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cGMP Protein Extraction & Purification - Virtual Tour
St. Louis, Missouri
Room Name Placeholder
View Rooms:
Extraction Room
Clarification Room
Buffer Preparation Room
Iso 8 - Room #DSP1
Iso 7 - Room #DSP2
200 L Lyophilization Room - Iso 7
Process Development Lab
Quality Control Lab
Clean Room: Iso 8 - Room #DSP1
Iso 7 - Room #DSP2
Room Features:
Room Features and Descriptions
', '<p>- Controlled, not classified (CNC)<br />- Tanks: 3 x 2,500 L Extraction Tanks and<br /> 1 x 7,000 L Buffer Tank</p>', '/etc/medialib/safc/virtual_tours/1-extraction-area-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- Controlled, not classified (CNC)<br />- Tanks: 1 x 3,200 L and 2 x 2,000 L<br />- Distributive Control Systems (DCS)', '/etc/medialib/safc/virtual_tours/2-clarification-area-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<p>- NA</p>', '/etc/medialib/safc/virtual_tours/3-buffer-prep-area-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<p>- (Class 100,000) processing suite<br />- 1054 sq. ft.<br />- Unidirectional flows, separate personnel /<br /> equipment entry airlocks, smooth cleanable<br /> walls and ceilings, minimize process drains<br /> and floor drains.</p>', '/etc/medialib/safc/virtual_tours/4-clean-room-class-10000-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<p>- (Class 10,000) processing suite<br />- 660 sq. ft.<br />- Unidirectional flows, separate personnel /<br /> equipment entry airlocks, smooth cleanable<br /> walls and ceilings, minimize process drains<br /> and floor drains.</p>', '/etc/medialib/safc/virtual_tours/5-clean-room-class-100000-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- Class 10,000 w/ a Class 100 area<br />- 255 sq. ft.', '/etc/medialib/safc/virtual_tours/6-lyophilisation-room-lr.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<p>- Purification of therapeutic proteins from either<br /> natural or transgenic sources.<br />- Synthesis or modification of biopolymers<br /> (polyamino acids, carbohydrates, and<br /> polynucleotides).<br />- Conjugation chemistry of large molecules to<br /> a variety of compounds.<br />- Development services starting from literature<br /> procedures.<br />- Adapting research quality products to GMP<br /> manufacturing.<br />- Transferring existing process for API<br /> manufacturing.<br />- Support from preclinical through<br /> commercialization including development of<br /> appropriate specifications.<br />- Identification of process controls and risk<br /> assessment, and cleaning methods.</p>', '/etc/medialib/safc/virtual_tours/7-n3-process-development-lab.Par.0001.Image.jpg', '', '', '')){kind=link}
', '<p>- Support services to the manufacture and<br /> release of Active Pharmaceutical Ingredients<br /> (APIs) according to the ICH Q7A guidelines.<br />- Services provided include raw material<br /> qualification, method development and<br /> validation, stability studies and microbiological<br /> assays, sterility testing, microbial<br /> identification, environmental monitoring and<br /> cleaning validation.<br />- Additional Cell Culture laboratory capable of<br /> testing various media using a variety of cell<br /> lines (e.g., stem cells) and the growth of cell<br /> lines used to produce therapeutic<br /> biopharmaceuticals.</p>', '/etc/medialib/safc/virtual_tours/8-n3-qc-lab-lr-jpg.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- (Class 100,000) Processing Suite<br />- 940 sq. ft.', '/etc/medialib/safc/virtual_tours/9-clean-room-class-10000-ani.Par.0001.Image.jpg', '', '', '')){kind=link}
', '- (Class 10,000) Processing Suite<br />- 600 sq. ft.', '/etc/medialib/safc/virtual_tours/10-clean-room-class-100000-ani.Par.0001.Image.jpg', '', '', '')){kind=link}