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AGC Biologics

Seattle 21511 23rd Dr. SE 98021 Bothell, WA USA Nick McDonald +1-425-485-1900 +1-425-486-0300 contactus@agcbio.com https://www.agcbio.com/

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2,400 2018

| Contract Manufacturing of Biopharmaceuticals | Process Development (Cell Line, Upstream, Downstream | Analytical Development (Bioassay, Formulation, cGMP Stability) | Quality and Regulatory | Process Validation | Microbial Fermentation and Mammalian Cell Culture | Plasmid DNA Production (pDNA services) | Messenger RNA Production (mRNA services) | Microbial Cell Banking | Bioanalytical Services | Viral Vector | Cell Therapy

AGC Biologics is a leading global Contract Development and Manufacturing Organisation (CDMO), with a strong commitment to delivering the highest standard of service to our clients and partners. The company currently employs more than 2,400 employees worldwide. Our extensive network spans three continents, with cGMP-compliant facilities in Seattle, WA; Boulder and Longmont, CO; Heidelberg, Germany; Milan, Italy; Copenhagen, Denmark; and Chiba, Japan. AGC Biologics offers deep industry expertise and unique customised services for the scale-up and cGMP manufacture of biologics (with both mammalian and microbial platforms) and cell and gene therapies: from preclinical to commercial production. Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, protein expression – including our proprietary CHEF1TM Expression System for mammalian production – viral vector manufacturing, and cell engineering.

Cell & Gene Therapy Facility Capabilities

AGC Biologics brings technical expertise to develop and optimise every aspect of cell & gene therapy development and manufacturing. Our services include messenger RNA (mRNA) and plasmid DNA (pDNA), viral vectors of different types (RVV, LVV, and AAV) in adhesion and suspension processes, and cell engineering (such as CD34+ hematopoietic stem cells, autologous and allogenic T-cells, and NK cells). For viral vectors, our ready-to-use platform capabilities are built on cell factories (up to 48L) and bioreactors (from 200L up to 2,000L) using adherent and suspension processes, designed entirely in-house. Our cell therapy capabilities cover numerous technologies, ranging from closed to open systems at different scales depending on client needs. Our quality system, cGMP manufacturing scale, facility layout, as well as regulatory qualifications, allow us to meet both clinical and commercial demand. As we perform more than 160 analytical tests in-house, AGC Biologics reduces turnaround time. With experience in manufacturing four

commercial products, we are the only C&GT CDMO with scientists that have experience bringing a product to market (Zalmoxis).

Microbial Facility Capabilities

Microbial cell banking and storage › Master cell banks and working cell banks › Production, characterisation, and storage Process development › Upstream development › Downstream development › Analytical development

Microbial manufacturing capabilities › Production of therapeutic proteins and plasmid DNA (pDNA) › Stainless steel fermenters with working volumes of 10L, 100L, 1,000L, 1,500L, and 3,000L › Continuous centrifugation harvest › Experience with E. coli, P. pastoris, and other microbial expression systems › Quality control release and stability testing

Mammalian Facility Capabilities

Mammalian cell banking and storage › Master cell banks and working cell banks › Production, characterisation, and storage

Process development › Upstream development › Downstream development › Analytical development

Mammalian manufacturing capabilities › Production of therapeutic proteins, monoclonal antibodies, fragments, and other biologics › Single-use bioreactors with working volumes of 100L, 500L, 2,000L, and up to 6x2,000L (6-PackTM) › Stainless steel capacity in Boulder, CO, USA of 2x20,000L › Experience with several mammalian expression systems; facility approved commercially by EMA,

FDA, HCA, PMDA › Quality control release and stability testing