Supplier News: Axplora, MilliporeSigma, Cytiva & More
The latest from CDMOs, CMOs, and suppliers featuring MilliporeSigma, Cytiva, Fujifilm Diosynth Biotechnologies, Kindeva Drug Delivery, Meridian Medical Technologies, WuXi Vaccines and Axplora.
Chemicals/Chemical API Manufacturing
* Novasep-PharmaZell Renamed as Axplora
Biologics Manufacturing
* Cytiva Opens Cell-Culture Center of Excellence
* Fujifilm Diosynth, NC State University Expand Biomanufacturing Pact
Formulation Development/Drug Product Manufacturing
* Kindeva, Meridian Medical To Merge to Form Drug–Device CDMO
* WuXi Vaccines To Acquire Mfg Facility From Harbour BioMed
General
* MilliporeSigma Investing $286 M To Expand Biosafety Testing Capacity
Chemicals/Chemical API Manufacturing
Novasep-PharmaZell Renamed as Axplora
Novasep-PharmaZell, a CDMO of small-molecule active pharmaceuticals ingredients (APIs), intermediates, and antibody drug conjugates (ADCs), has re-branded as Axplora. Novasep-PharmaZell was formed from the April 2022 merger of Novasep, a Lyon, France-based CDMO of APIs and ADCs, and PharmaZell, a Raubling, Germany-based CDMO of small-molecule APIs. The combined company also includes Farmabios, part of PharmaZell, a Gropello Cairoli, Pavia, Italy-based manufacturer of non-sterile and sterile steroids and a CDMO of APIs and intermediates, including high-potency APIs.
The combined company has a footprint in Europe, the US, and India with 11 production and R&D sites: eight in Europe (France, Germany, and Italy), two in India, and one in the US.
Source: Axplora
Biologics Manufacturing
Cytiva Opens Cell-Culture Center of Excellence in US; Expands
Cytiva has opened a 11,500-ft2 cell-culture Center of Excellence at its site in Marlborough, Massachusetts, to provide expanded cell-culture media development capabilities and new cell- line development services. Separately, the company is investing $8 million to expand its biotech center in Shanghai.
The Shanghai center will cover 11,000 m2 and will provide the following: (1) biotech training for up to 2,000 people a year, including training in digitalization, automation and continuous-flow manufacturing; (2) expand the company’s existing biomolecule R&D and GMP pilot manufacturing platform; (3) be home to the Cytiva China Online Center, which is dedicated to remote and intelligent customer services with technologies, such as augmented reality and the Internet of things; (4) house Cytiva’s first single-use technology Center of Excellence in Asia, which will provide new product R&D tests and validation with the ability to hold 350 projects annually; and (5) provide demonstration services of continuous manufacturing for monoclonal antibody-based drugs.
Source: Cytiva (Center of Excellence) and Cytiva (Shanghai Center)
Fujifilm Diosynth, NC State University Expand Biomanufacturing Pact
Fujifilm Diosynth Biotechnologies, a biologics CDMO, and North Carolina State University (NC State) have expanded their biomanufacturing pact to include new research projects, sustainable facility design, and development of bioprocessing advancements at the company’s future $2-billion cell-culture biomanufacturing site in Holly Springs, North Carolina. The site is set to open in 2025.
The partnership will focus on research and facility design to support Fujifilm’s goal to achieve net-zero carbon emissions by 2030 at the Holly Springs site. NC State is collaborating with the company on sustainable site development plans to achieve carbon neutrality. The future site design targets 100% clean energy utilization, implementation of advanced waste disposal and recycling and other sustainability plans. NC State’s College of Design researchers are conducting an ecosystem services assessment to set and monitor environmental performance targets.
Additionally, the partnership will focus on the development of new bioprocessing development techniques using machine learning, artificial intelligence, and analytical methods.
The first project under the new agreement is expected to begin by the end of 2022.
Source: Fujifilm Diosynth Biotechnologies
Formulation Development/Drug Product Manufacturing
Kindeva, Meridian Medical To Merge to Form Drug-Device CDMO
Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, and Meridian Medical Technologies, a Saint Louis, Michigan-based CDMO of autoinjectors, have agreed to merge to form a drug–device combination product CDMO.
The combined company will have a range of drug-delivery capabilities, including for parenteral, inhalation, transdermal, and intradermal routes of administration. Milton Boyer, current CEO of Meridian, will be CEO of the newly combined company.
Kindeva and Meridian are operating companies of Altaris, a healthcare investment firm. Kindeva was acquired by Altaris in 2020 from 3M Company, and Meridian was acquired by Altaris in December 2021 from Pfizer.
Kindeva and Meridian will continue to operate independently until closing.
Source: Kindeva Drug Delivery
WuXi Vaccines To Acquire Mfg Facility From Harbour BioMed
WuXi Vaccines, a Wuxi, China-based CDMO of vaccines, has agreed to acquire a manufacturing facility in Suzhou, China, from Harbour BioMed, a Cambridge, Massachusetts-based bio/pharmaceutical company. WuXi Vaccines is joint venture between WuXi Biologics, a biologics CDMO, and Hile Bio-Technology, a Shanghai-based animal health company.
The 8,500-m2 facility includes multiple 250-L, 500-L and 1,000-L single-use bioreactors as well as sterile drug-product manufacturing lines. WuXi Vaccines will renovate the facility to become WuXi Vaccines’ first stand-alone vaccine development and GMP manufacturing site in China.
Source: WuXi Vaccines
General
MilliporeSigma Investing $286 M To Expand Biosafety Testing Capacity
MilliporeSigma, the life-science business of Merck KGaA, is investing more than $286 million to expand biosafety testing capacity at the company’s site in Rockville, Maryland.
The 250,000-square-foot facility in Rockville will house biosafety testing, analytical development, viral clearance suites, and cell-bank manufacturing services. Currently, about 600 employees work at the site (as reported on November 16, 2022), and over the next four years, the expansion will create more than 500 new jobs.
Source: MilliporeSigma
