BD, Fareva To Expand; WuXi Launches Bioconjugates JVBy
The latest from CDMOs, CMOs, and suppliers featuring BD, Fareva, WuXi AppTec, Aceto, Thermo Fisher Scientific, Lonza, Aragen Life Sciences, Colorcon, Univercells, PerkinElmer, and others.
Chemicals/Chemical API Manufacturing
Aceto Acquires Majority Stake in Finar
Aceto, a provider of specialty materials for life sciences and advanced technology end markets, has acquired a majority stake in Finar Limited, an Ahmedabad, India-based manufacturer, supplier, and distributor of pharmaceutical excipients, lab chemicals, aquaculture inputs, and food-grade additives.
Finar manufactures pharma ingredients, including GMP-/pharma-grade solvents, advanced intermediates, and GMP excipients used in both small- and large-molecule applications. Finar also provides regulatory and documentation support, including drug master filing and has an R&D team with expertise in developing specialized excipients for complex formulations.
Aceto will continue to support Finar’s manufacturing facilities and offices in India.
WuXi Biologics, WuXi STA Launch Bioconjugates JV
WuXi Biologics, a contract biologics manufacturer, and WuXi STA, a subsidiary of WuXi AppTec, have established a joint venture company named WuXi XDC to provide end-to-end contract development and manufacturing of bioconjugates, including antibody-drug conjugates (ADCs).
Under the joint-venture agreement, WuXi Biologics and WuXi STA will make capital contributions of $120 million and $80 million, respectively. WuXi Biologics will have 60% stake and WuXi STA 40% stake in WuXi XDC. WuXi XDC will become a non-wholly owned subsidiary of WuXi Biologics, providing services for development and manufacturing of antibodies or other biologics, chemical payloads and linkers, and the bioconjugated drug substance and drug product.
Dr. Jimmy (Jincai) Li was appointed as CEO of WuXi XDC. Dr. Li has been with WuXi Biologics since 2011 and has led various functions, including the establishment of cell-culture process development operations and the pilot-plant production group as well as facility management. He has 20 years of experience in biologics process development, scale-up and manufacturing at Diversa Corporation (now part of BASF), Tanox and Roche’s Genentech.
Source: WuXi Biologics and WuXi STA
Thermo Fisher, University of California To Open Cell-Therapy Mfg Center
Thermo Fisher Scientific and the University of California, San Francisco (UCSF) have formed a strategic alliance to accelerate the development and manufacturing of cell-based therapies by opening a cell-therapy manufacturing and collaboration center.
Under the agreement, Thermo Fisher will build and operate a 44,000-square-foot cell-therapy development, manufacturing, and collaboration center in leased space on UCSF’s Mission Bay campus, which includes biomedical research facilities and hospitals. The site will offer clinical and commercial cGMP cell-therapy manufacturing services, along with associated technology development support, to UCSF and other partners.
Expected to open in 2022, the facility will also serve as a central location where customers and UCSF researchers will have access to Thermo Fisher’s portfolio of cell-therapy systems reagents, consumables, and fit-for-purpose instrumentation and compliant software.
Source: Thermo Fisher Scientific and the University of California, San Francisco
Lonza Launches 4D-Cell Transfection Platform
Lonza has launched the next generation of its Nucleofector Platform, a non-viral cell transfection method for a wide variety of cell types.
The 4D-Nucleofector Platform has an updated core unit and more intuitive software. Its modular design offers flexibility in scale. The unit can operate up to three functional modules, to allowing for tailored experimental setups and facilitating scale-up from low to high-volume transfection.
Univercells, NIBRT in Pact for Viral Product Mfg Training
Univercells Technologies, a technology company specializing in bioprocessing, and the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin, Ireland, are collaborating to address the need for training in viral products manufacturing for cell and gene therapies.
Univercells’ Scale-X Carbo system will be featured at the Dublin facility for bio/pharma industry researchers and personnel to gain hands-on experience with this system and biomanufacturing technologies.
NIBRT will use the Scale-X Carbo bioreactor for dedicated cell culture and viral manufacturing training courses for academia and industry experts starting in the third quarter of 2021.
Source: Univercells and National Institute of Bioprocessing Research
CDMO Gamma Biosciences Acquires Stake in Mirus Bio
Gamma Biosciences, a life sciences company for advanced therapies, has agreed to make a controlling investment in Mirus Bio, a Madison, Wisconsin-based company of biomimetic, cell-adaptive lipid-polymer nanocomplexes (LPNCs) for nucleic acid delivery.
The transaction will support Mirus’ plans to expand GMP production and commercialization of its product, TransIT VirusGEN, for large-scale manufacturing of adeno associated virus (AAV) and LV-based viral vectors for gene therapy, as well as further development and commercialization of the platform for in vivo delivery applications.
Mirus will use Gamma Bio’s strategic and commercial resources and will work closely with its other operating companies, including Univercells Technologies, Astrea Bioseparations, Nanopareil and Biomagnetic Solutions.
Current Mirus shareholders will retain an equity ownership stake in the company.
Source: Gamma Biosciences
Matica Biotechnology Names New CEO
Matica Biotechnology, a recently launched CDMO of CHA Biotech, a South Korea-based biopharmaceutical company, has appointed Yun Jeong Song, MD, as the company’s new Chief Executive Officer (CEO) to continue its expansion as a CDMO.
Dr. Song joined the company effective in April 2021 after three years as CEO of ImmuneOncia Therapeutics, an international joint venture developing immuno-oncology therapies. Dr. Song succeeds Byung Se So, PhD, who will remain with Matica Biotechnology as an advisor.
Dr. Song has more than 20 years of experience in basic research, patient care, and bio/pharmaceutical industry leadership. Prior to ImmuneOncia Therapeutics, she held positions at the US National Institutes of Health, Samsung, and Sanofi.
Source: Matica Biotech
Formulation Development/Drug-Product Manufacturing
Fareva Invests $30 M to Expand High-Potent Drug-Product Mfg
Fareva has invested €25 million ($30 million) to increase its capacity for high-potent drug-product manufacturing.
The investment will expand the company’s high-potent tablets and capsules operations, which will be available for production in 2023. The production facilities will be expanded this year (2021) with a new 2,850-square-meter building to reach capacity of 500 million units of tablets or capsules, up to OEB6 containment level. An additional suite for future demand is also a part of the program.
The expansion program started in 2016 at the company’s site in Fareva La Vallée, France. Increasing capacity for highly potent APIs was added, with a pilot plant, a production building and additional R&D laboratories. In 2018/2019, Fareva’s Excella site in Feucht, Germany expanded its analytical capabilities and added roller compaction for highly potent drug products.
In April 2021, the company completed the acquisition of a Novartis’ site in Unterach, Austria, which specializes in injectable, high-potent drug products, with packaging available in vials and pre-filled syringes.
Colorcon Adds Containment Suite
Colorcon, a developer of film-coating systems and excipients, has expanded its technical service capabilities with the addition of a new containment suite to handle high-potency active pharmaceutical ingredients (HPAPIs) at its global headquarters in Harleysville, Pennsylvania.
The containment suite provides the capability to develop prototype tablet or capsule dosage forms for clients when active pharmaceutical ingredient (API) quantity is limited and/or the API potency requires a higher level of protection. The lab uses mobile isolation modules for maximum process flexibility.
BD To Invest $201 M for New Drug-Delivery Devices Facility
Becton, Dickinson and Company (BD), a Franklin Lakes, New Jersey-based medical technology company, plans to build an EUR 165-million ($201-million) manufacturing facility for drug-delivery devices in Zaragoza, Spain.
BD plans to begin construction of the new plant in late 2021, and the new facility will be the fourth manufacturing plant for BD in Spain. The site will initially have a workforce of 150 people and encompass an area of 8,000 square meters. By 2030, the site is expected to employ up to 600 people with an area of 30,000 square meters (323,000 square feet).
The new site represents a portion of the $1.2-billion investment over four years that was the company announced in December 2020 to expand and upgrade manufacturing capacity and technology for pre-fillable syringes and advanced drug-delivery systems as part of BD’s 2025 growth strategy. The new site also continues BD’s commitment to Spain, where it started operations more than 40 years ago and currently has three production plants located in San Agustín de Guadalix, Fraga, and Almaraz. These facilities produce a total of 10 billion medical devices each year and employ 1,500 people. The Fraga plant is a key production site for the manufacture of COVID-19 vaccination injection devices.
Source: Becton, Dickinson and Company
Goldman Sach Invests in CRO Aragen Life Sciences
Aragen Life Sciences, formerly known as GVK Biosciences and a contract research organization (CRO), reports that Goldman Sachs has taken a minority stake in the company by acquiring shares previously held by ChrysCapital and other existing shareholders.
Aragen is a provider of outsourced discovery, development, and manufacturing services across both large- and small-molecule platforms and serves a worldwide customer base that includes the US, Europe, and Japan. The company has seven sites in India and overseas. It has more than 3,000 employees and serves more than 450 life-sciences customers across biotech and large cap-companies.
Aragen Life Sciences officially launched its new identify as Aragen Life Sciences in May 2021 to reflect the combined businesses of Aragen Bioscience, a Morgan Hill, California-based CRO focused on preclinical biologics product development and a wholly owned subsidiary of GVK BIO, a CRO headquartered in Hyderabad, India.
Source: Aragen Life Sciences
PerkinElmer Makes $405 M in Combined Acquisitions
PerkinElmer has announced plans to expand with a combined $405-million in company acquisitions.
PerkinElmer has agreed to acquire Nexcelom Bioscience, a Lawrence, Massachusetts-based developer and marketer of image cytometry products for cell analysis in life-science research and drug discovery, development and manufacturing, for $260 million. The transaction is expected to close during the second quarter of 2021.
Nexcelom has approximately 130 employees with expected 2021 revenues are approximately $40 Million.
PerkinElmer has also agreed to acquire Immunodiagnostic Systems (IDS), an in-vitro diagnostics company, for approximately $155 million. The transaction has a total enterprise value of approximately $124 million and is expected to close early in the third quarter of 2021.
Through this acquisition, PerkinElmer will be able to grow its overall diagnostics business, specifically its immunodiagnostics segment. Moreover, the deal will enable PerkinElmer to combine its expertise and testing capabilities with IDS’s chemiluminescence products in endocrinology, autoimmunity, and infectious diseases.
Source: PerkinElmer (Nexcelom), PerkinElmer (Immunodiagnostic Systems), and Nexcelom