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MolMed S.p.A Becomes AGC Biologics S.p.A Following the July Acquisition

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AGC Biologics Now Provides End-to-End Cell and Gene Therapy CDMO Services


(SEATTLE), October 27, 2020 -- After its parent company AGC Inc. acquired 100% of the shares of MolMed S.p.A. on September 30, 2020, AGC Biologics announced that MolMed’s entity name has been changed to AGC Biologics S.p.A. This Center of Excellence for AGC Biologics’ cell and gene therapy Contract Development and Manufacturing Organization (CDMO) services is in Milan, Italy. The Milan site was the first GMP facility approved in Europe for ex-vivo gene therapy manufacturing and has unique commercial manufacturing experience, with two cell & gene therapy products. AGC Biologics is now one of the very few CDMO’s in the world offering both plasmid production and end-to-end cell and gene therapy services.

AGC Biologics Shifts Leadership Structure at United States and Copenhagen Sites to Support the Continued Development and Growth of the Regions

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(SEATTLE, WA), October 15, 2020 – AGC Biologics, a leading global biopharmaceutical contract development and manufacturing organization (CDMO), has announced a leadership update at the United States and Copenhagen facilities. The changes are being made to strengthen the strategic development and executive oversight of the rapid growing facilities in the US and Copenhagen, and are effective at the date of release, October 15, 2020.

AGC Biologics Appoints Luca Alberici as the New General Manager/Site Head of the Milan, Italy Site

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(SEATTLE, WA), October 12, 2020 – AGC Biologics, a leading global biopharmaceutical contract development and manufacturing organization (CDMO), has announced a new appointment to initiate integration efforts resulting from the July 31, 2020 acquisition of MolMed, a biotechnology company focused on research, development, production and clinical validation of cell and gene therapies for the treatment of cancer and rare diseases. Effective immediately, Luca Alberici will transition from Chief Business Officer of MolMed to take on the role of General Manager/Site Head at the Milan, Italy site.

AGC Biologics Completes PPQ Manufacturing Campaign with Provention Bio for Type 1 Diabetes Product Candidate, Teplizumab

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(SEATTLE), August 25, 2020 -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), achieved the on-schedule completion of a drug substance Process Performance Qualification (PPQ) campaign, focused on teplizumab (PRV-031) for partner Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases. The PPQ campaign consisted of three commercial scale runs required for the validation of Provention Bio’s drug substance manufacturing process and the demonstration of its ability to manufacture consistently, batch-to-batch, at commercial scale.

AGC Biologics Enters into Partnership as a CDMO with Ono Pharmaceuticals to Manufacture Biopharmaceuticals at Clinical Development Stage

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(SEATTLE), August 13, 2020 – AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it is partnering with Ono Pharmaceutical Co., Ltd. (ONO) to manufacture new, innovative biopharmaceuticals at the clinical development stage. ONO is a R&D-oriented pharmaceutical company committed to discovering and developing innovative drugs.

AGC Biologics Expands Partnership with Novavax

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Manufacturing of Novavax’ Matrix-M™ Adjuvant for Novel COVID-19 Vaccine Expands to Seattle

(SEATTLE), August 10, 2020 -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it has expanded its partnership with Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. AGC Biologics is currently preparing to manufacture Matrix-M™, the adjuvant component of Novavax’ coronavirus vaccine, NVX-CoV2373, from its facility in Copenhagen. AGC Biologics will now expand supply of Matrix-M adjuvant for the vaccine from its facility in Seattle to ensure supply for the United States.

AGC to Complete the Acquisition of MolMed on July 31, 2020

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AGC Biologics adds leading-edge cell & gene therapy company in Milan, Italy

(SEATTLE), July 27, 2020 -- AGC Biologics, a Global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that they will acquire the majority of the share capital of Molecular Medicine S.p.A. ("MolMed") on July 31, 2020. MolMed is a biotechnology company focused on research, development, production and clinical validation of cell and gene therapies for the treatment of cancer and rare diseases. AGC Biologics is now one of the very few CDMO’s in the world offering both plasmid production and end-to-end cell and gene therapy services.


AGC Biologics Collaborates with Molecular Partners AG to Develop Anti-COVID-19 DARPin® Program

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(SEATTLE), July 9, 2020 -- Global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) AGC Biologics is partnering with clinical-stage biotech company Molecular Partners AG to develop a new class of custom-built protein therapeutics known as DARPin®. AGC Biologics and Molecular Partners AG will work together to develop their multi-specific DARPin anti-COVID-19 program, MP0420. Molecular Partners AG plans to initiate clinical studies for this program in the second half of 2020.

AGC Biologics Expands Development Capacities for pDNA Services at Heidelberg Site

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Expansion will help meet the growing demand for plasmid DNA offerings

(SEATTLE), June 30, 2020-- Committed to continuous innovation and expansion of its service offerings, AGC Biologics has announced the expansion of its pDNA Center of Excellence in Heidelberg, Germany. The global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) is further expanding to meet the growing need for process development and manufacturing for plasmid DNA (pDNA). The 1M EUR investment in a laboratory build-out includes a significant increase of lab area, additional staffing and state-of-the-art equipment, to foster high-throughput techniques and quality by design processes. This will further expand AGC Biologics’ service portfolio and build on a track record of more than seven years in commercial plasmid manufacturing.

Calypso Biotech Completes CALY-002 Clinical Batch Manufacturing

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AGC Biologics produces humanized monoclonal antibody targeting IL-15

(SEATTLE), June 18, 2020 -- AGC Biologics, a global biopharmaceutical Contract Development Manufacturing Organization (CDMO), produces a GMP-grade clinical batch of CALY-002 for Calypso Biotech. The immunotherapy biotech company retained the services of AGC Biologics for the development of the manufacturing process and the production of its clinical supply.

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