UNITED KINGDOM – Sterling Pharma Solutions, a contract development and manufacturing firm, has announced a £10 million (US$13.5 million) multi-year investment strategy for its Dudley, UK, facility.
This latest investment, which is part of Sterling’s multi-year investment strategy at its Dudley site, will include the construction and commissioning of new process development laboratories, as well as the installation of additional commercial-scale manufacturing equipment to meet growing demand for small-molecule API manufacturing.
The project, which is expected to be completed in mid-2022, includes the installation of a 4.5 cubic metre hydrogenator capable of pressure reactions up to 10 bar, as well as supplemental conical and filter dryers within the existing manufacturing plant.
In addition, new kilo-scale and technology laboratories will be built in the site’s Material Science Centre, which was built as part of the investment strategy in 2020.
The laboratories will be outfitted to develop commercial-scale biocatalysis processes for customers, as well as to expand capabilities at the recently established flow chemistry center of excellence.
Commenting on the development, Kevin Cook, Sterling CEO, said: “The next phase of our strategic plan is to increase and enhance our capacity to develop and scale up processes for commercial readiness, and is testament to the continued, strong interest that we are seeing in small molecule development.”
CDMO companies scaling up
Pharmaceutical Ingredient (API) production and keep up with the surging demand.
In October, FUJIFILM Diosynth Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and viral vectors established the largest cell culture biopharma facility in North America.
The new facility will offer large-scale cell culture manufacturing of bulk drug substance production with large bioreactors with the potential to expand based on market demand.
In the same month, Bionova Scientific a CDMO with extensive protein production, cell line development, opened a commercial-ready fully single-use GMP biologics manufacturing center at its headquarters in Fremont, USA.
The GMP-compliant facility will enhance the company’s service offerings to the biotherapeutics industry while also assisting it in meeting the growing demand for industrial biomanufacturing capacity.
Rentschler Biopharma SE, a global CDMO for biopharmaceuticals formed a partnership with XL-protein, a privately held biopharmaceutical company to develop a long-acting, hyperactive recombinant human deoxyribonuclease I (DNase I).
Still in October, GTP Bioways, a CDMO specializing in biotherapies and nanotherapies splashed US$14 million in two new biopharmaceutical production lines at its Toulouse, France.
Also, Aenova announced a significant increase in cutting-edge aseptic production area at Latina, Italy, facility featuring a completely new high-speed flexible line for vials and prefilled syringes (PFS), as well as a completely new compounding area.
With around 600 employees, the Aenova site in Latina is one of the Aenova Group’s largest production sites, producing and distributing pharmaceutical products worldwide.
However, the industry is far from mature. The industry can expect continued rapid growth with the explosion of the drug-development pipeline, record funding for emerging biopharma companies, and vast new opportunities such as gene and cell therapies.