Lonza Issues Update on China Ops; Hitachi, Vetter, LSNE ExpandBy
The latest news from CDMOs, CMOs, and suppliers featuring Lonza, Vetter, LSNE, Azelis, and Hitachi Chemical Advanced Therapeutics.
Chemicals/Chemical API Manufacturing
Azelis India To Acquire S. Zheveri’s Distribution Business
Azelis, a provider of active pharmaceutical ingredients, excipients, specialty chemicals and food ingredients, has agreed to acquire 100% of the distribution and Indent business of S. Zhaveri Pharmakem, an Indian specialty distributor for the pharmaceutical industry, to increase Azelis’ India’s capacity.
S. Zhaveri is 100% owned by the Javeri family and all its employees in the distribution business will become part of Azelis. Following the closing, both Uma Javeri, Managing Director, S. Zhaveri Pharmakem, and Sonali Sheth, Associate Director, S. Zhaveri Pharmakem, will support the integration of S. Zhaveri Pharmakem’s distribution business into Azelis and will lead the entire pharmaceutical business of Azelis in India.
The closing of the transaction is expected within the next few weeks as of February 3, 2020.
Hitachi Opens New Cell and Gene Therapy Mfg Facility in New Jersey
Hitachi Chemical Advanced Therapeutics Solutions, a cell-therapy CDMO and a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemical’s Regenerative Medicine Business Sector in North America, is opening a new cell- and gene-therapy manufacturing facility in Allendale, New Jersey. The new facility more than doubles HCATS’ existing manufacturing capacity in New Jersey.
The facility currently includes six classified environment rooms, with the capacity to add more rooms that can be reconfigured. The new facility includes manufacturing development laboratories, quality control and microbiological laboratories, warehousing, executive offices and meeting space. The new facility will require up to 500 more employees to reach full operational capacity over the next several years.
Hitachi Chemical has operations in North America (Allendale, New Jersey and Mountain View, California), Europe (Munich, Germany), and Japan (Yokohama).
Source: Hitachi Chemical Advanced Therapeutics Solutions
Formulation Development/Drug Product Manufacturing
Vetter Combines Development Labs at Ravensburg, Germany Site
Vetter, a CDMO of aseptic filling and packaging, reports that it combined its development laboratories into one Ravensburg, Germany site as of the end of 2019. The services at the 1,800-square-meter building include process development as well as functional and specification testing of packaging systems, chemical-analytical and biochemical analysis, and particle characterization. Non-GMP laboratory space and equipment combined with a GMP analytical laboratory allows for increased capacity and optimized work spaces.
At present, more than 50 employees work in the new labs. Prior to the bundling of its laboratories, the development studies and the corresponding analytical services for testing during process or packaging material development took place in several labs at different locations in Ravensburg and Langenargen, Germany. The company says by sequencing these services, processes have been synchronized. The company says that expansion will continue within the building throughout 2020 and includes more lab space and the provision of additional analytical equipment and lyophilizer capacity. Vetter is also working on capacity expansion in filling and secondary packaging of injectables at all its sites.
LSNE Expands Vial Filling and Lyophilization Capacity
LSNE Contract Manufacturing, a CDMO of fill–finish and lyophilization services, broke ground on a 26,000-square-foot addition of its existing facility at its Bedford, New Hampshire campus, to increase commercial drug-product manufacturing capacity.
The addition will feature a high-speed six head Bausch+Ströbel aseptic vial-filling line, Ziel isolator, and multiple large-scale commercial freeze-dryers with automated loading/unloading.
LSNE currently has six GMP facilities—four located in New Hampshire, one in Wisconsin, and one located in León, Spain. LSNE specializes in process cycle development, fill– finish and lyophilization (for vials, pre-filled syringes and dropper bottles for ophthalmics), and analytical testing.
Lonza Provides Update on Operations After Coronavirus Outbreak
Lonza has provided an update to its operations in China in the wake of the outbreak of the coronavirus. The company reports that since the outbreak of the coronavirus in the Hubei Province in China, Lonza has monitored the development of the outbreak and taken measures to safeguard its employees and supply chain at its sites located in China.
Lonza’s production sites in China include Nanjing, Jiangsu Province (Lonza Specialty Ingredients [LSI] formulation and pyromellitic dianhydride production); Nansha, Guangdong Province (Lonza Pharma Biotech & Nutrition [LPBN] small-molecule active pharmaceutical ingredients), LSI niacin production); Suzhou, Jiangsu Province (LPBN capsules and LSI microbial control solutions); and Guangzhou, Guangdong Province (LPBN mammalian manufacturing). The Guangzhou site is currently under construction and is not yet operational. Lonza does not have a production facility in Hubei Province.
Lonza reports that most of its facilities in China decided to extend the Chinese New Year holiday period into the week of February 3, 2020, pending further guidance from local authorities, and are currently not operating. Lonza has continuous operations at some facilities that were not shut down over the holiday period, and these processes continue.
The company reports that customers who may be affected by the extended closure are being informed on a case-by-case basis, but presently it expects there to be limited disruption. As the outbreak progresses, Lonza is assessing the impact of potential delays to raw material delivery and finished goods delivery across its global facilities.
Lonza also reports that it has taken measures to protect its employees and any third parties visiting its sites in China. Measures include temperature checks and the provision of disinfectants and personal protection devices (such as face masks). The company has also implemented restrictions on business travel to, from, and within China. For any employees travelling from China to another country, the company has implemented a 14-day stay-at-home policy upon arrival to prevent any potential spread of the virus. The company says its employees are well-informed of the risks with regular global updates and are cooperating fully with preventative measures.