Supplier News: MilliporeSigma, Curia, Lonza & More
The latest from CDMOs, CMOs, and suppliers featuring Curia, MilliporeSigma, Lonza, Avara Pharmaceutical Services, Scorpion Biological Services, Recipharm, Avantor, Matica Biotechnology, WuXi Advanced Therapies, Schott, and ICE Group. Highlights below.
Chemicals/Chemical API Manufacturing
* Curia Expands Small-Scale Mfg Capacity
* ICE Group Acquires Mfg Facility From Mitbubishi API
* MilliporeSigma Invests $110 M in Single-Use Mfg Facility
* Scorpion Biological To Build New $650-M Biomanufacturing Facility
* Matica Biotechnology Opens New Cell-, Gene-Therapy Mfg Facility
* WuXi Advanced Therapies Partners for Cell-, Gene Therapy Mfg Training
Formulation Development/Drug-Product Manufacturing
* Lonza To Sell Particle-Size Reduction Site
* Recipharm Expands Propellant Product Development for Inhalers
* Schott Investing To Expand Cartridge Production
* Avara Names New CEO
* Avantor Invests in Mfg, Distribution in Singapore
Chemicals/Chemical API Manufacturing
Curia Expands Small-Scale Mfg Capacity
Curia (formerly AMRI) has expanded its small-scale capacity at its chemical development site in Albany, New York, with the addition of two new suites to support orphan and accelerated products.
The additional suites follow the expansion of a kilo lab last year (2021), which enabled additional production of kilogram-scale quantities. The new suites have 200-L/100-L fixed reactor trains, which triples Curia’s Albany site’s 200-L capacity.
ICE Group Acquires Mfg Facility From Mitsubishi API
ICE Group, a Reggio Emilia, Italy-based manufacturer of ursodeoxycholic acid (UDCA) substances and other bile derivatives for hepatic disease treatments, has acquired an UDCA manufacturing site in Iwaki, Japan, from Mitsubishi API, a subsidiary of Mitsubishi Chemical Holdings Corporation.
Under the agreement, the facility and its employees will be integrated into ICE Group’s manufacturing network. This is the company’s fourth UDCA manufacturing facility in Asia.
Source: ICE Group
MilliporeSigma To Invest $110 M in Single-Use Mfg Facility
MilliporeSigma, the life-sciences arm of Merck KGaA, plans to invest a total of EUR 100 million ($110 million) over six years to expand its single-use manufacturing center in Wuxi, China.
The investment will enable the company to expand the existing Wuxi production site to increase biopharma single-use assemblies and custom design capabilities. MilliporeSigma signed an agreement with the Administrative Management Committee of Wuxi National High-Tech Industrial Development Zone for the expansion.
Scorpion Biological Plans New $650-M Biomanufacturing Facility
Scorpion Biological Services, a San Antonio, Texas-based CDMO focused on cell- and gene-based therapies and large molecules, plans to invest $650 million to build a new biodefense-focused biomanufacturing facility in Manhattan, Kansas.
The $650-million commercial-scale facility will have approximately 144,000 liters of biomanufacturing capacity across 48 bioreactors.
The majority of the facility will be dedicated to commercial CDMO services, but the company is exploring the design of trains focused on other products for the US government’s strategic national stockpile. Where possible, Scorpion plans to use a US-based supply chain, beginning with the decision to install Pall bioreactors.
Scorpion intends to start manufacturing Anthim, an antitoxin against anthrax, by mid-2024. The company is planning a phased building approach to complete the production train for Anthim by April 2024, with plans to complete a new train every 15 months thereafter. Scorpion projects that the Manhattan facility will be complete, fully functional, and staffed by April 2027.
Source: Scorpion Biological Services
Matica Biotechnology Opens New Cell, Gene Therapy Mfg Facility
Matica Biotechnology, a recently launched CDMO of CHA Biotech, a South Korea-based biopharmaceutical company, has opened a new 45,000-square-foot facility in Texas dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines.
The company is working with two partners at the new facility. Matica Biotechnology is working with Sartorius to develop and optimize advanced viral vector manufacturing technologies for large-scale vector production. The company has also partnered with Texas A&M University’s Center for Innovation in Advanced Development and Manufacturing for projects to speed up R&D and commercial manufacturing.
Source: Matica Biotechnology
WuXi Advanced Therapies Partners for Cell-, Gene Therapy Mfg Training
WuXi Advanced Therapies, (WuXi ATU), a CDMO for advanced therapies, and Singapore’s Agency for Science, Technology and Research’s Bioprocessing Technology Institute (BTI), have entered into a partnership to provide training for cell- and gene-therapy manufacturing in the Asia-Pacific region.
WuXi ATU is providing its Tetracycline-Enabled Self-Silencing Adenovirus (TESSA) technology, a process for scalable manufacture of adeno-associated viruses. WuXi ATU will supply the materials, equipment, funding, and training required to further develop and commercialize TESSA technology in Singapore. BTI will contribute research expertise, facilities, and access to its network of partners to support WuXi ATU.
Source: WuXi AppTec
Formulation Development/Drug-Product Manufacturing
Lonza To Sell Particle-Size Reduction Site
Lonza has agreed to sell its particle-size reduction site in Quakertown, Pennsylvania, to an undisclosed group of investors.
The Quakertown site employs approximately 45 employees and focuses on particle-size reduction and control services for drug substances and excipients. The site consists of two individual buildings and supporting infrastructure, including nine cGMP suites, two developmental suites, and phase-appropriate equipment for particle-size reduction from early development through to commercial supply. Upon closing, the Quakertown business will become an independent company called Microsize.
The agreement, expected to close in the summer of 2022, is subject to relevant closing conditions. Lonza will continue to provide micronization and jet milling services from its site in Monteggio, Switzerland site.
Recipharm Expands Propellant Product Development for Inhalers
Recipharm is expanding its pressurized metered-dose inhaler (pMDI) product development services by investing in new manufacturing lines to support introducing more sustainable propellants to its pMDI production.
The expansion of pMDI product development services complements Recipharm’s existing capability to offer pMDI valves suitable for new propellants. As a result, Recipharm can offer valve selection and product reformulation to enable pharmaceutical companies to transition their pMDI products.
Recipharm’s in-house product development expertise will be complemented by a collaboration with Professor Darragh Murnane and his research group at the University of Hertfordshire in the UK to develop tools, techniques, and transition pathways. Recipharm’s device-development team recently completed a three-year Innovate UK Knowledge Transfer Partnership research program with the University of Hertfordshire and the University of East London. The program developed device modelling toolkits to accelerate and tailor device design to pMDI aerosol product performance needs.
Schott Investing To Expand Cartridge Production
Schott, a specialty glass and materials company, is investing to expand its production capacity for ready-to-use cartridges at its site in St. Gallen, Switzerland. The expansion will include cleanroom infrastructure, including washing line equipment, and is scheduled for completion in 2023.
The capacity expansion is designed for new manufacturing with a glass-to-glass process contact-free process, which aims at eliminating possible scratches or other glass defects.
Avara Names New CEO
Avara Pharmaceutical Services, a Norman, Oklahoma-based CDMO, has named Joe Principe, formerly Vice President of Strategic Partnerships at Patheon, Thermo Fisher Scientific, as CEO.
As CEO, Mr. Principe will be responsible for all aspects of executive management of Avara’s global business. Mr. Principe brings more than 20 years of experience in marketing, financial analysis, and negotiation to the Avara organization.
Larry Lee, who has served as CEO since November of 2019, will be transitioning to a new role as Chief Operations Officer (COO). As COO, Mr. Lee will be responsible for managing all aspects of the operational and administrative functions for Avara.
Additionally, Anup Gupta, has joined Avara as Chief Financial Officer (CFO); he has over 30 years of global experience in finance, strategy, M&A, and operations in both public and private companies.
Source: Avara Pharmaceutical Services
Avantor Invests in Mfg, Distribution in Singapore
Avantor, a supplier of ultra-high-purity materials for the life sciences and advanced technology industries, is investing in a new manufacturing and distribution hub in Singapore, which will integrate its existing distribution facility with new manufacturing operations.
The new hub will provide a range of services, including quality control and inventory management expertise, and feature manufacturing suites and testing labs for process ingredients and excipients.