Outsourcing

The company will now include GMP cell-based potency assays at its Cambridge, UK, and San Diego, Calif., sites expanding its early and late phase analytical capabilities.

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.

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.

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.

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

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

Results from the CPHI annual survey show that 49% of industry respondents are “highly positive” on the contract services sector seeing growth over the next 18 months.

Under the long-term supply agreement, Lonza will manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

Rentschler Biopharma now offers a new lentiviral vector manufacturing toolbox at its site in Stevenage, UK.

As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.

Pluri’s newly launched CDMO business will manufacture two novel cell therapy product candidates for Kadimastem.

With the acquisition, Olink will join Thermo Fisher’s Life Sciences Solutions business.

This collaboration aims to support and accelerate clinical development of advanced and novel technologies.

The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.

Swiss CDMO CordenPharma and Spain-based Certest will collaborate on the development of ionizable lipids for LNP formulations.

Asking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.

Enzene's new division will provide end-to-end integrated discovery services.

Under this partnership, AGC Biologics and BioConnection will provide development and manufacturing capabilities for biopharmaceutical drug substance and drug product.

This article looks at the relationship between a CDMO quality organization and the client.

The Mirus Bio acquisition will boost Merck KGaA’s viral vector manufacturing services.

The need for preclinical testing expertise is growing as molecular complexity increases.

The rising demand for biologics and technological innovations are driving blow-fill-seal capacity, harnessing manufacturing efficiency, and benefitting patients.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

Key areas to invest include manufacturing process improvements, quality management, and AI.

Contract manufacturer SK pharmteco will manufacture as well as conduct testing and release of Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg), a gene therapy for bladder cancer.

As the industry adjusts to new regulations, including Annex 1, bio/pharma manufacturers must rethink facility designs to remain in compliance.