services.