Supplier News: Cambrex, Thermo Fisher, BioVectra & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Cambrex, Sumitomo Chemical, Thermo Fisher Scientific, VectorBuilder, BioVectra, Asahi Kasei, Delpharm, Evonik, Bora Pharmaceuticals, Aptar, Pharmira, Inke, and Akorn Bio.
Chemicals/Chemical API Manufacturing
Cambrex Completes $50-M US API Expansion
Cambrex has completed a $50-million expansion of its large-scale active pharmaceutical ingredient (API) manufacturing capabilities at its facility in Charles City, Iowa.
The start-up of the new manufacturing space is the culmination of a two-year project, originally announced in 2020, to increase the capacity of the facility by 30%.
Following the expansion, the facility has approximately 400 employees and an installed reactor capacity of over 25,000 gallons. The facility is located on a 45-acre property and produces APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.
In addition to its expansion in Iowa, Cambrex says it continues to invest in additional small- and mid-scale API manufacturing capacity at its facilities in Karlskoga, Sweden, and High Point, North Carolina. New capacity at those facilities is expected to come on line in late 2022 and mid-2023, respectively.
Sumitomo Chemical To Build API Mfg Facility
Sumitomo Chemical, a Tokyo, Japan-based chemicals company, has announced plans to construct a new manufacturing plant for active pharmaceutical ingredients (APIs) and intermediates for small-molecule drugs at its site in Oita City, Oita Prefecture, Japan.
The new plant is scheduled to come on stream in September 2024 and will be the company’s third API manufacturing facility. The company currently produces small-molecule drug APIs and intermediates at its plant in Anpachi-Cho, Gifu Prefecture, Japan, and at its plant in Kurashiki City, Okayama Prefecture, Japan.
In addition, Sumitomo began construction of a plant for drug substances for nucleic-acid drugs in Oita City in October 2021.
Source: Sumitomo Chemical
Shionogi Pharma, Fujimoto Chemicals, Five Others Launch API CDMO
Shionogi Pharma, the CDMO business of Shionogi Pharma, an Osaka, Japan-based bio/pharmaceutical company, and Fujimoto Chemicals Co., an Osaka, Japan-based manufacturer of active pharmaceutical ingredient (APIs), and intermediates, along with five other Japanese companies, have begun business of a new joint venture (JV) and CDMO of APIs and intermediates, Pharmira Co.
The companies established the JV in November 2021 and began the business on April 1, 2022.
Shionogi Pharma is the principal stakeholder with a 50.1% stake, and Fujimoto Chemicals holds a 10.0% stake. The other five companies in the JV are involved in facility construction and operations. The other companies and their stakes in the JV are: Chiyoda Corporation, a Kanagawa, Japan-based engineering and construction company (17.0% stake); Taisei Corporation, a Tokyo-based an engineering and construction company (15.9% stake); Takenaka Corporation, an Osaka, Japan-based general contractor (5.3% stake); Yokogawa Electric, a Tokyo, based provider of advanced technologies and products for measurement, control, and information support (1.1% stake); and Nagase & Co., a Tokyo-based importer/exporter of chemical products (0.7% stake).
The CDMO JV will use both batch and continuous manufacturing and provide process development and manufacturing on a clinical and commercial scale. Upon its introduction, continuous manufacturing will be applied mainly to the reaction and crystallization processes.
Inke Investing $9.7 M in Inhalation API Mfg
Inke, a Barcelona, Spain-based manufacturer of inhalation active pharmaceutical ingredients (APIs), is investing EUR 9 million ($9.7 million) to increase production capacity for inhalation APIs.
The investment will allow Inke to triple production capacity and the micronization of inhalation APIs at its manufacturing plant in Castellbisbal, Barcelona, by 2024. The company expects that approximately 80% of this EUR 9-million ($9.7-million) investment will be deployed by the end of this year (2022).
VectorBuilder Investing $500 M for Gene-Therapy R&D, Mfg Facility
VectorBuilder, a provider of products and services for gene therapies, has started construction of a new R&D and manufacturing center in Guangzhou, China.
The campus will include a CDMO facility with 30 production suites, designed for manufacturing of plasmids, mRNA, adeno-associated viruses, lentiviruses, cell lines and other types of viral and non-viral vectors. It will also offer CRO services. Additionally, the campus house a research institute dedicated to developing new gene-delivery technologies.
Construction is expected to cost $500 million and will be split into two phases over the next four years (as reported on April 11, 2022). There will be approximately 100,000 m2 of floor space capable of housing over 2,000 staff members. This project is part of a global expansion by VectorBuilder, with additional R&D and manufacturing sites planned in the US, Europe and Japan.
Thermo Fisher Opens New Single-Use Component Mfg Site
Thermo Fisher Scientific has opened a new single-use technology manufacturing site in Ogden, Utah.
The Ogden site is a 55,000-square-foot facility that will manufacture bioprocess container systems used for the delivery, processing, separation, storage, and transportation of liquids that are then used in bioprocessing. The $44-million facility is part of a $650-million multi-year investment that the announced last year (2021).
The Ogden site has hired more than 300 employees and has the potential to employ up to 450 at the facility in safety, quality, manufacturing, engineering, and warehousing. Overall, the company employs more than 2,000 people in Utah.
Source: Thermo Fisher Scientific
BioVectra Starts Construction on mRNA Mfg Facility
BioVectra, a Charlottetown, Prince Edward Island, Canada-based CDMO, has broken ground on a facility that will manufacture mRNA vaccines and therapeutics starting in 2023.
The new mRNA vaccine and biomanufacturing center will add 36,000 square feet to the company’s existing Charlottetown campus and, when operational, the facility will be able to produce 160 million doses of mRNA vaccine and fill–finish 70 million final vaccine doses per year for commercial distribution.
The $79.6-million expansion is facilitated by the Canadian government contributing $39.8 million through the Strategic Innovation Fund and a $10-million investment from the Province of Prince Edward Island.
The expansion also includes completing a single-use clinical scale microbial suite in Windsor, Nova Scotia, Canada, this summer (2022), as well as opening a research and development facility in Halifax, Nova Scotia. The addition to BioVectra’s Windsor site supports the development and production of plasmid DNA, the key ingredient to manufacture mRNA therapeutics and vaccines. BioVectra says it will also start to develop and manufacture nucleic acids and add additional capacity for advancing microbial protein and other biotherapeutics via microbial fermentation.
Asahi Kasei Medical To Acquire Bionova Scientific
Asahi Kasei Medical, a Tokyo, Japan-based medical care business, has agreed to acquire, through a US subsidiary, Bionova Scientific, a Fremont, California-based biologics CDMO. The acquisition complements Asahi Kasei’s bioprocess consumables and equipment and biosafety testing services business. Closing of the acquisition is subject to receipt of necessary regulatory clearances.
Source: Asahi Kasei
Akron Bio Expands with New pDNA Mfg Facility
Akron Bio, a Boca Raton, Florida-headquartered manufacturer and services provider to the regenerative medicine industry, has launched a new plasmid DNA (pNDA) manufacturing facility in Sarasota, Florida. As part of its expansion, the company says it will double its Sarasota workforce to more than 100 by the end of 2022.
Source: Akron Bio
Formulation Development/Drug-Product Manufacturing
Delpharm Investing $30 M in Prefilled Syringe Mfg Line
Delpharm, a CDMO of drug products, is investing EUR 28 million ($30 million) in a sterile manufacturing line for prefilled syringes at its plant in Tours, France.
Delpharm started the project in April 2021 to add a new building and will start manufacturing from the first quarter of 2023. The Tours facility will be able to produce between 25 million and 30 of millions syringes per year. The plant will provide glass, plastic, subcutaneous, intra-nasal and oro-mucosal prefilled syringes with formats from 1 mL to 50 mL. The investment will enable Delpharm to recruit an additional 20 to 40 people at its Tours site.
The company manufactures annually more than one billion units in its manufacturing sites (11 in France, two in Italy, two in Canada, one in Poland, and one in the Netherlands) and provides tablets, injectable vials and ampuls, freeze-dried products, suspensions, solutions, ointments, and soft gels.
Bora Pharmaceuticals To Expand Oral Solid Dose Capabilities
Bora Pharmaceuticals, a CDMO of drug products, plans to expand its oral solid dose capabilities across its facilities in Zhunan, Taiwan, and Mississauga, Ontario, Canada, with an investment of more than $10 million over the next two years (as reported on April 19, 2022).
Coinciding with the investment, Bora Mississauga has relaunched a pilot facility that was purpose-built for development and clinical manufacturing and is separate from its commercial manufacturing activities. The facility has 25 flexible rooms, which include misting showers and a separate air-handling unit to allow for clinical manufacturing of conventional and potent compounds at various batch sizes for oral solid dose as well as liquids, creams, and ointments. Bora has also acquired a Gerties MINI-PACTOR at its Mississauga site which will be operational in the second quarter of 2022.
In Zhunan, the company is set to commission a development/clinical area purpose built for containment. The space will allow Bora to handle high potent oral solid dose products categorized as OEB Level 4, < 0.01 mg/m3. A new blister line will also be added to complement the current tablet and capsule packaging capabilities on site. The Zhuhan facility’s construction is expected to begin in the second quarter of 2022, with operations planned for the first quarter of 2023.
Source: Bora Pharmaceuticals
Aptar Launches Activ-Vial System in China
Aptar CSP Technologies, part of the Aptar Group, is launching its Activ-Vial system in China. The Activ-Vial system is used for glucose-monitoring test strips. The Activ-Vial system will be produced at the company’s facility in Guangzhou, China
Aptar CSP Technologies’ Activ-Vial service features the company’s 3-Phase Activ-Polymer platform technology fully integrated into the vial to create a microclimate that protects against moisture and other environmental conditions that can impact diabetes test-strip stability.
Source: Aptar CSP Technologies
Evonik Realigns Healthcare Business
Evonik, a specialty and fine chemicals producer, has reorganized its healthcare business to streamline its operations into three new product lines: Drug Delivery & Product, Drug Substance, and Health Solutions, effective April 1, 2022 .
The Drug Delivery & Products unit, headed by Paul Spencer, Vice President Drug Delivery & Medical Device Solutions Product Line, focuses on advanced oral and parenteral drug delivery. This includes the company’s portfolio of excipients (e.g., Eudragit and Resomer), lipids, and lipid nanoparticles, with complementary CDMO services from feasibility studies to commercial drug products.
The new Drug Substance unit encompasses the company’s CDMO services for active pharmaceutical ingredients (APIs) and intermediates as well as its portfolio of API products. The new unit is led by Dr. Stefan Randl, Vice President Innovation Management Health Care. Since 2020, he has also been leading projects to advance Evonik’s position in mRNA and gene therapies.
The Health Solutions unit, under the leadership of Maximillian Yeh, Vice President, Health Solutions, brings together biopharma services, medical device services, and advanced food ingredients businesses.