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AGC Biologics Appoints David Stewart as the New General Manager/Site Head of the Boulder, Colorado Site

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(BOULDER), January 21, 2021 – AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced a new appointment to oversee the startup, strategic development and operational excellence in large-scale biologics production at its Boulder, Colorado site. Effective February 1, 2021, David Stewart will join the Boulder team as the General Manager/Site Head.

AGC Biologics Confirms Cell and Gene Therapy Commercial Expertise as Manufacturer of Orchard Therapeutics’ Newly Approved Libmeldy™

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(SEATTLE), January 4, 2021 – AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), is the first manufacturer of Orchard Therapeutics’ Libmeldy™, which was recently approved by the European Commission (EC) as a one-time therapy for eligible patients with early-onset Metachromatic Leukodystrophy (MLD).

Pierre Fabre Selects AGC Biologics as CDMO to Manufacture the Orphan Drug ER-004

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(SEATTLE), December 21, 2020 -- AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced its partnership with Laboratoire Pierre Fabre to manufacture ER-004 – an intra-amniotic drug that will pioneer the treatment of a rare and debilitating genetic disorder. AGC Biologics will manufacture GMP material for the next stage of clinical trial.

AGC Biologics to Expand Biopharmaceutical CDMO Capacity

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Doubling the production capacity at its site in Denmark to address strong demand

 

(SEATTLE), November 30, 2020 -- AGC Biologics announced that it will increase the production capacity of its Copenhagen facility. AGC Biologics will construct a new building on land adjacent to its current Copenhagen site, adding production floors with 2000L single-use bioreactors, labs and office space. The total investment for this expansion is estimated to be approximately €160M, and the start of operation is scheduled for 2023.

AGC Biologics and Horizon Therapeutics plc Expand Partnership

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Horizon’s TEPEZZA® (teprotumumab-trbw) treatment will be produced from AGC Biologics’ new facility in Boulder, CO

 

(SEATTLE), October 29, 2020 -- AGC Biologics, a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced that its partnership with Horizon Therapeutics plc (Nasdaq: HZNP) is expanding to produce Horizon’s Thyroid Eye Disease (TED) treatment, TEPEZZA, at AGC’s new facility in Boulder, CO. The state-of-the-art facility includes two 20,000L stainless steel mammalian bioreactors which AGC is offering to customers who need very high-volume commercial production.

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.

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