The latest news, announcements and press releases from AGC Biologics.
Today, we announced a development and manufacturing services agreement with Adaptimmune, a company working to redefine the treatment of solid tumor cancers with cell therapy. The CDMO is manufacturing the lentiviral vector used to produce letetresgene autoleucel (“lete-cel”), an engineered TCR T-cell therapy targeting the solid tumor antigen NY-ESO-1. Under this agreement, AGC Biologics will perform activities in support of Adaptimmune’s regulatory submissions for lete-cel, including process characterization, stability studies, and manufacture and supply of vectors.
Today, we announced the completion of the facility expansion for our new plasmid DNA (pDNA) and messenger RNA (mRNA) production line at our Heidelberg, Germany site.
With this expansion and added production line, AGC Biologics can now offer more plasmid material in high-quality and GMP grades and extend the services for mRNA supply. The new production line utilizes state-of-the-art single-use equipment, creating the flexibility to produce different projects simultaneously, with shorter timelines and faster project turnover – allowing the CDMO to serve more developers in need of these materials.
Today, we announced a Lentiviral vector (LVV) expansion to our AGCellerate program designed to deliver GMP material for clinical trials at an accelerated timeline. The AGCellerate LVV offering guarantees developers 1e11 total transduction units (TU) of LVV material in nine months.
Today, we announced a capacity update with the addition of three new Grade B cell therapy suites to our Longmont, CO facility. The new addition at AGC Biologics Longmont provides 2 new Process Suites and 1 new Flex suite, bringing expanded capabilities to our Colorado site. With more than 30,000 square feet of added space, the new segregated, multiproduct suites feature state-of-art modular clean room design, flexible capacity configuration, and the latest cell therapy equipment for open and closed processes, offering autologous and allogeneic cell therapy manufacturing.
AGC Biologics today announced expansion plans for the company’s Heidelberg facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects.
With this expansion, AGC Biologics is boosting its current 100L and 1,000L manufacturing capacities for a variety of different biologics projects by adding an additional GMP manufacturing line. The expansion includes a new GMP cleanroom for mRNA development and manufacturing, a new process development lab for microbial protein and cell and gene therapy (C>) projects, and additional warehouse capacity. The expanded capabilities will also allow AGC Biologics to meet the increasing demands of the rapidly growing C> market. The facility's new capabilities will be fully operational in 2023.
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced its partnership with BioNTech SE (Nasdaq BNTX) to further supply Plasmid DNA (pDNA) starting material for the Pfizer-BioNTech COVID-19 vaccine, at AGC’s Heidelberg, Germany facility.
AGC Biologics acquires Boulder, Colorado U.S.A. facility to increase global capacity and extend manufacturing scale
(SEATTLE), June 1, 2020 -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced the purchase of a state-of-the-art commercial manufacturing facility in Boulder, Colorado U.S.A. The facility, formerly owned by AstraZeneca, will provide AGC Biologics with additional capacity and significantly larger production scale. The facility is expected to begin full-scale operations and manufacturing by April 2021.
The Colorado facility is a large-scale biopharmaceutical manufacturing facility that houses two 20,000 liter (total volume) stainless steel mammalian cell bioreactors. It also has more than twenty acres with multiple opportunities for future expansions, including space for up to four more 20,000 liter bioreactors. The automated and cost effective facility is very well suited for high volume commercial production and high titer antibody processes.
AGC Biologics is rapidly expanding its customer portfolio, including a higher ratio of late phase and commercial projects, as well as advancing current projects into the commercial phase. This addition to their facility network will enable AGC Biologics to support a wider range of commercial demand.
In addition to this facility acquisition, AGC Biologics is completing major facility expansion projects at its Seattle, Copenhagen and Chiba facilities in 2020 and early 2021. “The addition of this facility supports AGC Biologics’ company-wide expansion initiative, which demonstrates our dedication to support our customers’ demand for mammalian projects, now and into the future,” says AGC Biologics CEO Patricio Massera. “This facility will enable us to continue to advance the development, manufacturing and commercial functions within our dynamic global company.”
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