Supplier Roundup: Catalent, Flamma, Avantor, Aenova, Olon, and More
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Flamma, Avantor, Aenova, Olon, Phlow, Charles River Laboratories, Tjoapack, Swissfillon, and others.
Chemicals/Chemical API Manufacturing
Olon Expands Biocatalysis Capabilities, HPAPI Mfg
Olon has announced a new international network for large-scale biocatalysis and plans to expand manufacturing capacity for high-potency active pharmaceutical ingredients (HPAPIs).
The Olon Group has created an international network to launch large-scale biocatalysis as an industrial technology within its production facilities in Italy and globally. The partnership combines the Olon Group, Biosphere, an Italian company specialized in fermentation and industrial biotechnology, and the Biocatalysis Group of the Van’t Hoff Institute for Molecular Sciences (HIMS-Biocat) at the University of Amsterdam.
Olon has also announced plans to invest in a new production line for HPAPIs at Olon Ricerca Bioscience, its campus located in Ohio. The company say over the long term, the plan is to increase its capacity and allow the US site to mirror the capacity of its Italian facilities, including multiple sites that can perform the production of HPAPIs on a larger scale.
Flamma Announces Updates to US, China, Italy Sites
Flamma Group, a contract development and manufacturing organization for small-molecule active pharmaceutical ingredients (APIs), has announced updates to its sites in the US, China, and Italy.
Flamma USA, part of the Flamma Group, has completed the re-commissioning of its high-potency active pharmaceutical ingredient (HPAPI) suite.
Additionally, the Flamma Honkai site in Dalian, China has passed its final inspection by the Chinese National Medical Products Administration. Flamma says it is looking to expand its footprint within China and will be moving toward another workshop in the Songmudao Chemical Park in the province of Liaoning.
In Italy, construction of the company’s new R&D building is nearing completion. Flamma says it will begin transitioning from the current R&D building into its new R&D building in the second quarter of 2022 and be fully moved in by early the third quarter of 2022.
Phlow Included in US Gov’t CDMO Network
Phlow Corporation, a Richmond, Virginia-based pharmaceutical manufacturing company, has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA) CDMO network to provide domestic active pharmaceutical ingredients (API) capability for essential medicines and medical countermeasures.
The network is part of an effort by the US government to provide a domestically integrated, systematic approach to the development of vaccines, drugs, therapies, and diagnostic tools needed to address public health emergencies.
BARDA is part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. BARDA’s CDMO network includes manufacturers that are prequalified and ready to deliver medicines.
Source: Phlow Corporation
Catalent’s Investing $230 M To Expand Gene-Therapy Mfg
Catalent has announced a $230-million expansion project to add three commercial-scale viral-vector manufacturing suites and associated support facilities and services at its gene-therapy campus in Harmans, Maryland, which brings its total investment at the site to $360 million.
A second facility is under construction following an initial $130 million investment by Catalent in 2020, which will add five new manufacturing suites that are expected to be operational mid-2022. This latest investment will include the construction of three additional multi-room commercial suites, as well as expanding the site’s storage capabilities for inventory space, ultra-low temperature freezers, and water-for-injection infrastructure.
When completed at the end of 2022, the campus will house a total of 18 viral-vector manufacturing suites, each designed to accommodate multiple bioreactors up to 2,000-liter scale and enable the execution of commercial manufacturing from cell bank to purified drug substance.
Avantor Opens New Single-Use Mfg Facility
Avantor, a supplier of ultra-high-purity materials for the life sciences and advanced technology industries, has opened a new single-use facility in Hillegom, the Netherlands.
The site is Avantor’s second single-use location in Europe after its Tilburg, the Netherlands site and is an addition to the company’s overall cleanroom capacity in the region. The Hillegom facility enables Avantor to manufacture, package, and deliver single-use solutions that support all stages of biologics manufacturing, including upstream, downstream and fill-finish.
GTP Bioways Expanding Biomanufacturing
GTP Bioways, a Toulouse, France-based CDMO specializing in the production of biotherapies and nanotherapies, is investing EUR 12 million ($14 million) for two new bio/pharmaceutical production lines at its site in Toulouse.
The first line will be dedicated to production using microbial systems. With a capacity of 300 L, the production line will be operational in the first quarter of 2023. The second pharmaceutical manufacturing unit is designed for mammalian-cell culture biomanufacturing at a scale of 10 L for small batches of proteins and antibodies. From the fourth quarter of 2022, the unit will be able to manufacture biomolecules for vaccines and raw materials for pharmaceutical use for the production of cell therapies.
The company also plans to increase its staff from 45 in 2021 to nearly 100 in 2025.
Source: GTP Bioways
Bionova Opens Biologics Mfg Facility
Bionova Scientific, a Fremont, California-based biologics CDMO, has opened a new biologics manufacturing center at its Fremont, California, headquarters. The first clinical supply run at the facility is slated to be completed before year-end 2021.
Formulation Development/Drug-Product Manufacturing
Aenova Expands Sterile Fill-Finish Capacity
Aenova, a Starnberg, Bavaria-based CDMO of sterling manufacturing, has expanded its sterile fill–finish capacity at its site in Latina, Italy.
The new aseptic production area features a high-speed flexible line for vials and prefilled syringes as well as a compounding area. This area provides capacity for more than 80 million vials and over 180 million prefilled syringes, targeting vaccines and biologics. Further capacity expansions to a total of up to four high-speed filling lines are also being planned.
ten23 health Acquires Swissfillon
ten23 health, a new Basel, Switzerland-based CDMO of injectable drugs launched by 3i Group, a London-based investment group, has acquired Swissfillon, a Visp, Switzerland-based drug-product CDMO specializing in sterile filling.
The combined business of ten23 health and Swissfillon will provide sterile drug-product development and manufacturing. Swissfillon will continue to operate under its brand. Prof. Dr. Hanns-Christian Mahler will serve as CEO of the combined entities under the ten23 health umbrella.
Renaissance Lakewood in $40-M Expansion
Renaissance Lakewood, a Lakewood, New Jersey-based CDMO, has announced a $40-million investment to expand its now 370,000-square-foot main campus.
The facilities upgrade began in 2020 and consists of two new buildings as well as the renovation of the company’s headquarters building in Lakewood. A multi-million-dollar investment in technology and equipment is also part of the modernized structures.
The new campus has a 31,000-square-foot Science Building that will serve as the future home to all of Renaissance’s R&D and quality assurance labs and will include a spray lab.
The company says the 81,000-square-foot campus will increase Renaissance’s warehouse square footage as well as serve as the primary client engagement and administrative hub for the company. The building is expected to be ready for occupancy in the first quarter of 2022.
Source: Renaissance Lakewood
Tjoapack Acquires Pharma Packaging Solutions
Tjoapack, a North Brabant, Netherlands-based contract packaging organization, has acquired Pharma Packaging Solutions (PPS), a Clinton, Tennessee-based healthcare packaging services business.
PPS provides commercial packaging and other complementary services such as cold-chain storage, stability, and product-retain services to the pharmaceutical and medical device industry.
Tjoapack’s acquisition of PPS was funded by Ampersand Capital Partners, which first invested in the company in 2020. With support from Ampersand, Tjoapack is nearing the completion of a facility expansion to increase packaging capacity for both oral solid and parenteral-drug products.
Charles River To Expand Bio/Pharma Development Lab
Charles River Laboratories, a Wilmington, Massachusetts-headquartered contract research organization, has announced plans to expand its Charles River Accelerator and Development Lab (CRADL) in Cambridge, Massachusetts, and add a second Cambridge location.
CRADL’s flagship location opened in 2018 with 15,000 square feet. The latest addition has increased square footage to 45,000 square feet. Additionally, Charles River has begun the process of opening a second CRADL location in Cambridge by adding an additional 18,000 square feet of capacity, with the first phase planned to open in late 2021.
Source: Charles River Laboratories