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Company: AGC Biologics, Bothell, WA
Company Description: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) . We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA, viral vectors, and genetically engineered cells . Our work helps bring life saving treatments to patients across the globe.
Nomination Category: Company / Organization Categories
Nomination Sub Category: Company of the Year - Manufacturing - Large
 Nomination Title: AGC Biologics Drives New Era of U.S. Pharmaceutical and Biotech Manufacturing
- Which will you submit for your nomination in this category, a video of up to five (5) minutes in length about the achievements of the nominated organization since January 1 2020, OR written answers to the questions for this category? (Choose one):
Written answers to the questions
- If you are submitting a video of up to five (5) minutes in length, provide the URL of the nominated video here, OR attach it to your entry via the "Add Attachments, Videos, or Links to This Entry" link above, through which you may also upload a copy of your video.
N/A
- If you are providing written answers for your submission, you must provide an answer to this first question: Briefly describe the nominated organization: its history and past performance (up to 200 words):
Total 200 words used.
AGC Biologics is a global CDMO providing end-to-end pharmaceutical process development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, the company helps large pharmaceutical organizations and small biotech companies bring their drug products to patients in need. From development to clinical trials to full-scale commercialization, AGC Biologics offers services to support any stage in the drug development and manufacturing process, offering manufacturing services in the following modalities and substances: mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA, viral vectors, Messenger RNA (mRNA), and genetically engineered cells.
In the U.S. specifically, AGC Biologics operates three manufacturing facilities, in Seattle, Wash., and Boulder and Longmont, Colorado, respectively. The Colorado sites were acquired and added over the last two years and are two of the largest and most unique sites in the industry. The Boulder facility offers one of the largest mammalian-drug manufacturing lines in the U.S., housing two 20,000-liter stainless steel cell bioreactors that help bring large batches of needed drugs to the masses. The Longmont facility is an expansive site that serves as the company’s North American hub for cell and gene therapy manufacturing.
- If you are providing written answers for your submission, you must provide an answer to this second question: Outline the organization's achievements since the beginning of 2020 that you wish to bring to the judges' attention (up to 250 words):
Total 250 words used.
AGC Biologics accomplished the following achievements since the beginning of 2020:
- Acquired new largescale manufacturing facility in Boulder, creating more capacity for mammalian-based drug manufacturing in the U.S. This is one of the largest facilities of its kind in the industry. The company also announced new expansion plans in June 2021 to this site, featuring a new 126,000-square-foot two-story manufacturing space for even more production.
- Acquired new facility in Longmont to become the new U.S. hub of the company’s cell and gene therapy manufacturing practice. Longmont offers immediate and significant future capacity to expand AGC Biologics’ end-to-end cell and gene therapy practice. The facility gives the company a centralized hub in North America that extends its global cell and gene therapy capabilities and helps ensure the security of supply for current and future customers.
- Finalized expansion project to add new manufacturing lines at Seattle facility to help bring client products to market even quicker. These state of the art facility upgrades helped eliminate bottlenecking, also strengthened service for customers from the clinical through commercial phases, including the addition of a 500-liter mammalian cell bioreactor. This facility also became a critical resource in 2020 for Novavax Inc. and helped produce its COVID-19 vaccine.
- Finalized new contract for publicly traded company I-MAB Biopharma to product its newest late stage project at the expanded Seattle facility.
- Expanded partnership with Horizon Therapeutics plc (Nasdaq: HZNP) to produce Horizon’s Thyroid Eye Disease (TED) treatment, TEPEZZA, at AGC’s new facility in Boulder, CO.
- If you are providing written answers for your submission, you must provide an answer to this third question: Explain why the achievements you have highlighted are unique or significant. If possible compare the achievements to the performance of other players in your industry and/or to the organization's past performance (up to 250 words):
Total 117 words used.
These achievements are significant because they have allowed the AGC Biologics U.S. network to expand to three total sites and create more manufacturing capacity. Before 2020, the company only had one facility – these investments have helped it become an increasingly important player in the CDMO industry.
Further, the new partnerships with top-tier pharmaceutical companies are significant when you consider AGC Biologics was formed in 2018. New manufacturing contracts with large-scale publicly traded pharmaceutical companies - Novavax, Horizon Therapeutics, and I-MAB - show that these top companies are entrusting AGC Biologics to manufacture its treatments, helping the company create a name for itself within the CDMO space as one of the fastest-growing players in the industry.
- You have the option to answer this final question: Reference any attachments of supporting materials throughout this nomination and how they provide evidence of the claims you have made in this nomination (up to 250 words):
Total 59 words used.
Novavax COVID Partnership: https://www.prnewswire.com/news-releases/agc-biologics-expands-partnership-with-novavax-301109376.html
Horizon Boulder Partnership: https://www.agcbio.com/news/agc-biologics-and-horizon-therapeutics-plc-expand-partnership
I-MAB Seattle Partnership: https://www.agcbio.com/news/i-mab-biopharma-and-agc-biologics-partner-on-late-phase-project
Boulder Site acquisition: https://www.agcbio.com/news/agc-biologics-acquires-commercial-facility-expanding-global-service-offerings
Longmont Site Acquisition: https://www.agcbio.com/news/agc-biologics-enters-agreement-to-acquire-facility-in-longmont-co-eyeing-to-significantly-expand-their-cell-and-gene-therapy-capabilities-and-offerings
Video New AGC Biologics Boulder Mammalian Facility: https://vimeo.com/manage/videos/449832972
Video New AGC Biologics Longmont Cell & Gene Therapy Facility: https://vimeo.com/manage/videos/688018717
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