biomarc.colostate.edu

BioMARC

Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. BioMARC serves an industry need for higher containment biologics manufacturing (BSL-2, BSL-3 and Select Agent cGMP manufacturing). Process and Method Development. BioMARC specializes in high containment biologics manufacturing. Our facilities and infrastructure provide a clear and easy path from pre-clinical to GMP commercial manufacturing. Our in-house quality system and EHS pr...Since...

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BioMARC | biomarc.colostate.edu Reviews

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Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. BioMARC serves an industry need for higher containment biologics manufacturing (BSL-2, BSL-3 and Select Agent cGMP manufacturing). Process and Method Development. BioMARC specializes in high containment biologics manufacturing. Our facilities and infrastructure provide a clear and easy path from pre-clinical to GMP commercial manufacturing. Our in-house quality system and EHS pr...Since...

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BioMARC | biomarc.colostate.edu Reviews

https://biomarc.colostate.edu

Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. BioMARC serves an industry need for higher containment biologics manufacturing (BSL-2, BSL-3 and Select Agent cGMP manufacturing). Process and Method Development. BioMARC specializes in high containment biologics manufacturing. Our facilities and infrastructure provide a clear and easy path from pre-clinical to GMP commercial manufacturing. Our in-house quality system and EHS pr...Since...

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biomarc.colostate.edu

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BioMARC - Method Development

http://biomarc.colostate.edu/method-development

Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. GMP Manufacturing - Overview. Cell and Virus Banking. Type and scope of the data generated will allow for sufficient evidence of the reproducibility of the process and in accordance with the industry standards of analysis (i.e., precision, a. Ccuracy, limit of detection, limit of quantification, specificity, range and robustness). CALL US AT 1 (970) 491-8954. Fort Collins, CO 80523.

2

BioMARC - BioMARC of Colorado State University approved by FDA to manufacture biologic.

http://biomarc.colostate.edu/news/approved-by-FDA

Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. BioMARC of Colorado State University approved by FDA to manufacture biologic. Fort Collins, CO. March 22, 2014. Mdash; The Federal Drug Administration has approved Colorado State University to manufacture commercial quantities of a biologic product used by health officials to screen for a bacterial infection. BioMARC specializes in manufacturing services of biologic products that the U&...

3

BioMARC - Facilities

http://biomarc.colostate.edu/facilities

Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. Message From The Director. Located within the Foothills Campus of Colorado State University, BioMARC operates space within two buildings (Site I and Site II). Six (6) cGMP Suites. Two BSL-3/cGMP ISO 7 Clean Room Suites with ISO 5 Biosafety Cabinets. The BSL-3 suite includes:. Gowning and material transfer airlocks. BSL-3 access positive pressure ante-rooms. The BSL-2 suite includes:.

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BioMARC - Overview

http://biomarc.colostate.edu/overview

Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. Message From The Director. BioMARC is a nonprofit CMO owned and operated by CSU, and was created to translate and produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety Level 3 (BSL-3) and BSL-2 containment (including spore former containment) and Select Agent (SA) biosecurity conditions. In addition to manufacturing and testing services, B...

5

BioMARC - Commercial Manufacturing

http://biomarc.colostate.edu/commercial-manufacturing

Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. GMP Manufacturing - Overview. Cell and Virus Banking. BioMARC has the capabilities and capacity to manufacture clinical or commercial products requiring high containment. We can support novel biologics production lines and we have suites available for small-scale development runs. CALL US AT 1 (970) 491-8954. Click here to contact us via email. Fort Collins, CO 80523. Dennis Pierro, PhD.

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CSSi LifeSciences and BioMARC form strategic partnership

http://mobile.biopharma-reporter.com/Downstream-Processing/CSSi-LifeSciences-and-BioMARC-form-strategic-partnership

Cell Therapy Manufacturing and Gene Therapy Congress 2016. BPI European Summit - Dusseldorf, Germany. Biological Production Forum 2014, Ireland. Analytical (technologies and services). Strategic partnership forms single-source solution for biopharma. By Melissa Fassbender Melissa Fassbender. Last updated on 10-Jan-2017 at 19:47 GMT 2017-01-10T19:47:39Z. A nonprofit contract manufacturing service run by Colorado State University. Jim Sergi, president, CSSi LifeSciences, told Outsourcing-Pharma.com. The co...

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Message from the Director. Cell and Virus Banking. GMP Manufacturing of Biologics. High Containment (Bio)safety Policy. BioMARC serves an industry need for higher containment biologics manufacturing (BSL-2, BSL-3 and Select Agent cGMP manufacturing). Process and Method Development. BioMARC specializes in high containment biologics manufacturing. Our facilities and infrastructure provide a clear and easy path from pre-clinical to GMP commercial manufacturing. Our in-house quality system and EHS pr...Since...

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