Manufacturing roundup: Symeres buys CRO in New Jersey; Cambrex invests $16M+ in Minnesota and Iowa facilities

27 Oct 2022
endpts.com
Gene TherapyCell TherapySmall molecular drugAcquisitionCollaborate
Dutch CDMO Symeres has acquired a company to further strengthen its position in the US. The company is buying Exemplify BioPharma, a CRO that provides drug development services, formulation development and CMC services to customers. Exemplify also has an 18,000-square-foot facility in Cranbury, NJ where the CMC services are done. Under the deal, which began in talks last year, Exemplify will maintain its leadership structure for its roughly 20 employees as it moves into Symeres’ fold, according to Symeres. In an email to Endpoints News, Symeres CEO Eelco Ebbers said the acquisition was a perfect fit for the company’s strategy. “Our strategy is based on strong organic growth with existing services and sites, complemented with an active acquisition strategy for complementary services in dedicated areas that are closely connected with existing services, or in certain regions. Exemplify’s services and expertise are a good complementary fit to Symeres’ existing development services in process R&D and GMP production.” Ebbers also said that over 40% of the company’s business originates from US-based companies, and with the acquisition, it can increase the support of its US-based customers. To boost its US presence, Symeres already acquired Organix, based in Woburn, MA, earlier this year. The deal is expected to close in a few weeks, according to Ebbers. After capping an expansion in North Carolina, Cambrex is moving its focus to the Midwest part of the US. The company announced that it is investing $16.5 million in two projects in Iowa and Minnesota. First, the company is planning to create a 21,000-square-foot R&D facility in Minneapolis. This will expand the capacity for small molecule development and manufacturing. The site will be near the Minneapolis-St. Paul airport and will conduct analytical and chemical development for drug candidates. The site will also act as an extension of Cambrex’s facility in Charles City, Iowa. The project is expected to add around 40 jobs in Minneapolis over the next two to three years. At the same time in Charles City, Cambrex is launching a 9,000-square-foot expansion and a 21,000-square-foot renovation project at the API manufacturing site. The Charles City expansion will add a new QC laboratory and office space, as well as add 40 jobs. The project will also “modernize” the AC and R&D facilities as well. The Iowa Economic Development Authority (IEDA) has also awarded the company tax benefits and $300,000 in direct financial assistance in support of the project. “Our new facility in Minneapolis will double our analytical and chemical development footprint in the Midwest, providing clients with easy access to state-of-the-art capabilities and top scientific experts. We continue to invest in our U.S.-based footprint to support the demand for high-quality API development and manufacturing,” said Thomas Loewald, CEO of Cambrex, in a statement . ABL, a French CDMO, has entered a strategic partnership with another French CDMO, RD-Biotech. The partnership will provide GMP manufacturing for cell and gene therapies. The deal will see RD’s manufacturing services combined with ABL’s production of viral vectors to provide end-to-end services for cell and gene therapy companies. The agreement will allow customers to have the option to use each company as a single supplier and work with each CDMO independently. “ABL’s partnership with RD-Biotech is a major step forward in enabling our company to roll out our ‘Gene to Cell’ strategy, aimed at offering all-in-one services to our customers whatever their needs are in Adeno Associated Virus-based (AAV) and lentivirus GMP manufacturing,” said Thierry Van Nieuwenhove, CEO of ABL, in a statement. The move comes as RD is planning to open a new facility next year to manufacture plasmid DNA and ABL is producing an “in-house AAV platform” along with opening a new facility to produce gene therapies. Landmark Bio has opened a new biomanufacturing facility in Watertown, MA. The 44,000-square-foot facility will test and manufacture cell and gene therapies made by the company and has eight cleanrooms to produce cell therapies, viral vectors, mRNA and lipid nanoparticles. It also has an area for fill-and-finish operations and QC testing. The facility will also provide services such as drug development, regulatory counseling and other support services. It also has around 60 staff members at present and will look to grow to 100 over the coming years. “Landmark Bio is a unique venture bringing together the best of academia, industry, and research hospitals to translate groundbreaking research into life-changing therapies,” said Ran Zheng, Landmark Bio’s CEO, in a statement . Mylan Institutional is pulling its octreotide acetate injection, in 500ml dosage, off the shelves. The recall is being issued, according to the FDA, due to a “product complaint” of glass particles in a syringe. The drug was made by Italfarmaco SpA, Italy, and was distributed by Mylan Institutional LLC in the US between Jan. 11 and June 21 of this year. The drug is used to reduce blood levels of growth hormone and insulin growth in acromegaly patients as well as treat patients with metastatic carcinoid tumors in certain cases. While the presence of glass in an intravenous drug can lead to several issues, including irritation, swelling, allergic reactions and microvascular obstructions, the FDA has so far not received any reports of “adverse reactions” for the recalled drugs. The FDA is encouraging wholesalers and retailers to examine inventory to see if the drug lot is in stock or has been distributed.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.