WuXi Biologics Updates Expansions; Berkshire Sterile Manufacturing ExpandsBy
The latest news from CDMOs, CMOs, and suppliers featuring news from WuXi Biologics and Berkshire Sterile Manufacturing.
WuXi Biologics Provides Update on Global Mfg Expansions
In its first-half earnings release, WuXi Biologics, a contract biologics manufacturer, provided an update of its global manufacturing expansions with a target of having total capacity to exceed 280,000 liters by 2022. The company also noted its previously announced plans to expand construction of a new integrated biologics conjugation solution center for antibody-drug conjugates.
WuXi says the company’s construction projects are on track with MFG4, its facility in China using a 4,000-liter disposable bioreactor, and DP4, a robotic sterile filling facility for biologics in China, with both becoming GMP operational last month (July 2019). The company says its Ireland site is expected to be GMP ready in 2021 to support the European and US markets. In 2018, the company announced plans to invest EUR 325 million ($392 million) in a new biologics drug-substance manufacturing facility in Mullagharlin, Dundalk, County Louth, Ireland.
Source: WuXi Biologics
Formulation Development/Drug Product Manufacturing
Berkshire Sterile Manufacturing to Expand Injectable Production Capacity
Berkshire Sterile Manufacturing, a fill–finish contract manufacturer for injectable medications, has announced plans to add a third isolator line, where the injectable medications are filled, to expand capacity at its facility in Berkshire County, Massachusetts.
The company currently has two isolators in operation with a fill rate of up to 1200 units/hour. Berkshire says the third line will contain a flex filler with the ability to fill at a rate of 3,000 units/hour depending on container and fill volume. The isolator and filling line will be linked to a depyrogenation oven (sterilization by heat), allowing for bulk vial use, with a vial washer located on the loading side of the oven. A rapid decontamination chamber will be included in the isolator for the introduction of pre-sterilized containers, and a high capacity lyophilizer (capable of producing 20,000 freeze-dried vials) will be also be connected to the isolator.
The company will also add a second ventilator autoclave (sterilization by pressurized steam) and a new water for injection system (sterile water system) to the manufacturing area to provide redundancy in the company’s systems. The company says inspection will also be updated with a semi-automated inspection system to handle the greater volume of product.
Berkshire says the additions will be completed in 2020 to early 2021 and will create 60 high-salary positions.
Source: Berkshire Sterile Manufacturing