Supplier News: Asymchem, Thermo Fisher, Rovi & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Asymchem, Snapdragon Chemistry, Angus Chemical Company, Thermo Fisher Scientific, Avantor, National Resilience Inc., Skyepharma, Goodwin Biotechnology,Rovi, Catalent, and Curia.
Chemicals/Chemical API Manufacturing
Asymchem To Acquire Continuous Mfg Company Snapdragon
Asymchem, a Tianjin, China-headquartered CDMO, has agreed to acquire Snapdragon Chemistry, a Waltham, Massachusetts-based provider of flow-chemistry process design and technology development services, for $57.94 million.
Snapdragon will operate as a stand-alone Asymchem division. It will continue with its ongoing lab and manufacturing expansion at its facility in Waltham to add additional capacity to support larger, pilot-scale manufacture. The deal is expected to close in the second quarter of 2022, pending regulatory approval.
The two companies began collaborating in the fall of 2020 when Asymchem announced an investment in Snapdragon to help expand its drug-substance manufacturing suites. This acquisition will further streamline the transition of projects from early to late-stage manufacturing and commercialization.
Angus Completes Expansion of Louisiana Mfg Site
Angus Chemical Company, a manufacturer and marketer of specialty chemicals for the life- sciences and industrial markets, has expanded its Sterlington, Louisiana, manufacturing facility to include commercial production of tris amino hydrochloride products.
Tris amino HCl is used as a diagnostic reagent and as a downstream processing buffer in the purification of commercial bio/pharmaceuticals. Tris amino HCl products are produced by Angus in its Sterlington facility. In addition, Angus operates a dedicated life-sciences warehouse, quality-control laboratory, and filling and packaging center in Sterlington.
Source: Angus Chemical Company
Thermo Fisher Investing $40 M at Single-Use Materials Site
Thermo Fisher Scientific is investing $40 million to expand its single-use technology manufacturing facility in Millersburg, Pennsylvania.
The expansion is part of the company’s $650-million multi-year investment, announced last year (2021), to help ensure bioprocessing production capacity for materials used in developing new and existing biologics and vaccines, including for COVID-19.
Thermo Fisher acquired the Millersburg facility in 2015, and over the last two years (as reported on February 15, 2022) has expanded and modernized the warehouse and cleanrooms. The second phase of the site expansion includes a new, 47,000-square-foot warehouse and creation of 100 new jobs at various levels. Once fully renovated by mid-2023, Thermo Fisher says it anticipates that the site will employ more than 1,000 people.
Source: Thermo Fisher Scientific
Resilience in Supply Pact with Takeda
National Resilience Inc., a recently launched manufacturing and technology company for biologics and advanced therapies, has entered into a manufacturing services agreement with Takeda’s Plasma-Derived Therapies Business Unit.
Resilience will support the development and manufacture of multiple products in Takeda’s plasma-derived medicines portfolio out of its facility in Mississauga, Ontario, Canada.
Resilience’s 136,000-square-foot biomanufacturing facility in Mississauga provides process and analytical development, scale-up, drug-substance and drug-product fill–finish manufacturing.
Goodwin Biotechnology Appoints New CEO
Goodwin Biotechnology, a Plantation, Florida-based biologics contract manufacturer, has appointed Darrin Schellin, formerly Senior Vice President, Global Head Drug Product & US Drug Substance Operations at Siegfried, as CEO. Mr. Schellin will also be inducted as a member of the company’s Board of Directors.
Mr. Schellin has had a career in the life sciences industry spanning several decades. After supply chain and operations management assignments with Culligan and Bausch & Lomb, he was part of the leadership team at Alliance Medical Products as Chief Operating Officer and then CEO, until it was sold to the Swiss CDMO, Siegfried Holding AG. Mr. Schellin then ran Siegfried’s global drug products business for six years, managing five sites across the US and Europe.
Source: Goodwin Biotechnology
Formulation Development/Drug-Product Manufacturing
Skyepharma, MaaT Pharma Partner for Drug-Product, Microbiome Mfg
Skyepharma, a CDMO of drug products, and MaaT Pharma, a clinical-stage microbiome therapeutics company, have entered a partnership to establish an ecosystem microbiome therapies manufacturing facility in Saint-Quentin-Fallavier, France.
The facility will be part of the SkyeHub Bioproduction, a dedicated location by Skyepharma’s current facility for oral solid dosage forms, which occupies 22,000 m², on a 60,000 m² piece of land. Skyepharma has decided to allocate a portion of the available land (more than 20,000 m²) to establish its SkyeHub Bioproduction, which is designed to offer clinical and commercial production capacities to biotech companies.
The partnership will provide MaaT Pharma with a dedicated 1,500-square-meter site, which could be increased to 3,000 square meters depending on manufacturing needs, to support clinical and eventual commercial development of select drug candidates. The facility will annually produce several thousand enemas of the company’s lead candidate (MaaT013) for treating Graft-versus Host disease and several hundreds of thousands capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation. The new plant will also allow MaaT Pharma to accelerate the development of MaaT03X, a portfolio of drug candidates, which uses its proprietary microbiome ecosystem co-fermentation technology.
Under the agreement, which follows a bilateral letter of intent signed in September 2021 and whose financial conditions remain confidential, MaaT Pharma will have a dedicated facility and construction will be financed by Skyepharma. The production site is expected to be operational in 2023. In addition to providing the building, Skyepharma will also provide its expertise in product quality standards, regulatory affairs, certification, and large-scale production.
Source: MaaT Pharma
Rovi Extends Supply Pact with Moderna, Plans Expansion
Moderna and Laboratorios Farmacéuticos Rovi (Rovi), a pan-European pharmaceutical company and CDMO, have entered into a long-term collaboration to increase capacities for the compounding, aseptic filling, inspection, labeling, and packaging of Rovi’s facilities in Madrid, Spain.
This new agreement, which has a term of ten years, includes a series of investments to acquire new equipment and adapt the present Rovi drug product fill–finish facilities and production lines in Spain. In addition to producing Moderna’s COVID-19 vaccine, Rovi’s platform could also be used to service future Moderna mRNA vaccine candidates.
Moderna and Rovi are expected to finalize details of this agreement in the first quarter of 2022.
Catalent To Expand Clinical Supply Capacity in China
Catalent plans to expand its Waigaoqiao facility in Shanghai, China to increase capacity for temperature-controlled storage and distribution of clinical supplies and for additional secondary packaging capabilities.
The facility will be expanded by approximately 30,000 square feet, which will double the clinical storage capacity and allow the installation of additional refrigerated and deep-frozen storage. The expansion and commissioning are expected to be completed by mid-2022.
The Waigaoqiao facility is one of two clinical-supply facilities that Catalent operates in Shanghai, the other being located in Tangzhen.
Thermo Fisher Launches Cell, Gene-Therapy Packaging Services
Thermo Fisher Scientific has launched new cell- and gene-therapy integrated commercial packaging and distribution services.
The Patheon Commercial Packaging Services for Cell and Gene Therapies (CGT) is an end-to-end solution combining the storage, serialization, ultracold and cryogenic packaging, and global distribution.
These new services complement the company’s development and manufacturing capabilities for cell and gene therapies, which include translational biology, process development, and batch manufacturing services. Full details of the new services can be found here.
Source: Thermo Fisher Scientific
Curia Fully Integrates Integrity Bio, LakePharma
Curia (formerly AMRI) reports that that Integrity Bio and LakePharma, two companies that it acquired last year (2021), have fully transitioned to the Curia brand.
Integrity Bio is a Thousand Oaks, California-based CDMO of drug-product formulation development and fill–finish services. LakePharma is a San Carlos, California-based biologics contract research, development and manufacturing organization with operations in California, Massachusetts, and Texas.
This change reflects the organizational integration of the acquired companies into Curia. Curia completed the acquisition of Integrity Bio in August 2021 and closed the LakePharma transaction in September 2021.
Avantor Breaks Ground on New Distribution Center
Avantor, a supplier of ultra-high-purity materials for the life-sciences and advanced technology industries, has started construction on a distribution center to expedite access to production materials for bio/pharmaceutical manufacturers in Ireland.
Expected to open later this year (2022), the more than 68,800-square-foot distribution facility will be Avantor’s second in Dublin. The center will feature capabilities such as warehousing of cGMP certified products, batch-to-batch traceability, and customized palletization. Onsite clean rooms will also enable customers to conduct raw material sampling to expedite quality inspection and material receipt.
This is the latest in a series of recent investments by Avantor. In 2021, the company opened a new logistics hub in Westminster, Massachusetts, a single-use solutions facility in Hillegom, Netherlands, and completed capacity expansions for process ingredients, excipients, and single-use cleanrooms in multiple sites in Europe and the US. These investments are in addition to capabilities and capacity added through the acquisitions completed in 2021, including Ritter GmbH, RIM Bio, and Masterflex.