Avantor To Increase Single-Use Capacity; Sharp in $43-M ExpansionBy
The latest from CDMOs, CMOs, and suppliers featuring Avantor, Sharp, Cytiva, Vetter, Rentschler Biopharma, PPD, Catalent, Bushu Pharma, and others.
Chemical/Chemical API Manufacturing
Charnwood Molecular Secures Funding for Expansion
Charnwood Molecular, a Loughborough, UK-based a contract provider of chemistry services, process research and development, and custom synthesis, has secured additional capital from Synova, a Nyon, Switzerland-based private-equity firm, to fund expansions in 2021.
With the financing, Charnwood will become the sole occupier of a three-story laboratory facility at its campus in Loughborough, UK and will add additional members to its leadership team.
Source: Charnwood Molecular
Avantor To Increase Single-Use Capacity
Avantor, a supplier of ultra-high-purity materials for the life sciences and advanced technology industries, has announced that it will increase its global capacity for single-use technologies used in the production of biologics and vaccines.
In the US and Europe, the company will increase its single-use manufacturing footprint by 30% and double its cleanroom space. The investment will support demand for monoclonal antibodies (mAbs), cell and gene therapies, and vaccines, including those for COVID-19.
Avantor recently expanded its Morrisville, North Carolina single-use facility. By mid-year 2021, the company expects completion of a cleanroom expansion at its Devens, Massachusetts site and also expects to open its second European single-use facility in Hillegom, the Netherlands.
Vetter, Rentschler Biopharma Advance Strategic Alliance
Vetter, a CDMO of aseptic filling and packaging, and Rentschler Biopharma, a Laupheim, Germany-based biologics CDMO, have further enhanced their alliance to offer combined service offerings.
The collaboration was initiated in mid-2020 to bring combined capabilities in their service offerings. The collaboration uses Rentschler Biopharma’s experience in drug-substance manufacturing, including bioprocess development and active pharmaceutical ingredient production, and Vetter’s expertise in aseptic fill–finish and secondary packaging.
The companies have further strengthened the established framework for the alliance and set up a governance structure as well as implemented guidelines for their joint approach across departments, including quality, development services, logistics, and global business development. In parallel to starting their first joint client projects, they are also working closely on existing projects and related topics.
Cytiva To Provide Modular Biomfg Unit for AkesoBio Mfg Expansion
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in April 2020, is providing a modular biomanufacturing unit for AkesoBio, a China-based clinical-stage biopharmaceutical company. The 6 x 2,000-L space, the FlexFactory platform, will be used to further enhance the company’s biologics manufacturing capacity in China. Cytiva and AkesoBio are planning further builds to provide additional commercial manufacturing capacity in the years ahead (as reported on April 26, 2021).
Cytiva partnered with AkesoBio on its first FlexFactory platform in 2016 for clinical-scale manufacturing. Also in 2016, the companies established an antibody drug process development joint laboratory. In 2019, Cytiva partnered with AkesoBio to produce a 4 x 2,000-L FlexFactory platform for the commercial production of AkesoBio research drugs.
PPD To Expand GMP Lab in Ireland
PPD, a CRO, is expanding its Athlone, Ireland, GMP laboratory to increase the size of its current facility and is adding cell- and gene-therapy testing to the operation’s portfolio of services.
The Athlone GMP lab provides analytical services across all phases of pharmaceutical development and commercialization. The current 4,460-square meter operation will grow to 7,710 square meters upon completion of the project, which is expected to be fully functional by mid-2022 and is projected to create 180 new jobs over the next three years. The current operation employs nearly 300 scientists and project managers.
The expansion in Ireland allows PPD to provide the same services already available in the US through its Middleton, Wisconsin GMP lab. In addition to the lab in Athlone, PPD Laboratories includes GMP labs in Middleton, Wisconsin; bioanalytical labs in Middleton and Richmond, Virginia; central labs in Shanghai, China, Brussels, Belgium, Highland Heights, Kentucky, and Singapore; biomarker labs in Highland Heights and Richmond; a vaccine sciences lab in Richmond; and a multipurpose bioanalytical, biomarker, and vaccine sciences lab that is nearing completion in Suzhou, China.
Earlier this month (April 2021), Thermo Fischer Scientific agreed to acquire PPD for $17.4 billion plus the assumption of approximately $3.5 billion of net debt. The transaction, which is expected to be completed by the end of 2021, is subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals.
Forge Biologics Raises $120 M for Viral Vector Mfg Expansion
Forge Biologics, a Columbus, Ohio-based CDMO and developer of gene therapies, has raised $120 million from private investors to fund an expansion of its adeno-associated viruses (AAV) cGMP production capacity and fund its subsidiaries that are advancing AAV gene-therapy programs.
The company currently operates a 175,000-square-foot cGMP AAV viral vector manufacturing facility in Columbus, Ohio. Through its subsidiaries, Forge is also working to advance a proprietary pipeline of gene therapies, including its lead program (FBX-101) for treating Krabbe disease, an inherited disorder that destroys the protective coating (myelin) of nerve cells in the brain and throughout the nervous system.
Source: Forge Biologics
Sharp To Invest $43 M To Expand Ops in Pennsylvania
Sharp, a provider of contract packaging and clinical supply services, has announced an expansion of its operations at the company’s existing facilities in Allentown, Pennsylvania and Conshohocken, Pennsylvania and into a third facility in Macungie Borough, Lehigh County, Pennsylvania
The company plans to: (1) increase its manufacturing capacity by upgrading and partially re-purposing some of its four-facility Allentown campus; (2) upgrade and obtain new machinery and equipment for its two-facility Conshohocken site; and (3) carry out building improvements and obtain new machinery and equipment at its recently acquired 170,000-square-foot facility in Macungie Borough. The company is investing $42.9 million into the project.
This expansion will retain 1,092 current positions and create 335 new, full-time jobs over the next three years (as reported on April 14, 2021).
Catalent Forms Pact for Ultra-Low Temperature Freezers
Catalent has formed a partnership with Stirling Ultracold, an Athens, Ohio-based developer and manufacturer of ultra-low temperature (ULT) freezers for life-science and bio/pharmaceutical research, whereby Stirling Ultracold becomes the preferred provider of ULT storage across Catalent’s multiple business units to build Catalent’s cold-chain infrastructure for biologics and other temperature-sensitive materials.
The partnership with Stirling Ultracold has already seen the delivery and installation of over 200 freezers, with a further 60 planned, into Catalent’s clinical supply services and cell- and gene-therapy sites in the US, Europe, and Asia-Pacific.
Bushu Pharmaceuticals, Suzuken in Pact for Specialty Pharmaceuticals
Bushu Pharmaceuticals, a Saitama, Japan-based CMO, has entered into a business alliance agreement with Suzuken, a Nagoya, Japan-based pharmaceutical distributor, to offer a service supporting new product launches for specialty pharmaceutical manufacturers looking to enter the Japanese market.
The alliance will establish a one-stop logistics center in Soka City, Saitama Prefecture, Japan for manufacturing operations, general logistics, and other services for specialty pharmaceuticals, including marketing authorization holder/drug approval holder, consulting, import, inspection, manufacturing, storage (manufacturer logistics), wholesale distribution, post-marketing surveys, and patient support.
The collaboration will also establish a packaging center within Suzuken’s subsidiary, Chuo Unyu, under the Kazo Pharmaceutical Joint Logistics Center with Bushu Pharma starting contract manufacturing operations. Bushu Pharma will use the cold-storage area, spanning 1,465 square meters, to carry out contract manufacturing centered on secondary packaging such as inspection, labeling, and packaging.
Additionally, Bushu and Suzuken will initiate joint proposal business in the US for pharmaceutical manufacturers aiming to enter the Japanese market.
Source: Bushu Pharmaceuticals